Important Difference In Pain Research Articles

Histopathologic degenerative score as a predictor of minimal clinically important difference in pain and functionality following surgical treatment for disc herniation.

Lumbar disc herniation (LDH) often results in significant pain and disability, and histopathologic evaluation of intervertebral discs offers critical insights into treatment outcomes. This prospective observational study explores histopathologic (HP) changes in intervertebral discs (IVD) and their association with clinical outcomes following surgical treatment for lumbar disc herniation (LDH). A cohort of 141 patients undergoing magnetic resonance imaging (MRI)-confirmed LDH surgery underwent HP evaluation using a semi-quantitative Histopathologic Degeneration Score (HDS). Preoperatively and at a six-month follow-up, comprehensive clinical assessment included the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), with a minimal clinically important difference (MCID) calculated from ODI and VAS. Results indicated significant associations between higher HDS and adverse clinical outcomes, including persistent pain and greater disability post-surgery. Specifically, HDS ≥ 7 was predictive (OR = 6.25, 95%CI: 2.56-15.23) of disability outcomes measured with MCID-ODI (AUC: 0.692, 95%CI: 0.609-0.767, P < 0.001), and HDS ≥ 8 was predictive (OR = 1.72, 95%CI: 1.04-2.77) of persistent pain measured with MCID-VAS (AUC: 0.628, 95%CI: 0.598-0.737, P = 0.008), highlighting the diagnostic potential of HDS in assessing postoperative recovery. This study underscores the potential of HP evaluation using HDS to provide valuable insights into disease progression and outcomes in LDH patients, complementing conventional radiologic methods. The findings support the application of personalized treatment strategies based on HP findings while acknowledging challenges in interpretation and clinical implementation.

Safety and efficacy of an allogeneic adipose-derived mesenchymal stem cell preparation in the treatment of knee osteoarthritis: A Phase I/IIa randomised controlled trial

ObjectivesTo assess the safety and efficacy of an allogeneic adipose-derived mesenchymal stem cell preparation (MAG200) in the treatment of knee osteoarthritis over 12 months. DesignA single-centre, double-blind, ascending dose, randomised controlled trial. 40 participants with moderate knee osteoarthritis were randomised to receive a single intra-articular injection of MAG200 (dose cohorts:10, 20, 50, 100 ​× ​106 ​cells) or placebo. Primary objectives were safety and efficacy according to a compound responder analysis of minimal clinically important difference in pain (numerical pain rating scale [NPRS]) and function (Knee Injury and Osteoarthritis Outcome Score - Function in Daily Living subscale [KOOSADL]) at month 12. Secondary efficacy outcomes included changes from baseline in patient reported outcome measures and evaluation of disease-modification using quantitative MRI. ResultsTreatment was well tolerated with no treatment-related serious adverse events. MAG200 cohorts reported a greater proportion of responders than placebo and demonstrated clinical and statistically significant improvement in pain and clinically relevant improvement in all KOOS subscales. MAG200 demonstrated a reproducible treatment effect over placebo, which was clinically relevant for pain in the 10 ​× ​106 dose cohort (mean difference NPRS:-2.25[95%CI:-4.47,-0.03, p ​= ​0.0468]) and for function in the 20 ​× ​106 and 100 ​× ​106 dose cohorts (mean difference KOOSADL:10.12[95%CI:-1.51,21.76, p ​= ​0.0863] and 10.81[95%CI:-1.42,23.04, p ​= ​0.0810] respectively). A trend in disease-modification was observed with improvement in total knee cartilage volume in MAG200 10, 20, and 100 ​× ​106 dose cohorts, with progression of osteoarthritis in placebo, though this was not statistically significant. No clear dose response was observed. ConclusionThis early-phase study provides supportive safety and efficacy evidence to progress MAG200 to later-stage trial development. Trial registrationACTRN12617001095358/ACTRN12621000622808.

Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: a post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials

In the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trials, risankizumab demonstrated greater efficacy compared with placebo in patients with active psoriatic arthritis (PsA). This post hoc integrated analysis evaluated achieving the following efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics: ≥20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), ≥90% improvement in Psoriasis Area and Severity Index, minimal disease activity status, Low Disease Activity status (Disease Activity in Psoriatic Arthritis), and minimal clinically important difference in pain. Baseline demographics and clinical characteristics were similar between risankizumab (n = 707) and placebo (n = 700) groups. Numerically higher ACR20 response rates at week 24 (primary endpoint) were observed among the risankizumab (46.3%−60.1%) vs. placebo (15.5%−36.2%) cohorts, regardless of subgroups. At week 52, consistent proportions of patients randomized to risankizumab achieved ACR20 (48.6%−75.8%) while those initially randomized to placebo and switched to risankizumab experienced an improvement from week 24 (43.7%−63.9%), regardless of subgroups. Similar trends were observed for other efficacy measures assessing rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms. Risankizumab treatment was efficacious among patients with varying demographic and psoriatic disease characteristics through 52 weeks.

Pain as a Patient-Reported Outcome Measure in Pyoderma Gangrenosum

This survey study investigates the minimal important difference in pain indicating that a patient with pyoderma gangrenosum may be responding to treatment.

Effect of transauricular nerve stimulation on perioperative pain: a single-blind, analyser-masked, randomised controlled trial

BackgroundActivation of central autonomic pathways, including those regulating the arterial baroreflex, might reduce acute pain. We tested the hypothesis that transcutaneous auricular nerve stimulation (TAN) reduces pain after orthopaedic trauma surgery through autonomic modulation. MethodsA total of 86 participants aged >18 yr were randomly assigned to 50 min of either sham or active bilateral TAN, undertaken before, and again 24 h after, surgery for orthopaedic trauma. The primary outcome was absolute change in pain 24 h postoperatively, comparing the 100 mm visual analogue scale (VAS) before and after TAN. Secondary outcomes included the minimal clinically important difference in pain (>10 mm increase or reduction in VAS) before/after surgery, using intention-to-treat analysis. Holter monitoring, the analysis of which was masked to allocation, quantified autonomic modulation of heart rate. ResultsFrom June 22, 2021 to July 7, 2022, 79/86 participants (49 yr; 45% female) completed TAN before and after surgery. For the primary outcome, the mean reduction in VAS was 19 mm (95% confidence interval [CI]: 12–26) after active TAN (n=40), vs 10 mm (95% CI: 3–17) after sham TAN (n=39; P=0.023). A minimally clinically important reduction in postoperative pain occurred in 31/40 (78%) participants after active TAN, compared with 15/39 (38%) allocated to sham TAN (odds ratio 5.51 [95% CI: 2.06–14.73]; P=0.001). Only active TAN increased heart rate variability (log low-frequency power increased by 0.19 ms2 [0.01–0.37 ms2]). Prespecified adverse events (auricular skin irritation) occurred in six participants receiving active TAN, compared with two receiving sham TAN. ConclusionBilateral TAN reduces perioperative pain through autonomic modulation. These proof-of-concept data support a non-pharmacological, generalisable approach to improve perioperative analgesia.

Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial

Randomized, interventional trial with 1 year follow-up. Though recommended, evidence is lacking to support specific exercises to stabilize and strengthen the first carpometacarpal (CMC) joint for cases of osteoarthritis (OA). To determine in a naturalistic setting, whether standard treatment plus a home exercise program (ST+HEP) is more effective than standard treatment (ST) alone in improving Quick Disabilities of Arm, Shoulder and Hand (qDASH) scores, and secondarily, in other patient-centered (pain, function) and clinical outcomes (range of motion, strength). A total of 190 patients from a hand therapy practice in northwestern PA were enrolled by informed consent and randomized into ST or ST+HEP groups. Average age was 60 years, most were female (78%) with sedentary occupations most common (36%). ST group received orthotic interventions, modalities, joint protection education and adaptive equipment recommendations, while the ST+HEP group received a home exercise program in addition to ST for 6-12 months. Follow-up occurred at 3, 6, and 12 months. Outcomes included grip strength, pinch strength, range of motion (ROM), qDASH, Patient Specific Functional Scale (PSFS) and pain ratings. At the 6 month mark, all subjects could change groups if desired. Efficacy data analysis included both parametric and non-parametric tests. The threshold for statistical significance was 0.05 and adjusted for multiple comparisons. Repeated measures ANOVA failed to show a statistically significant difference in strength and ROM assessments between treatment groups over the 12 month follow-up (P ≥ .398). Differences between groups did not exceed 13%. Both the ST and ST+HEP groups evidenced improvement over time in most patient-focused assessments (P ≤ .011), including improvements exceeding reported clinically important differences in pain with activity and PSFS scores. Scores for these measures were similar at each follow-up period (P ≥ .080) in each group. The presence of CTS exerted no effect on outcomes; longer treatment time was weakly related to poorer qDASH and PSFS scores initially. Of those enrolled, 48% of subjects completed the study. The addition of a high-frequency home exercise program did not improve clinical or patient-centered outcomes more so than standard care in our sample however, study limitations are numerous. Both groups had decreased pain with activity and improved PSFS scores, meeting the established minimally clinically important difference (MCID) of each at 6 and 12 months. Adherence with the home program was poor and/or unknown.

Efficacy of Therapeutic Aquatic Exercise vs Physical Therapy Modalities for Patients With Chronic Low Back Pain

Therapeutic aquatic exercise is frequently offered to patients with chronic low back pain, but its long-term benefits are unclear. To assess the long-term effects of therapeutic aquatic exercise on people with chronic low back pain. This 3-month, single-blind randomized clinical trial with a 12-month follow-up period was performed from September 10, 2018, to March 12, 2019, and the trial follow-up was completed March 17, 2020. A total of 113 people with chronic low back pain were included in the experiment. Participants were randomized to either the therapeutic aquatic exercise or the physical therapy modalities group. The therapeutic aquatic exercise group received aquatic exercise, whereas the physical therapy modalities group received transcutaneous electrical nerve stimulation and infrared ray thermal therapy. Both interventions were performed for 60 minutes twice a week for 3 months. The primary outcome was disability level, which was measured using the Roland-Morris Disability Questionnaire; scores range from 0 to 24, with higher scores indicating more severe disability. Secondary outcomes included pain intensity, quality of life, sleep quality, recommendation of intervention, and minimal clinically important difference. Intention-to-treat and per-protocol analyses were performed. Of the 113 participants, 59 were women (52.2%) (mean [SD] age, 31.0 [11.5] years). Participants were randomly allocated into the therapeutic aquatic exercise group (n = 56) or the physical therapy modalities group (n = 57), and 98 patients (86.7%) completed the 12-month follow-up. Compared with the physical therapy modalities group, the therapeutic aquatic exercise group showed greater alleviation of disability, with adjusted mean group differences of -1.77 (95% CI, -3.02 to -0.51; P = .006) after the 3-month intervention, -2.42 (95% CI, -4.13 to -0.70; P = .006) at the 6-month follow-up, and -3.61 (95% CI, -5.63 to -1.58; P = .001) at the 12-month follow-up (P < .001 for overall group × time interaction). At the 12-month follow-up point, improvements were significantly greater in the therapeutic aquatic exercise group vs the physical therapy modalities group in the number of participants who met the minimal clinically important difference in pain (at least a 2-point improvement on the numeric rating scale) (most severe pain, 30 [53.57%] vs 12 [21.05%]; average pain, 14 [25%] vs 11 [19.30%]; and current pain, 22 [39.29%] vs 10 [17.54%]) and disability (at least a 5-point improvement on the Roland-Morris Disability Questionnaire) (26 [46.43%] vs 4 [7.02%]). One of the 56 participants (1.8%) in the therapeutic aquatic exercise group vs 2 of the 57 participants (3.5%) in the physical therapy modalities group experienced low back pain and other pains related to the intervention. The therapeutic aquatic exercise program led to greater alleviation in patients with chronic low back pain than physical therapy modalities and had a long-term effect up to 12 months. This finding may prompt clinicians to recommend therapeutic aquatic exercise to patients with chronic low back pain as part of treatment to improve their health through active exercise rather than relying on passive relaxation. Chinese Clinical Trial Registry: ChiCTR1800016396.

