Visual Analog Scale Pain Improvement Research Articles

Clinical Outcomes of Arthroscopic Superior Capsular Reconstruction Using Fascia Lata Autograft Versus Reverse Shoulder Arthroplasty in Patients 65 Years and Older With Irreparable Rotator Cuff Tears: A Retrospective Cohort Study.

Arthroscopic superior capsular reconstruction (ASCR) and reverse shoulder arthroplasty (RSA) have both shown favorable outcomes in patients with irreparable rotator cuff tears (IRCTs). To (1) compare the clinical outcomes of ASCR versus RSA in patients aged ≥65 years with IRCTs and (2) compare serial changes in clinical outcomes between treatment groups. Cohort study; Level of evidence, 3. This study included patients with IRCTs without glenohumeral osteoarthritis who underwent either ASCR or RSA between March 2013 and December 2020 and had at least 2 years of follow-up data. We assessed active range of motion, a visual analog scale (VAS) pain score, the American Shoulder and Elbow Surgeons (ASES) score, and the Single Assessment Numeric Evaluation (SANE) score at the preoperative, short-term (postoperative 6-12 months), and final follow-up times. In total, 64 patients (ASCR, 31 patients; RSA, 33 patients) were included. The mean age of patients was 71.3 ± 4.4 and 72.9 ± 4.1 years, and the mean final follow-up duration was 42 ± 21.8 and 37.7 ± 21.7 months in the ASCR and RSA groups, respectively. At the short-term follow-up, RSA achieved significant improvements in all clinical outcomes, except for internal rotation (IR), while ASCR only showed significant improvements in VAS pain, ASES, and SANE scores. Compared with the preoperative period, both ASCR and RSA achieved significant improvements in all clinical outcomes, except for IR in the RSA group at the final follow-up. The ASCR group achieved better IR and ASES scores at the final follow-up, while the time taken to recover from pseudoparalysis was shorter after RSA. The ASCR group showed a 67.8% graft healing rate at the 1-year follow-up, while the RSA group showed 12.1% of scapular notching at the final follow-up. No other postoperative complications were observed in either group. ASCR and RSA achieved favorable clinical outcomes in the study cohort. At the short-term follow-up, RSA showed significant improvements in all clinical outcomes, except for IR, while ASCR only showed significant improvements in VAS pain, ASES, and SANE scores. At the final follow-up, however, ASCR had better IR and ASES scores compared with RSA.

Long-Term Outcomes of Primary Hip Arthroscopy With Labral Repair for Femoroacetabular Impingement: Results at Minimum 9-Year Follow-up.

Hip arthroscopy continues to advance and become increasingly commonly performed. With the evolution of techniques and instrumentation, labral repair rather than debridement has emerged as the treatment of choice for labral pathology. There remains a lack of data on long-term outcomes after labral repair. To (1) evaluate long-term patient-reported outcomes of primary hip arthroscopy with labral repair for femoroacetabular impingement, (2) report achievement rates of Patient Acceptable Symptom State (PASS) and minimal clinically important difference (MCID), and (3) investigate rates of reoperation and progression to total hip arthroplasty (THA). Case series; Level of evidence, 4. Prospectively collected data were reviewed for patients who underwent primary hip arthroscopy with labral repair between 2010 and 2013. Patients' medical records were reviewed for demographic characteristics, intraoperative findings, reoperation, and progression to THA. Patients were assessed pre- and postoperatively using the following scales: visual analog scale (VAS) for pain; Tegner activity scale; modified Harris Hip Score (mHHS); 12-item International Hip Outcome Tool (iHOT-12); Hip Outcome Score-Activities of Daily Living (HOS-ADL); HOS-Sport-Specific Subscale (HOS-SSS); and Non-Arthritic Hip Score. Patients were also surveyed for satisfaction, subjective improvement, and level of function. A total of 32 patients (n = 24 women; n = 8 men) with a mean age of 27.7 years (range, 13.6-51 years) were evaluated for a mean of 9.4 years (range, 9-12.1 years). Patients achieved significant mean improvements in VAS pain at rest of 2 points, VAS pain with use of 1.9, mHHS of 19.9 points, iHOT-12 of 33.5 points, HOS-ADL of 17.4 points, and HOS-SSS of 29.5 points (P≤ .015 for all). Eleven patients (34.4%) underwent reoperation and 4 (12.5%) progressed to THA during the study period. At the final follow-up, the MCID achievement rate was ≥68%, the PASS achievement rates ranged from 39% to 65%, and the mean patient satisfaction was 8.1 on a 1 to 10 scale, with 10 denoting most satisfied. Patients demonstrated significant postoperative improvements in pain, mHHS, iHOT-12, HOS-ADL, and HOS-SSS scores at 9 years postoperatively. The all-cause reoperation rate was 34.4%, and 12.5% of patients progressed to THA.

