Exploring biomarkers of change in movement-evoked pain in Achilles tendinopathy: A secondary analysis of a randomized controlled trial.

Patterns of movement-evoked pain during tendon loading and stretching tasks in Achilles tendinopathy: A secondary analysis of a randomized controlled trial

Category: Sports Introduction/Purpose: Insertional Achilles Tendinopathy (IAT) affects 5% of the general population and up to 20% of the athletic population. Despite trials of non-surgical management such as physical therapy and heels lifts, more than 50% of patients ultimately pursue surgery. One hypothesis regarding the development of IAT pain and stiffness is that ankle dorsiflexion and associated calcaneal impingement causes transverse compression of the tendon insertion, inducing metaplastic changes within the Achilles tendon, and bursa, contributing to inflammation. Thus the aim of the current study is to examine the effect of a home exercise program designed to minimize compression of insertional tissues for patients with IAT on patient reported outcomes (PRO) measures at 3 months and one year. Methods: Thirty-five patients with IAT were enrolled in the study from May 2014 until June 2015 as two separate cohorts (21 and 14 patients, respectively) of whom 26 completed the study (mean age: 56.7 + 10.1 years, BMI: 29.5 + 6.0 kg/m2, 58% women). One patient elected for surgery prior to completing the physical therapy protocol. Physical therapy exercises were progressive eccentric loading of the Achilles tendon and seated isometric plantar flexion that were performed 4 times a week for 3 months. The Victorian Institute of Sport Assessment – Achilles (VISA-A), the Foot and Ankle Ability Measure (FAAM) and the SF-36 questionnaires were completed at baseline and at the completion of the 3-month physical therapy protocol. Six of the 14 patients in the second cohort returned for a 1 year follow up visit; four patients were lost to follow up and 4 had undergone surgical intervention prior to 1-year follow up. Results: Completion of the 3 month protocol resulted in statistically significant improvements in VISA-A, FAAM ADL and sports scores as well as multiple subcategories of the SF-36 (physical function, role limiting physical function, energy/vitality, social functioning and general pain). Twenty-two of the 26 patients (~85%) that completed the study had clinically significant, greater than MCID, improvements in their VISA-A and/or FAAM scores. In the second cohort, all six patients that returned for a one year follow up assessment maintained their improved VISA-A and FAAM scores observed at the end of the initial physical therapy protocol. Of the four patients that underwent surgical intervention prior to follow up, two did not demonstrate improvement in any of their outcomes following the initial study period. Conclusion: The results of the present study suggest that a physical therapy home exercise program utilizing eccentric and isometric Achilles exercises may result in a greater improvement in functional outcomes compared to other exercise programs that do not progressively increase both ankle dorsiflexion and Achilles tendon loading. Furthermore, improvements in pain and function result in increased energy and social wellbeing. Finally, symptomatic improvement that occurs after 3 months is likely to persist for at least one year following initial treatment.

Category: Ankle, Hindfoot, Sports Introduction/Purpose: Insertional Achilles Tendinopathy (IAT) affects 5% of the general population and up to 20% of the athletic population. Despite trials of non-surgical management, over 50% of patients ultimately pursue surgery. Previously in healthy controls it was demonstrated that ankle dorsiflexion tasks increase transverse compressive strain (force perpendicular to the tendon fibers) most in the deep region of the tendon insertion, where IAT is often most severe. Thus the purpose of this study was to utilize a novel physical therapy protocol that combines isometric and eccentric exercises in order to increase transverse compressive strain and decrease axial tensile strain (force parallel to tendon fibers) in patients with IAT and to determine whether this corresponds with improved patient outcome scores. Methods: Forty-two patients with IAT were enrolled in the study from May 2014 to June 2016, of which twenty-seven patients (mean age: 56.7 + 9.9 years, BMI: 29.6 + 5.9, 56% women) completed the study. A subset (n=15, mean age 58.9 + 8.6 years, BMI: 30.0 + 4.0, 47% women) underwent ultrasound elastography to determine transverse compressive and axial tensile strain in the Achilles tendon during dorsiflexion tasks. Patients were then placed on a physical therapy protocol that focused on progressive loading of the Achilles tendon while avoiding ankle dorsiflexion. Seated isometric plantar flexion, bilateral eccentric heel lowering, and single limb heel lowering exercises were utilized. Questionnaires validated for use in Achilles tendinopathy, the Victorian Institute of Sport Assessment – Achilles (VISA-A) and the Foot and Ankle Ability Measure (FAAM), were completed at the beginning and at the completion of the study. Results: Twenty-three of 27 subjects that completed the study, had clinically significant improvements in their VISA-A (mean change 19.3) or FAAM ADL and sports scores (mean change 16.2 and 22.6, respectively). Ultrasound elastography revealed that the deep region of the Achilles tendon experienced more transverse compressive strain and less axial tensile strain compared to the superficial portion of the tendon when standing. Completion of the physical therapy program resulted in increased transverse compressive strain in the superficial Achilles tendon compared to the pre-therapy value when standing (mean change 52%, p=0.043). Moreover, there was a decrease in axial tensile strain within the deep portion of the tendon in response to physical therapy (mean change 53% p=0.0434). Conclusion: Treatment of IAT patients with a physical therapy protocol utilizing a combination of isometric and eccentric exercises results in improved outcomes, as measured by VISA-A and FAAM questionnaires. Furthermore, ultrasound elastography suggests that while the physical therapy protocol increases the transverse compressive strain in the superficial portion of the Achilles tendon, it results in decreased axial tensile strain in the deep portion of the tendon. Therefore, it is likely that the combination of these two exercise modalities result in the improved clinical outcomes observed in our patients with IAT after undergoing this physical therapy protocol.