Radiographic Severity May Not be Associated with Pain and Function in Glenohumeral Arthritis.

Despite the routine use of plain radiographs to stratify the severity of glenohumeral osteoarthritis, little is known about the relationship between radiographic measures and patient-perceived pain and function. (1) What radiographic findings are associated with worse pain and function in patients with glenohumeral osteoarthritis? (2) What demographic factors are associated with worse pain and function in patients with glenohumeral osteoarthritis? This retrospective study included patients presenting for an initial office visit for primary glenohumeral osteoarthritis. Patients with other concurrent shoulder pathologic findings, prior surgery, lack of pain and functional scores, recent injection, or inadequate radiographs were excluded. Between January 2017 and January 2019, 3133 patients were eligible based on these inclusion criteria; 59% (1860) had outcome assessments and 48% (893) of those had radiographs. An additional 42% (378) of those with radiographs were excluded because of other shoulder findings, recent injection, prior surgery, or inadequate radiographs, leaving 16% (515 of 3133) who were fully analyzed in this study. A radiographic review included the joint space width, posterior humeral head subluxation, inferior humeral head osteophyte size, cystic change, and head asphericity. Additionally, radiographic arthritis was classified according to the Walch, Samilson-Prieto, and Kellgren-Lawrence classifications by two separate reviewers. Radiographic and demographic criteria as well as the presence of psychologic or mental illness were correlated with VAS Pain (range 1-10; minimal clinically important difference [MCID] 1.6), American Shoulder and Elbow Surgeons (ASES; range 0-100; MCID 13.6), Single Assessment Numeric Evaluation (SANE; range 0-100; MCID 14), and Simple Shoulder Test (SST; range 0-12; MCID 1.5) scores using univariate and multivariable regression analyses. After accounting for age, gender, and psychologic illness in the multivariable analysis, we found that patients with Samilson-Prieto Grade 4 arthrosis had lower VAS Pain scores (β = -1.9; p = 0.02) than those with Grade 0 or 1 did; however, no clinically important associations were found between Samilson-Prieto Grade 4 and ASES (β = 7; p = 0.25), SANE (β = 4; p = 0.63), or SST (β = 0.5; p = 0.62) scores. No clinically important associations were found between Kellgren-Lawrence Grade 3 and VAS Pain (β = 1.4; p = 0.10), ASES (β = -8; p = 0.22), SANE (β = -13; p = 0.11), or SST scores (β = 0.4; p = 0.66). Radiographic joint space and posterior subluxation also did not have any clinically important associations with VAS Pain or functional scores. In assessing Walch glenoid type, there was no clinically important association between glenoid type and VAS Pain (F = 3.1; p < 0.01), ASES (F = 1.9; p = 0.15), SANE (F = 0.45; p = 0.66), or SST scores (F = 0.76; p = 0.71). Men had higher SST scores than women did (β = 2.0; p < 0.01), but there were no clinically important differences in VAS Pain (β = -0.4; p = 0.04), ASES (β = 6; p < 0.01), or SANE (β = 4; p = 0.07) scores. No clinically important association was found between age or the presence of any psychologic illness and VAS Pain or functional scores. In patients with glenohumeral arthritis, no consistent clinically important differences in pain or function were discovered with respect to radiographic or demographic factors. Surgeons should understand that the pain levels of patients with glenohumeral arthritis may not parallel radiographic severity. Future studies can build on these findings by examining other non-radiographic or demographic factors that affect pain in patients with shoulder arthritis, such as psychological factors. Level III, prognostic study.