Functional and radiographic results of anatomic total shoulder arthroplasty in the setting of subscapularis dysfunction: 5-year outcomes analysis

Subscapularis management is a critical component to the success of anatomic total shoulder arthroplasty (TSA). Failure to heal the subscapularis can result in pain, weakness, loss of function, and revision. However, not all patients have poor outcomes. The purpose of this study is to compare patients with normal and dysfunctional subscapularis function following TSA in regard to (1) patient-reported outcome measures (PROMs); (2) range of motion (ROM) and strength; (3) achievement of minimal clinically important differences (MCIDs); and (4) specific functional internal rotation tasks. A retrospective review of patients treated with TSA for osteoarthritis with a minimum 2-year follow-up was performed to identify patients with subscapularis dysfunction. Subscapularis dysfunction was diagnosed when any degree of weakness in internal rotation was detected on physical examination (positive belly press sign). These patients were case controlled matched on a 1:3 ratio to patients with normal subscapularis function based on age and sex. PROMs, measured active motion, revision rates, patient satisfaction, and postoperative radiographic findings were compared. Population-specific institutional anchor-based MCID values were used to compare the improvement in PROM. Of the 668 patients included, 34 patients (5.1%) demonstrated evidence of subscapularis dysfunction. Mean follow-up for the normal subscapularis function cohort was 63.4±29.7 and 58.7±26.8 for the dysfunctional subscapularis cohort. Patients with subscapularis dysfunction demonstrated significantly worse postoperative Simple Shoulder Test, Single Assessment Numerical Evaluation, visual analog scale (VAS) function, VAS pain, and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) scores with higher rates of unsatisfactory results when compared to patients with normal subscapularis function. Abduction, elevation, internal rotation ROM, along with supraspinatus and external rotation strength were also significantly worse in the dysfunctional group. Similarly, these patients were more likely to have decreased ability to perform functional internal rotation tasks, with only 47% of the patients being able to reach the small of their back compared to 85% with normal subscapularis function. Radiographically, the dysfunctional cohort demonstrated higher rates of anterior subluxation (56% vs. 7%; P<.001) and glenoid loosening (24% vs. 5%; P=.004). Similarly, revision rates were significantly higher for patients with subscapularis dysfunction (8 patients, 23.5%). Nonetheless, the dysfunctional subscapularis cohort demonstrated improvements in VAS pain (4.0±3.7) and ASES (46.4±35.9) scores that exceeded MCID thresholds. Patients who develop subscapularis dysfunction after TSA have significantly worse PROMs, ROM, functional tasks of internal rotation, and radiographic outcomes, as well as increased rates of revision. Although patients show worse outcomes and high revision rates compared with their normal-functioning counterparts, these patients maintained improvement above MCID thresholds for pain and function at a mean 5-year follow-up.

Paper 36: Levels of Synovial Fluid Cytokines Predict Midterm Patient Reported Outcomes Following Arthroscopic Partial Meniscectomy

Objectives: To identify synovial fluid biomarkers associated with midterm postoperative outcomes in patients undergoing arthroscopic partial meniscectomy (APM). Methods: Subjects were prospectively enrolled in a cohort of patients who had synovial fluid aspirated from their knee on the day of surgery prior to undergoing APM. Biomarker analysis was performed. Preoperative patient-reported outcome (PRO) scores including VAS pain, Lysholm and Tegner activity score were collected preoperatively. At a minimum of 2 years of follow-up postoperative outcomes were collected. Using previously described values, patients who met the minimal clinically important difference (MCID) for Lysholm score were identified and groups were compared using parametric and non-parametric tests. Using preoperative and postoperative outcome scores, generalized linear models were used to explore the relationship between biomarkers and improvement in Lysholm Score, improvement in visual analog scale (VAS) pain score, and postoperative KOOS-PS. Results: Fifty patients were included in the study. 34 (68%) met the MCID for the Lysholm score and 16 (32%) did not. Mean age was 51 ± 9 years for the entire cohort, with no statically significant differences between the groups (p=0.35). Both groups were majority male (p=0.37) and there were no differences in BMI (0.74) or follow-up time (p=0.20). On logistic regression, increased concentration of RANTES (β = -6.30, p = 0.04) and MMP-3 (β = -15.16, p = 0.001) were predictive of less improvement in VAS pain. . For Lysholm score, higher SF levels of IL-1 RA were predictive of greater improvement (β = 12.57, p = 0.04) while higher levels of MMP-3 were predictive of reduced improvement (β = -10.34, p = 0.007). Conclusions: This study found that at the time of surgery, intraarticular levels of MMP-3 and RANTES are predictive of poorer midterm outcomes and higher pain levels following APM. Additionally, higher levels of IL-1RA at the time of surgery were associated with greater improvement in midterm Lysholm score.