An Exploratory Analysis of Gender as a Potential Modifier of Treatment Effect Among Patients in a Randomized Controlled Trial of Integrative Acupuncture and Spinal Manipulation for Low Back Pain

ObjectiveTo develop and evaluate a modified version of the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire, for use in sedentary patients with Achilles tendinopathy, using the Consensus-based Standards for the...

High-volume peritendinous injections in the management of Achilles tendinopathy

Current evidence suggests that lumbosacral transforaminal epidural steroid injection (TFESI) is an effective treatment for lumbosacral radicular pain. However, practitioners may be reluctant to attempt this intervention in obese patients because of a perceived reduction in the chance of providing pain relief due to the increased technical difficulty of TFESI in individuals with a larger body habitus. No study to date has compared the effectiveness of TFESI in groups stratified by BMI. We report pilot data addressing whether lumbosacral transforaminal epidural steroid injection is as effective in treating lumbosacral radicular pain in the obese and overweight population as it is in the non-overweight population. This study consisted of 9 normal weight (18.5 < BMI < 25), 9 overweight (25 < BMI < 30), and 6 obese (BMI > 30) patients who presented with lumbosacral radicular pain and received a TFESI. For each group, percent reduction in pain and the proportion of individuals with a 50% or greater reduction in pain 2-4 weeks after TFESI was determined. Comparing the overweight and obese groups to the normal weight group, no significant differences were found in the percent improvement in pain after TFESI (p=0.7154, p=0.4566) or in the proportion of each group with a 50% or greater reduction in lower back pain after TFESI (p=0.2968). Our pilot data indicates that lumbosacral TFESI is as effective in providing short-term relief of lumbosacral radicular pain in obese and overweight patients as it is in non-overweight patients. However, our sample size was not large enough to find a significant difference at a power of 80%. We plan to perform a larger prospective study to confirm the findings of this study. Case-control study, Level II-2.

Understanding the impact of pain response on changes in function, quality of life, and sleep interference in patients with painful diabetic peripheral neuropathy and post-herpetic neuralgia treated with pregabalin

BackgroundAchilles tendinopathy is considered to be one of the most common overuse injuries in elite and recreational athletes and the recommended treatment varies. One factor that has been stressed in the literature is the lack of standardized outcome measures that can be used in all countries. One such standardized outcome measure is the Victorian Institute of Sports Assessment – Achilles (VISA-A) questionnaire, which is designed to evaluate the clinical severity for patients with Achilles tendinopathy. The purpose of this study was to cross-culturally adapt the VISA-A questionnaire to Swedish, and to perform reliability, validity and structure evaluations.MethodsCross-cultural adaptation was performed in several steps including translations, synthesis of translations, back translations, expert committee review and pre-testing. The final Swedish version, the VISA-A Swedish version (VISA-A-S) was tested for reliability on healthy individuals (n = 15), and patients (n = 22). Tests for internal consistency, validity and structure were performed on 51 patients.ResultsThe VISA-A-S had good reliability for patients (r = 0.89, ICC = 0.89) and healthy individuals (r = 0.89–0.99, ICC = 0.88–0.99). The internal consistency was 0.77 (Cronbach's alpha). The mean [95% confidence interval] VISA-A-S score in the 51 patients (50 [44–56]) was significantly lower than in the healthy individuals (96 [94–99]). The VISA-A-S score correlated significantly (Spearman's r = -0.68) with another tendon grading system. Criterion validity was considered good when comparing the scores of the Swedish version with the English version in both healthy individuals and patients. The factor analysis gave the factors pain/symptoms and physical activityConclusionThe VISA-A-S questionnaire is a reliable and valid instrument and comparable to the original version. It measures two factors: pain/symptoms and physical activity, and can be used in both research and the clinical setting.