Defining minimal clinically important differences in pain and disability outcomes of patients with chronic pain treated with spinal cord stimulation.

Minimal clinically important difference (MCID) thresholds for a limited number of outcome metrics were previously defined for patients with failed back surgery syndrome (FBSS) at 6 months after spinal cord stimulation (SCS). This study aimed to further define MCID values for pain and disability outcomes. Additionally, the authors established 1-year MCID values for outcome measures with previously defined metrics commonly used to assess SCS efficacy. Preoperative and 1-year postoperative outcomes were collected from 114 patients who received SCS therapy for FBSS, complex regional pain syndrome, and neuropathic pain. MCID values were established for the numerical rating scale (NRS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), McGill Pain Questionnaire (MPQ), and Pain Catastrophizing Scale (PCS). Four established anchor-based methods were utilized to compute MCID values with two anchored questions: "Are you satisfied with SCS therapy?" and "Would you have SCS surgery again?" For each question, patients were categorized as responders if they answered "yes" or as nonresponders if they responded "no." The methodologies utilized to compute MCID scores included the average change method, minimum detectable change approach, change difference calculation, and receiver operating characteristic (ROC) analysis. Area under the ROC curve (AUC) analysis has been shown to inform the accuracy at which the MCID value can distinguish responders from nonresponders and was analyzed for each instrument. For the first time, ranges of MCID values after SCS were established for MPQ (1-2.3) and PCS (1.9-13.6). One-year MCID values were defined for all indications: NRS (range 0.9-2.7), ODI (3.5-6.9), and BDI (2-5.9). AUC values were significant for NRS (0.78, p < 0.001), ODI (0.71, p = 0.003), MPQ (0.74, p < 0.001), and PCS (0.77, p < 0.001), indicating notable accuracy for distinguishing satisfied patients. This was the first study to successfully determine MCID values for two prominent instruments, MPQ and PCS, used to assess pain after SCS surgery. Additionally, previously established MCID values for ODI, BDI, and the visual analog scale for patients with FBSS at 6 months after treatment were explored at 12 months for the most common indications for SCS. These data may better inform physicians of patient response to and success with SCS therapy.

Effects of exercise therapy in patients with acute low back pain: a systematic review of systematic reviews

BackgroundAcute low back pain is associated with pain and disability, but symptoms are often self-healing. The effectiveness of exercise therapy for acute low back pain remains uncertain with conflicting evidence from systematic reviews. The aim of this systematic review of systematic reviews was to assess the overall certainty of evidence for the effects of exercise therapy, compared with other interventions, on pain, disability, recurrence, and adverse effects in adult patients with acute low back pain.MethodsPubMed, the Cochrane library, CINAHL, PEDro, Open Grey, Web of Science, and PROSPERO were searched for systematic reviews of randomized controlled trials. Methodological quality was assessed independently by two authors using AMSTAR. Meta-analyses were performed if possible, using data from the original studies. Data for pain, disability, recurrence, and adverse effects were analyzed. Certainty of evidence was assessed using GRADE.ResultsThe searches retrieved 2602 records, of which 134 publications were selected for full-text screening. Twenty-four reviews were included, in which 21 randomized controlled trials (n = 2685) presented data for an acute population, related to 69 comparisons. Overlap was high, 76%, with a corrected covered area of 0.14. Methodological quality varied from low to high. Exercise therapy was categorized into general exercise therapy, stabilization exercise, and McKenzie therapy. No important difference in pain or disability was evident when exercise therapy was compared with sham ultrasound, nor for the comparators usual care, spinal manipulative therapy, advice to stay active, and educational booklet. Neither McKenzie therapy nor stabilization exercise yielded any important difference in effects compared with other types of exercise therapy. Certainty of evidence varied from very low to moderate.ConclusionsThe findings suggest very low to moderate certainty of evidence that exercise therapy may result in little or no important difference in pain or disability, compared with other interventions, in adult patients with acute low back pain. A limitation of this systematic review is that some included reviews were of low quality. When implementing findings of this systematic review in clinical practice, patients’ preferences and the clinician’s expertise also should be considered, to determine if and when exercise therapy should be the intervention of choice.Systematic review registrationPROSPERO: CRD46146, available at: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=46146.