Short-Term Outcomes of Jones-Specific Implant Versus Intramedullary Screw and Plate Fixation for Proximal Fifth Metatarsal Fractures

Although intramedullary screw fixation is commonly performed for proximal fifth metatarsal fractures, high rates of nonunion, refracture, and hardware prominence have been reported. The Jones Specific Implant (JSI) is a novel surgical implant which contours to the native curvature of the fifth metatarsal allowing for a more anatomic fixation. The purpose of this study was to compare short-term complication rates and outcomes of patients treated with the JSI to other fixation types such as plates and intramedullary screws. Electronic records were queried for adult patients with proximal fifth metatarsal fractures who underwent primary fixation from 2010 to 2021. All patients were treated by a foot and ankle fellowship-trained surgeon with intramedullary screws, plates, or JSI (Arthrex Inc., Naples, FL). Visual analog scale (VAS) and the American Orthopedic Foot and Ankle Score (AOFAS) were recorded and compared using univariate statistics. Eighty-five patients underwent fixation using intramedullary screw (n = 51, 60%), plate (n = 22, 25.9%), or JSI (n = 12, 14.1%) with a mean follow-up of 11.1 ± 14.6 months. The total cohort demonstrated a significant improvement in VAS pain (p < .0001) as well as AOFAS (p < .0001) scores. When comparing the cohort treated with JSI and the cohort treated with all other types of fixation, there were no significant differences in postoperative VAS or AOFAS scores. Only 3 complications, one with JSI (3.5%) required removal of the symptomatic hardware. The JSI is a novel treatment for proximal fifth metatarsal fractures, with similar early outcomes and complication rates when compared with intramedullary screw and plate fixation.

Concomitant Subchondral Bone Cysts Negatively Affect Clinical Outcomes Following Arthroscopic Bone Marrow Stimulation for Osteochondral Lesions of the Talus

To study the effects of concomitant subchondral bone cysts (SBCs) on prognosis after arthroscopic bone marrow stimulation (BMS) for osteochondral lesions of the talus (OLTs) less than 100 mm2 and to further assess the correlation between cystic OLT area, depth, or volume and postoperative outcomes. We retrospectively analyzed consecutive patients with OLTs (<100 mm2) who received BMS between April 2017 and May 2020 with a minimum follow-up of 24 months. Lesion area, depth, and volume were collected on preoperative magnetic resonance imaging. Visual analog scale (VAS), American Orthopedic Foot and Ankle Society, Karlsson-Peterson, Tegner, Foot and Ankle Ability Measure (FAAM)-Activities of Daily Life and Sports scores were assessed before surgery and at the latest follow-up. Additionally, a general linear model (GLM) and a Pearson correlation analysis (PCA) were performed to investigate the effects of concomitant cysts on postoperative results. Eighty-two patients with a mean follow-up of 39.22 ± 12.53 months were divided into non-cyst (n= 45; 39.91 ± 13.03 months) and cyst (n= 37; 38.37 ± 12.02 months) groups. There was no significant difference in the OLT area between the non-cyst and cyst groups (46.98 ± 19.95 mm2 vs 56.08 ± 22.92 mm2; P= .093), but the cyst group showed significantly greater depth (6.06 ± 1.99 mm vs 3.96 ± 1.44 mm; P= .000) and volume (248.26 ± 156.81 mm3 vs 134.58 ± 89.68 mm3; P= .002). The non-cyst group showed significantly more improvement in VAS pain, Karlsson-Peterson, Tegner, and FAAM scores than the cyst group (P < .05). The GLM indicated that SBCs negatively affected VAS pain and Tegner scores (P < .05). For OLTs with cysts, the PCA showed that an area of 90.91 mm2, depth of 7.56 mm, and volume of 428.13 mm3 were potential cutoff values associated with poor outcomes. The concomitant SBCs negatively affected the prognosis of OLTs after BMS. For OLTs with cysts, an area of 90.91 mm2, depth of 7.56 mm, and volume of 428.13 mm3 were the potential cutoff values associated with poor outcomes after BMS. Level III, retrospective comparative study.