ObjectivePeer mentoring has been shown to be an effective intervention for chronic conditions with evidence to suggest that it might improve health-related bodily pain among African American women living with systemic lupus erythematosus (SLE). However, there is a lack of evidence to describe the intervention impact when adjusting for self-management of SLE. The present work aims to determine whether greater patient activation is associated with greater reductions in pain overall and within intervention groups.MethodsData were used from the Peer Approaches to Lupus Self-Management study, a randomised controlled trial designed to determine the efficacy of peer mentorship in African American women with SLE. A total of 274 participants were randomised to an intervention (mentorship) or control (non-mentorship) arms. Data were collected on self-reported Lupus Quality of Life questionnaire for bodily pain and Patient Activation Measure (PAM). Linear mixed models and multivariable linear mixed models were fit to assess the intervention and impact of PAM on bodily pain over time.ResultsIncreased patient activation was significantly associated with greater reductions in bodily pain (b=−0.13, p=0.019); however, there was no significant difference in intervention group over the study period between the intervention and control groupsConclusionPatient self-management can have a significant effect on bodily pain for SLE patients. Future work aims to consider strategies which address patient activation as a mechanism for reducing pain and improving quality of life.Trial registration numberNCT03734055.

Background:Behçet’s syndrome, a chronic, multi-system variable vessel vasculitis, is often characterized by painful oral ulcers (OU) affecting quality of life (QoL). Apremilast (APR), an oral PDE4 inhibitor, demonstrated efficacy in OU treatment in the phase 3 multinational RELIEF study.Objectives:To evaluate APR efficacy in OU treatment in patients with active Behçet’s syndrome in a prespecified subgroup of patients enrolled in 13 European RELIEF sites (France, Germany, Greece, and Italy).Methods:patients were adults with active Behçet’s syndrome and ≥3 OU at randomization or ≥2 OU at screening and randomization, without active major organ involvement. Patients were randomized (1:1) to APR 30 mg BID or PBO during a 12-week double-blind phase. The primary endpoint was area under the curve for the number of OU through Week 12 (AUCWk0-12). Other outcomes were OU pain visual analog scale (VAS); achievement of OU complete response (ie, OU-free) and maintenance of OU complete response (ie, complete response at Week 6 and remaining OU-free for ≥6 additional weeks); OU partial response (ie, OU reduction ≥50%); disease activity (Behçet’s Syndrome Activity Score [BSAS]; Behçet’s Disease Current Activity Form [BDCAF], including Behçet’s Disease Current Activity Index [BDCAI], and Patient’s and Clinician’s Perception of Disease Activity); and QoL (BDQoL; Short Form Health Survey version 2 [SF-36v2], including Physical Functioning [PF] scale and Physical and Mental Component Summary [PCS, MCS]).Results:Of 207 patients randomized and treated in RELIEF, 52 were in the European subgroup. Mean (±SD) age in the subgroup was 39 (±12) years; 54% were women. Baseline disease characteristics were similar between treatment groups (Table 1). Patients receiving APR achieved lower AUCWk0-12 for OU vs PBO (Figure 1) and greater reduction in pain. A greater proportion of patients receiving APR achieved complete, maintained, or partial OU responses at Week 12 vs those receiving PBO (Table 1). Consistent treatment effects favoring APR vs PBO were observed in disease activity, as shown by BSAS and BDCAF component scores at Week 12 (Table 1). Greater improvement in SF-36v2 MCS was observed favoring APR vs PBO at Week 12, and moderate treatment differences were seen for other QoL measures (BDQoL, SF-36v2 PF, and SF-36v2 PCS).Conclusion:In the European subgroup of patients with Behçet’s syndrome and OU in RELIEF, APR resulted in greater reduction in OU count, OU pain, and disease activity as well as favorable treatment effect on QoL measures than PBO. These results are consistent with the efficacy of APR treatment in the overall RELIEF population.Baseline Disease Characteristics, Mean*PBO (n = 27)APR (n = 25)Duration of BD, years9.08.2OU count3.84.0OU pain (VAS 0-100)60.664.2BSAS (0-100)38.741.4BDCAI (0-12)3.53.6BDQoL (0-30)10.59.0Efficacy Outcomes at 12 Weeks*PBO (n = 27)APR (n = 25)Treatment Difference [95% CI]OU pain (VAS 0-100), mean†–17.7–48.7–31.0 [–44.7, –17.3]OU complete response, n (%)‡4 (14.8)16 (64.0)51.5 [29.8, 73.3]OU maintained response, n (%)‡1 (3.7)8 (32.0)26.7 [7.4, 46.0]OU partial response, n (%)‡11 (40.7)21 (84.0)46.0 [23.9, 68.0]BSAS (0-100)†,§–5.23–20.68–15.5 [–22.6, –8.3]BDCAI (0-12)†,§–0.0–1.4–1.4 [–2.2, –0.6]Patient’s Perception of Disease Activity†,§–0.4–1.6–1.2 [–2.1, –0.4]Clinician’s Overall Perception of Disease Activity†,§−0.6−1.7–1.0 [–1.7, –0.4]BDQoL (0-30)†,§–1.25–2.37–1.12 [–3.8, 1.5]SF-36v2 MCS (0-100)†,§–2.14.26.3 [2.2, 10.4]*ITT population.†LS mean of the change from baseline at Week 12.‡Non-responder imputation for missing data.§LOCF approach. All efficacy endpoints (except BDQoL) were significant at the level of P&lt;0.05.Acknowledgements :This study was funded by Celgene. Additional analyses were funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Kristin Carlin, RPh, MBA, of Peloton Advantage, LLC, an OPEN Health company.Disclosure of Interests:Alfred Mahr Speakers bureau: Chugai; Roche, Consultant of: Celgene; Chugai, Gulen Hatemi Speakers bureau: AbbVie, Novartis, and UCB, Grant/research support from: Celgene, Mitsuhiro Takeno Speakers bureau: AbbVie, Esai, and Mitsubishi-Tanabe, Consultant of: Celgene, Grant/research support from: Novartis, Doyoung Kim: None declared, Melike Melikoglu: None declared, david Saadoun Consultant of: AbbVie, Celgene, Janssen, and Roche, Grant/research support from: AbbVie and Roche, Christos C. Zouboulis Speakers bureau: Amgen, Galderma, Pierre Fabre, PPM and Sobi, Consultant of: AbbVie, AccureAcne, Almirall, Bayer Healthcare, GSK/Stiefel, Incyte, Inflarx, Janssen, Novartis, PPM, Regeneron, and UCB, Grant/research support from: Celgene, NAOS-BIODERMA, and Relaxera, Sue Cheng Employee of: Amgen Inc, Sven Richter Employee of: Amgen Inc, Shauna Jardon Employee of: Amgen Inc, Maria Paris Employee of: Amgen Inc, Mindy Chen Employee of: Amgen Inc, Yusuf Yazici Consultant of: Bristol-Myers Squibb, Celgene, Genentech, and Sanofi