Study with important limitations does not show important differences in pain and satisfaction between patients who receive opioids and those who do not after tooth extractions

Study with important limitations does not show important differences in pain and satisfaction between patients who receive opioids and those who do not after tooth extractions

Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial

Virtual reality (VR) represents a potential method for easing labor pain and in nonpregnant patients has been shown to achieve similar or greater analgesia than hydromorphone. Few studies of VR have been performed in pregnant women. The aim of this randomized controlled trial (RCT) is to evaluate whether VR is effective in reducing pain in laboring women. An open-label, RCT of nulliparous, term women in labor in a tertiary care hospital. We included women with a pain score level of 4 to 7 having regular contractions at least every 5 minutes. We excluded women who had received any pharmacologic pain relief including neuraxial analgesia and those with contraindications to VR. Participants were randomized to up to 30 minutes of either VR or the control arm (no additional intervention). Our primary outcome was the difference in differences from pre- to postintervention pain score. Prespecified secondary outcomes included postintervention pain scores, duration of intervention use, pharmacologic analgesia use, maternal vitals, and obstetric outcomes. From March 2018 to February 2019, 40 subjects were enrolled, randomized, and completed the study; 19 were randomized to control and 21 to the VR arm. Most baseline characteristics were similar between groups. For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of -0.52 (p = 0.03). There was also a difference in the proportion who had a minimum clinically important difference in pain (0% control and 23.8% VR; p = 0.049). Postintervention maternal heart rate was higher in the control arm (86.8 vs. 76.3, p = 0.01). Most other secondary outcomes did not differ. In our study, we found that VR was effective for reducing pain in women in labor as compared with those receiving no intervention. · Virtual reality (VR) represents a nonpharmacologic option for pain relief.. · VR has been little studied in pregnant or laboring women.. · VR was associated with a reduction in pain in nulliparous women in labor..

Differential Analgesia From Vibratory Stimulation During Local Injection of Anesthetic: A Randomized Clinical Trial.

Inadequate pain reduction during anesthetic injection is a significant medical and surgical problem. Vibratory distraction reduces this pain; however, there are minimal data identifying those who respond best. To quantify analgesia from vibration before anesthetic injection. In this partially blinded, single-institution trial, adult participants were randomized to intervention (vibratory anesthetic device, VAD ON) or placebo (VAD OFF). Pain was assessed using the 11-point numeric rating scale (NRS). Relative reduction in NRS between VAD OFF and ON was used to identify minimum clinically important and substantially clinically important difference in pain. One hundred one tested sites from 87 subjects were assessed. Sixty-three percent were men with a median age of 66 years. From univariate analysis, males, subjects aged <60, and head and neck (HN) treated subjects had a significant reduction in NRS (p < .05). Multivariate analysis identified NRS reductions in females <60 (p = .012), males ≥70 (p = .002), females and males treated on HN (p = .048 and p = .035, respectively), and males ≥70 treated on HN (p = .012). Substantially clinically important difference (≥57% NRS reduction) included subjects <60, females <70, HN treatment aged 60 to 69, males ≥70, and females treated on HN. Vibratory anesthetic device reduces pain during anesthetic injection, primarily for HN treatments and older male subjects.

Tramadol for osteoarthritis.

Tramadol for osteoarthritis.

Does Tourniquet Use in TKA Increase Postoperative Pain? A Systematic Review and Meta-analysis.