Impact of sickle cell disease in shoulder arthroplasty: a matched cohort analysis.

Sickle cell disease (SCD) is a genetic disorder of abnormal hemoglobin synthesis that is known to cause glenohumeral avascular necrosis (AVN). Little has been published on the use of shoulder arthroplasty (SA) for the treatment of glenohumeral AVN in SCD. We report on the clinical and radiographic results and postoperative complications following SA in the patient cohort. A retrospective review was performed identifying 17 primary SAs (9 hemiarthroplasties, 7 anatomic total SAs, and 1 reverse total SA) in patients with a confirmed diagnosis of SCD and a minimum of 2-year follow-up. This cohort was matched (1:2) according to age, sex, body mass index, type of prosthesis, and year of surgery with patients who had undergone hemiarthroplasty or total SA for osteoarthritis (OA) or reverse total SA for cuff tear arthropathy. Outcomes included the visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons score, range of motion, and strength measurements in forward elevation (FE), external rotation (ER), and internal rotation (IR). Our cohort included 9 (52.9%) men with a mean age of 43yr. The average follow-up time was 5.9yr. In patients with SCD, SA provided significant improvements in VAS pain (9.1-3.8; P<.001), FE (95°-128°; P<.001), ER (24°-38°; P<.001), IR score (3.2-5.2; P<.001), FE strength (4.2-4.8; P<.001), ER strength (4.1-4.7; P<.001), IR strength (4.1-4.7; P<.001), and American Shoulder and Elbow Surgeons scores (48.6-73.5; P<.001). When compared to the matched cohort, the SCD group demonstrated higher preoperative (9.1 vs. 3.8; P<.001) and postoperative VAS scores (3.8 vs. 1.3; P<.001). Other clinical outcomes demonstrated no significant differences. There were 5 (29%) complications, 2 (11.8%) episodes of sickle cell crisis, and 3 (18%) reoperations in the SCD cohort. When compared to the matched cohort, there were no statistical differences with respect to complications (29% vs. 12%; P=.140) or reoperations (18% vs. 12%; P=.387). SA is an effective treatment modality for glenohumeral AVN in patients with SCD. Patients may expect improvements in pain, function, motion, and strength. However, final postoperative pain relief may be less than those treated with SA without SCD. Unique perioperative management is necessary to mitigate the risk of postoperative sickle cell crises.

Early Results with the Use of Synthetic Cartilage Implant Augmented with 3D Printed Baseplate to Prevent Implant Subsidence for Treatment of Hallux Rigidus

Category: Midfoot/Forefoot Introduction/Purpose: Hallux rigidus (HR) of the first metatarsophalangeal joint (MTPJ) is a common arthritic disease which causes pain and stiffness. Synthetic cartilage implant (SCI) resurfacing has become a popular treatment option since it has similar biomechanical properties as native cartilage, reduces pain, and preserves MTPJ motion. However, recent studies have reported on implant subsidence leading to SCI treatment failure and subsequent revision surgery. A novel solution involves proximally inserting a custom 3D printed baseplate in the metatarsal head to prevent SCI subsidence. The purpose of this study is to evaluate the clinical and radiographic outcomes of patients who underwent SCI resurfacing augmented with a 3D printed beasplate for the treatment of HR by a single surgeon. Methods: Electronic health records were queried from August 2017 to August 2021 for patients who were treated with SCI (Cartiva Synthetic Cartilage Implant; Cartiva Inc., Alpharetta, GA) augmented with a custom 3D printed baseplate by a single surgeon. Through a dorsal approach to the MTPJ, the custom 3D printed baseplate is inserted in the metatarsal head and the SCI implant is positioned two millimeters proud from the cortex. An akin osteotomy is then performed and fixed with a staple. For the study, surgical indications included symptomatic HR and revision of previously failed SCI treatment. Patient demographics, body mass index (BMI), medical comorbidities, and followup periods were recorded. Preoperative and postoperative range of motion, visual analog scale (VAS) pain scores, and x-ray imaging were compared. Descriptive and univariate statistics were used to analyze data. Results: Twenty-one patients underwent SCI resurfacing augmented with a 3D printed baseplate. The cohort consisted of 18 females, and presented with a mean BMI of 30.4+-5 Kg/m2, mean age of 56.4+-10 years, and mean followup of 9.8+-13 months since the procedure. Patients experienced a significant improvement in VAS pain (P=0.002) scores. The SCI augmented with 3D printed baseplate survivorship was 90.4%, with only two (9.5%) patients requiring revision to first MTPJ arthrodesis for SCI subsidence and sesamoidal arthritis. Two (9.5%) patients additionally underwent reoperation for staple removal and infection. The first MTPJ space was maintained on x-ray imaging for 19 (90.5%) patients, with only two (9.5%) patients demonstrating implant subsidence. Conclusion: SCI resurfacing augmented with a custom 3D printed baseplate demonstrated significant improvements in pain and prevented implant subsidence in patients suffering from symptomatic HR. Future prospective studies should be performed to expand upon the clinical outcomes data analyzing this novel technique to prevent SCI subsidence in the treatment for HR.

The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials.

ObjectiveMultiple studies have demonstrated the safety and effectiveness of basivertebral nerve radiofrequency ablation (BVN RFA) for improving low back pain related to the vertebral endplate. However, the influence of patient demographic and clinical characteristics on treatment outcome is unknown.DesignPooled cohort study of three clinical trials of patients with vertebral endplate pain identified by Type 1 and/or Type 2 Modic changes and a correlating presentation of anterior spinal element pain.SettingThirty-three global study centers.SubjectsPatients (n = 296) successfully treated with BVN RFA.MethodsParticipant demographic and clinical characteristics were analyzed with stepwise logistic regression to identify predictors of treatment success. Three definitions of treatment success were defined: 1) ≥50% visual analog scale pain improvement, 2) ≥15-point Oswestry Disability Index (ODI) improvement, and 3) ≥50% visual analog scale or ≥15-point ODI improvement from baseline.ResultsLow back pain of ≥5 years’ duration and higher ODI scores at baseline increased the odds of treatment success, whereas baseline opioid use and higher Beck Depression Inventory scores reduced these odds. However, the three regression models demonstrated receiver-operating characteristics of 62–70% areas under the curve, and thus, limited predictive capacity.ConclusionsThis analysis identified no demographic or clinical characteristic that meaningfully increased or reduced the odds of treatment success from BVN RFA. On the basis of these findings and the high response rates from the three analyzed trials, we recommend the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain to determine optimal candidacy for BVN RFA.

A single intraarticular platelet-rich plasma improves pain and function for patients with early knee osteoarthritis: Analyses by radiographic severity and age.

Most studies use platelet-rich plasma (PRP) requiring multiple intraarticular injections for knee osteoarthritis (OA). To investigate the efficacy of a single intraarticular PRP injection for patients with early knee OA and consider subgroup analyses of radiographic severity and age, respectively. Forty-one patients with knee OA (Kellgren-Lawrence grade 1-2) received a single PRP injection into the target knee and were assessed at baseline and 1, 3, and 6 months postinjection. The primary outcome was the mean change from baseline in the visual analog scale (VAS) pain (0-100 mm) at 6 months postinjection. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patients' satisfaction. Thirty-eight patients completed the study. The mean pain VAS decreased significantly from 45.6 ± 13.0 mm at baseline to 16.9 ± 13.4 mm, 14.0 ± 13.1 mm and 15.5 ± 14.0 mm at 1, 3 and 6-month follow-ups (p< 0.001 for all). Significant improvements in WOMAC, Lequesne index, SLS and consumption of analgesics from baseline (p< 0.001 for all) were noted at each follow-up. Patients' satisfaction was high. No serious adverse events occurred. Subgroup analyses revealed that patients with grade 1 OA showed significantly greater VAS pain reduction at 3 months (p= 0.006) and 6 months (p= 0.005) than patients with grade 2 OA. The older-age group (age > 60) showed significantly greater improvements in VAS pain, WOMAC function subscale scores and total scores at 6-month postinjection, compared with the younger age-group (age ≤ 60). The younger-age group reported better satisfaction at 1 and 3-month postinjection. One injection of PRP improved pain and function for 6 months for patients with early knee OA. This study supports putting the one-injection regimen into clinical practice. Further research is needed for more definite conclusions.

Safety and efficacy of single CHAP Hyaluronan injection versus three injections of linear Hyaluronan in pain relief for knee osteoarthritis: a prospective, 52-week follow-up, randomized, evaluator-blinded study