Although tourniquets are commonly used during TKA, that practice has long been surrounded by controversy. Quantifying the case for or against tourniquet use in TKA, in terms of patient-reported outcomes such as postoperative pain, is a priority. The purpose of this study was to meta-analyze the available randomized trials on tourniquet use during TKA to determine whether use of a tourniquet during TKA (either for the entire procedure or some portion of it) is associated with (1) increased postoperative pain; (2) decreased ROM; and (3) longer lengths of hospital stay (LOS) compared with TKAs performed without a tourniquet. We completed a systematic review and meta-analysis using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines to assess the impact of tourniquet use on patients after TKA. We searched the following databases from inception to February 1, 2015, for randomized controlled trials meeting prespecified inclusion criteria: PubMed, Embase, and Cochrane Central Register of Controlled Trials. Postoperative pain was the primary outcome. Secondary outcomes were postoperative ROM and LOS. The initial search yielded 218 studies, of which 14 met the inclusion criteria. For our primary analysis on pain and ROM, a total of eight studies (221 patients in the tourniquet group, 219 patients in the no-tourniquet group) were meta-analyzed. We also performed a subgroup meta-analysis on two studies that used the tourniquet only for a portion of the procedure (from osteotomy until the leg was wrapped with bandages) and defined this as half-course tourniquet use (n = 62 in this analysis). The Jadad scale was used to ascertain methodological quality, which ranged from 3 to 5 with a maximum possible score of 5. Statistical heterogeneity was tested with I and chi-square tests. A fixed-effects (inverse variance) model was used when the effects were homogenous, which was only the case for postoperative pain; the other endpoints had moderate or high levels of heterogeneity. Publication bias was assessed using a funnel plot, and postoperative pain showed no evidence of publication bias, but the endpoint of LOS may have suffered from publication bias or poor methodological quality. We defined the minimum clinically important difference (MCID) in pain as 20 mm on the 100-mm visual analog scale (VAS). We found no clinically important difference in mean pain scores between patients treated with a tourniquet and those treated without one (5.23 ± 1.94 cm versus 3.78 ± 1.61 cm; standardized [STD] mean difference 0.88 cm; 95% confidence interval [CI], 0.54-1.23; p < 0.001). None of the studies met the MCID of 20 mm in VAS pain scores. There was also no clinically important difference in ROM based on degrees of flexion between the two groups (49 ± 21 versus 56 ± 22; STD mean difference 0.8; 95% CI, 0.4-1.1; p < 0.001). Similarly, we found no difference in mean LOS between groups (5.8 ± 4.4 versus 5.9 ± 4.6; STD mean difference -0.2; 95% CI, -0.4 to 0.1; p = 0.25). A subgroup meta-analysis also showed no clinically important difference in pain between the full-course and half-course tourniquet groups (5.17 ± 0.98 cm versus 4.09 ± 1.08 cm; STD mean difference 1.31 cm; 95% CI, -0.16 to 2.78; p = 0.08). We found no clinically important differences in pain or ROM between patients treated with and without tourniquets during TKA and no differences between the groups in terms of LOS. In the absence of short-term benefits of avoiding tourniquets, long-term harms must be considered; it is possible that use of a tourniquet improves a surgeon's visualization of the operative field and the quality of the cement technique, either of which may improve the long-term survivorship or patient function, but those endpoints could not be assessed here. We recommend that the randomized trials discussed in this meta-analysis follow patients from the original series to determine if there might be any long-term differences in pain or ROM after tourniquet use. Level I, therapeutic study.

Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial.

Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate myofascial release (MFR) protocol on pain, disability, and fear-avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty-four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain Questionnaire (SF-MPQ) and visual analog scale (VAS), disability measured with Roland Morris Questionnaire, and fear-avoidance beliefs measured with Fear-Avoidance Beliefs Questionnaire. Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% confidence interval [CI]: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the Fear-Avoidance Beliefs Questionnaire score also displayed a significant decrease in the MFR group (P < 0.05) as compared to sham MFR. MFR therapy produced a significant improvement in both pain and disability. Because the minimal clinically important differences in pain and disability are, however, included in the 95% CI, we cannot know whether this improvement is clinically relevant. 2.