BackgroundThe hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients. We conducted the study comparing the efficacy and safety of single injection of Crosslinked Hyaluronic Acid Platform Hyaluronan (CHAP-HA) with 3-injection of linear hyaluronan in knee OA patients.MethodsThis was a randomized two-arms, evaluator-blinded, controlled, single-center study. Participants with knee OA received single CHAP-HA or three-injection of linear-HA. The 140 patients aged 35–85 years with radiographically confirmed knee OA were enrolled. At week 4, 12, 26, 39, and 52, visual analog scale (VAS) pain score, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, timed up and go (TUG) and subject’s adverse events (AE) of these 2 groups were recorded. Primary outcome of the differences of VAS pain score at week 26 between groups was analyzed with analysis of covariance (ANCOVA). At week 52, those who met the inclusion criteria could receive a CHAP-HA injection and being followed-up for the adverse events for 4 weeks.ResultsThe trial was conducted from September 2015 to April 2017. A total 140 subjects were available for analysis (71 in the CHAP-HA group and 69 in the linear-HA group). At 26th week, there were significant more improvements in VAS pain scores in CHAP-HA compared with linear-HA. Both CHAP-HA and linear-HA showed significant improvements in the VAS pain score at week 26 compared with the baseline, and the occurrence of adverse events during the study period showed no between-group difference. In subjects with KL = 2, both groups showed significant improvements in VAS pain scores within 26 weeks. In patients with KL = 3, only CHAP-HA group showed significant improvement in VAS pain from 4 to 39 weeks. No unexpected or severe AEs were reported.ConclusionsA single injection of CHAP-HA may be safe and more effective for 26 weeks in patients with knee OA by comparing to linear-HA; moreover, the pain relief effect of CHAP-HA may remain until 52 weeks. For patients with more severe OA, CHAP-HA was demonstrated to be more preferable to relieve OA pain. Furthermore, repeat treatment of CHAP-HA or using CHAP-HA after a three-injection HA was proved to be safe.Trial registrationClinicalTrials.gov: NCT03643588. Date: August 23, 2018 (retrospectively registered).Level of Evidence: Therapeutic Level I.

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results

IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC)...

Postoperative Outcomes Following Total Hip and Knee Arthroplasty in Patients with Pain Catastrophizing, Anxiety, or Depression

BackgroundThe relationship among pain catastrophizing, emotional disorders, and total joint arthroplasty (TJA) outcomes is an emerging area of study. The purpose of this study is to examine the association of these factors with 1-year postoperative pain and functional outcomes. MethodsA prospective cohort study of preoperative TJA patients using the Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale (HADS-A/HADS-D) was conducted. Postoperative outcomes included Visual Analog Scale (VAS) pain, Oxford, Harris Hip (HHS) and Knee Society (KSS) scores. Median regression was used to assess the pattern of relationship among preoperative clinically relevant catastrophizing (CRC) pain, abnormal HADS, and 1-year postoperative outcomes. ResultsWe recruited 463 TJA patients, all of which completed 1-year follow-up. At 1 year, CRC-rumination (adjusted median difference 1; 95% confidence interval [CI] 0.31-1.69, P = .005) and abnormal HADS-A (adjusted median difference 1; 95% CI 0.36-1.64, P = .002) were predictors of VAS pain, CRC magnification a predictor of HHS/KSS (adjusted median difference 1.3; 95% CI 5.23-0.11, P = .041), and abnormal HADS-A a predictor of Oxford (adjusted median difference 3.68; 95% CI 1.38-5.99, P = .002). CRC patients demonstrated inferior VAS pain (P = .001), Oxford (P < .0001), and HHS/KSS (P = .025). Abnormal HADS patients demonstrated inferior postoperative VAS (HADS-A, P = .025; HADS-D, P = .030) and Oxford (HADS-A, P = .001; HADS-D, P = .030). However, patients with CRC experienced significant improvement in VAS, Oxford, and HHS/KSS (P < .05) from preoperative to 1 year. Similarly, patients with abnormal HADS showed significant improvement in VAS pain and HHS/KSS (P < .05). ConclusionTJA patients who are anxious, depressed, or pain catastrophizing have inferior preoperative and postoperative pain and function. However, as compared to their preoperative status, clinically significant improvement can be expected following hip/knee arthroplasty.

Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis

Intraarticular hyaluronan or platelet-rich plasma (PRP) is widely used in the treatment of knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP remained inconclusive. This study aimed to investigate the efficacy of combined a single crosslinked hyaluronan (HYAJOINT Plus) and a single PRP versus a single PRP in patients with knee OA. In a prospective randomized-controlled trial, 85 patients with knee OA (Kellgren-Lawrence 2) were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml, 20 mg/ml) followed by 3 ml PRP (the combined-injection group, N = 43) or a single injection of 3 ml PRP (the one-injection group, N = 42). The primary outcome was the change from baseline in the visual analog scale (VAS) pain (0–00 mm) at 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction at 1, 3 and 6 months. Seventy-eight patients were available for the intention-to-treat analysis at 6 months. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at each follow-up visit (p < 0.001). Patients receiving a single PRP experienced significantly greater improvements in VAS pain than patients receiving combined injections at 1-month follow-up (adjusted mean difference: − 5.6; p = 0.017). There were no significant between-group differences in several of the second outcomes at each follow-up visit, except the WOMAC-pain and WOMAC-stiffness scores favoring the one-injection group at 1 month (p = 0.025 and p = 0.011). However, at 6-month follow-up, the combined-injection group achieved significantly better VAS pain reduction (p = 0.020). No serious adverse events occurred following injections. In conclusion, either combined injections of HYAJOINT Plus and PRP or a single PRP alone was safe and effective for 6 months in patients with Kellgren-Lawrence 2 knee OA. Combined injections of HYAJOINT Plus and PRP achieved better VAS pain reduction than a single PRP at 6 months. The results indicating a long term benefit effect of a combination of HYAJOINT Plus and PRP in a particular subset of patients with moderate knee OA need to be replicated in larger trials.ClinicalTrials.gov number NCT04315103.

Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up.

Background:There is currently no optimal method for cartilage restoration in large, full-thickness cartilage defects in older patients.Purpose:To determine whether implantation of a composite of allogeneic umbilical cord blood–derived mesenchymal stem cells and 4% hyaluronate (UCB-MSC-HA) will result in reliable cartilage restoration in patients with large, full-thickness cartilage defects and whether any clinical improvements can be maintained up to 5 years postoperatively.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:A randomized controlled phase 3 clinical trial was conducted for 48 weeks, and the participants then underwent extended 5-year observational follow-up. Enrolled were patients with large, full-thickness cartilage defects (International Cartilage Repair Society [ICRS] grade 4) in a single compartment of the knee joint, as confirmed by arthroscopy. The defect was treated either with UCB-MSC-HA implantation through mini-arthrotomy or with microfracture. The primary outcome was proportion of participants who improved by ≥1 grade on the ICRS Macroscopic Cartilage Repair Assessment (blinded evaluation) at 48-week arthroscopy. Secondary outcomes included histologic assessment; changes in pain visual analog scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and International Knee Documentation Committee (IKDC) score from baseline; and adverse events.Results:Among 114 randomized participants (mean age, 55.9 years; 67% female; body mass index, 26.2 kg/m2), 89 completed the phase 3 clinical trial and 73 were enrolled in the 5-year follow-up study. The mean defect size was 4.9 cm2 in the UCB-MSC-HA group and 4.0 cm2 in the microfracture group (P = .051). At 48 weeks, improvement by ≥1 ICRS grade was seen in 97.7% of the UCB-MSC-HA group versus 71.7% of the microfracture group (P = .001); the overall histologic assessment score was also superior in the UCB-MSC-HA group (P = .036). Improvement in VAS pain, WOMAC, and IKDC scores were not significantly different between the groups at 48 weeks, however the clinical results were significantly better in the UCB-MSC-HA group at 3- to 5-year follow-up (P < .05). There were no differences between the groups in adverse events.Conclusion:In older patients with symptomatic, large, full-thickness cartilage defects with or without osteoarthritis, UCB-MSC-HA implantation resulted in improved cartilage grade at second-look arthroscopy and provided more improvement in pain and function up to 5 years compared with microfracture.Registration:NCT01041001, NCT01626677 (ClinicalTrials.gov identifier).

Supplementation with vitamin D or ω-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial

Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects ofvitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents. We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis. Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo. A total of 147 women were screened and 69 were randomly assigned as follows: 27 to vitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P=0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P=0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P=0.39]. Neither of the intervention arms were statistically different from placebo. In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.

How can we define clinically important improvement in pain scores after biceps tenodesis?

Patient postoperative pain is an important consideration following biceps tenodesis. The visual analog scale (VAS) for pain is one of the most commonly used measures for perioperative pain assessment. Currently, there is limited understanding of clinically significant improvement in VAS pain. To define the substantial clinical benefit (SCB), patient acceptable symptomatic state (PASS), and minimal clinically important difference (MCID) for the VAS pain score in patients undergoing open subpectoral (OSPBT) or arthroscopic suprapectoral biceps tenodesis (ASPBT) at 1 year from surgery; and to identify preoperative predictors of achieving each outcome end point. Data from consecutive patients who underwent isolated biceps tenodesis between January 2014 and March 2017 were collected and analyzed. Baseline data and postoperative patient-reported outcome (PRO) scores were recorded at 1 yearpostoperatively. In order to quantify the clinical significance of outcome achievement for the VAS pain score, the MCID, PASS, and SCB were calculated. A total of 165 patients were included in the final analysis. The VAS pain score threshold for achieving MCID was defined as a decrease of 12.9 (0-100). PASS was defined as achieving a 2-year postoperative score of 27.4 points (0-100), and SCB was defined as a decrease of 25.1 (0-100) at 1-year follow-up. The rates of achieving MCID, PASS, and SCB were 73.3%, 52.8%, and 45.9%, respectively. Multivariate regression analysis demonstrated that ASPBT (P = .01) and a lower preoperative Constant-Murley score were predictive of achieving the MCID (P = .01). In contrast, a lower preoperative score on the SF-12 Physical Component Summary (P = .01) and a higher score on the preoperative American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (P < .001) were predictive of achieving the SCB and PASS, respectively. Preoperative duration of symptoms >6 months was predictive of a reduced likelihood to achieve PASS. This study identified scores for VAS pain that can be used to define clinically significant outcome after biceps tenodesis. Specifically, a decrease in pain score of 12.9 was a clinically important improvement in VAS pain, whereas a decrease of 25.1 represented the upper threshold of VAS pain improvement. Additionally, there were both modifiable and nonmodifiable factors that predicted achieving clinically significant levels of postoperative pain improvement.

Digital Care for Chronic Musculoskeletal Pain: 10,000 Participant Longitudinal Cohort Study

BackgroundChronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective.ObjectiveThis study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain.MethodsA longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity.ResultsA total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures.ConclusionsThese results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.

How Can We Define Clinically Important Improvement in Pain Scores After Hip Arthroscopy for Femoroacetabular Impingement Syndrome? Minimum 2-Year Follow-up Study

Background: Patient postoperative pain is being increasingly reported in the field of hip preservation surgery. The visual analog scale (VAS) for pain is one of the most commonly utilized measures for perioperative pain assessment. Currently, there is limited understanding of clinically significant improvement in VAS pain. Purpose: (1) To define the substantial clinical benefit (SCB), patient acceptable symptomatic state (PASS), and minimal clinically important difference (MCID) for the VAS pain score in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome after 2 years from surgery and (2) to identify preoperative predictors of achieving each outcome endpoint. Study Design: Case series; Level of evidence, 4. Methods: Data from consecutive patients who underwent primary hip arthroscopy between November 2014 and March 2017 were collected and analyzed. Baseline data and postoperative patient-reported outcome scores were recorded at 2 years postoperatively. To quantify clinical significance of outcome achievement for the VAS pain score, the MCID, PASS, and SCB were calculated. Results: A total of 976 patients were included in the final analysis. The VAS pain score threshold for achieving the MCID was defined as a decrease of 14.8; the PASS was defined as achieving a 2-year postoperative score of 21.6 points; and the SCB was defined as a decrease of 25.5 or a score of 15.4 points at 2 years. The rates of achieving the MCID, PASS, and SCB were 97.6%, 66.4%, and 71.2%, respectively. Regression analysis demonstrated that sports involvement, low body mass index, smaller preoperative alpha angle, and absence of articular damage and chondromalacia were predictive of achieving the PASS (all P < .05). Preoperative predictors for achieving the SCB included being male, no smoking history, smaller alpha angle, higher modified Harris Hip Score, and lower VAS pain score (all P < .05). Conclusion: This study identified scores for VAS pain that can be used to define clinically significant outcome after arthroscopic treatment of femoroacetabular impingement syndrome. Specifically, a decrease in pain score of 14.8 was a clinically important improvement in VAS pain, while an absolute score <15.4 or a change of 25.5 represented the upper threshold of VAS pain improvement. Additionally, there were both modifiable and nonmodifiable factors that predicted achieving clinically significant levels of postoperative pain improvement.

Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial

Background: Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. Purpose: To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form–36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). Results: The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group (P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain subscale (P = .0085) and Role Emotional Health subscale (P = .0410), as well as CGI-C values (P = .01) compared with saline control. Significant differences between groups were detected in change from baseline to 12 months in bone marrow lesion size as assessed on MRI and osteophytes in the central zone of the lateral femoral condyle, both in favor of the APS group (P = .041 and P = .032, respectively). There were no significant differences between APS and control groups in other measured secondary endpoints. Conclusion: This study provides evidence to support the safety and clinical improvement at 1-year follow-up of a single intra-articular injection of APS in patients affected by knee OA. Treatment with APS or a saline injection provided significant pain relief over the course of the study with differences becoming apparent at between 6 and 12 months after treatment. Trial Registration: NCT02138890 (ClinicalTrials.gov identifier)