126 Determining the Minimally Clinical Important Difference in Pain, Quality of Life, and Disability for Spinal Cord Stimulation for Failed Neck and Failed Back Syndromes

126 Determining the Minimally Clinical Important Difference in Pain, Quality of Life, and Disability for Spinal Cord Stimulation for Failed Neck and Failed Back Syndromes

Spinal pain--good sleep matters: a secondary analysis of a randomized controlled trial.

The estimated prevalence of poor sleep in patients with non-specific chronic low back pain is estimated to 64% in the adult population. The annual cost for musculoskeletal pain and reported poor sleep is estimated to be billions of dollars annually in the US. The aim of this cohort study with one-year follow-up was to explore the role of impaired sleep with daytime consequence on the prognosis of non-specific neck and/or back pain. Secondary analysis of a randomized controlled trial, including 409 patients. Patients with good sleep at baseline were more likely to experience a minimal clinically important difference in pain [OR 2.03 (95% CI 1.22-3.38)] and disability [OR 1.85 (95% CI 1.04-3.30)] compared to patients with impaired sleep at one-year follow-up. Patients with non-specific neck and/or back pain and self-reported good sleep are more likely to experience a minimal clinically important difference in pain and disability compared to patients with impaired sleep with daytime consequence.

The effect of lower extremity nerve decompression on health-related quality of life and perception of pain in patients with painful diabetic polyneuropathy: a prospective randomized trial.

The aim of this study was to assess whether surgical decompression of nerves in the lower extremity in people with painful diabetic polyneuropathy would have an effect on health-related quality of life and to determine minimal clinically important differences in pain and quality of life scores. The design was a randomized controlled trial in which 42 participants with painful diabetic painful neuroapthy underwent unilateral decompression of nerves in their left or right leg, using the other leg as a control, with 12 months follow-up. Surgical decompression was performed at the tibial, superficial, deep and common peroneal nerves. Preoperatively, and at 6 and 12 months post operatively, a visual analogue scale for pain and the 36 item short-form health survey and EuroQual 5 Dimensions questionnaires were completed. At 12 months follow-up, the visual analogue scale was significantly reduced, but decompression surgery did not significantly alter health-related quality of life scores. The minimal clinically important difference for visual analogue scale reduction was determined at 2.9 points decrease, a threshold reached by 42.5% of the study population. Although decompression surgery does not influence health-related quality of life, it achieves a clinically relevant reduction of pain in ~42.5% of people with diabetic peripheral neuropathy. It can therefore be considered for patients who do not adequately respond to pain medication.

A comparison of pain levels after the Biering-Sorensen and the modified 20-metre shuttle test in patients with chronic low back pain

The Biering-Sorensen Test (BST) is a useful and well validated assessment tool in patients with chronic lumbar pain. However there is sometimes concern that it may lead to an unwarranted increase in pain. This study compared pain levels before and after the BST against a currently accepted functional assessment tool- the modified 20-metre shuttle test (MST)- in military patients with chronic low back pain. 56 patients with non-specific lumbar pain of more than three months duration were tested on admission and discharge from a three week in-patient rehabilitation programme using the BST and the MST. A questionnaire was used to assess pain levels before and after both tests on admission and discharge from the group. The BST was carried out before the MST, with a time delay of 30-60 minutes. There were significant increases in pain immediately after both the MST and the BST (range of mean increase: 2.2 to 3.2 points, p< 0.001). The mean absolute levels of pain after the BST on admission and discharge were 0.26 and 0.80 more than the levels after the MST. The mean increases were 0.36 and 1.16 more after the BST compared to that after the MST. Pain levels returned to normal within 60 minutes of the BST being completed. Using either comparison method, although the initial increases after the BST were slightly more, the amounts were comparable and much less that the minimal clinically important difference in pain which is 1.5.