To compare the effects of spinal thrust manipulation and electrical dry needling (TMEDN group) to those of nonthrust peripheral joint/soft tissue mobilization, exercise, and interferential current (NTMEX group) on pain and disability in patients with subacromial pain syndrome (SAPS). Randomized, single-blinded, multicenter parallel-group trial. Patients with SAPS were randomized into the TMEDN group (n = 73) or the NTMEX group (n = 72). Primary outcomes included the Shoulder Pain and Disability Index and the numeric pain-rating scale. Secondary outcomes included the global rating of change scale (GROC) and medication intake. The treatment period was 6 weeks, with follow-ups at 2 weeks, 4 weeks, and 3 months. At 3 months, the TMEDN group experienced greater reductions in shoulder pain and disability (P<.001) compared to the NTMEX group. Effect sizes were large in favor of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC score of 5 or greater) and stopped taking medication (P<.001). Cervicothoracic and upper-rib thrust manipulation combined with electrical dry needling resulted in greater reductions in pain, disability, and medication intake than nonthrust peripheral joint/soft tissue mobilization, exercise, and interferential current in patients with SAPS. The effects were maintained at 3 months. J Orthop Sports Phys Ther 2021;51(2):72-81. Epub 28 Aug 2020. doi:10.2519/jospt.2021.9785.

Background:Extracorporeal shockwave therapy (ESWT) is a noninvasive treatment modality that is used in the treatment of chronic Achilles tendinopathy (AT).Purposes:To (1) retrospectively assess outcomes after ESWT for both noninsertional AT (NAT) and insertional AT (IAT) at >1-year follow-up and (2) identify potential predictors of outcomes.Study Design:Cohort study; Level of evidence, 3.Methods:Chart review was conducted to identify patients who underwent ESWT for AT with a minimum of 1-year follow-up. Data collected and assessed included patient demographic characteristics, pathological characteristics including the location of AT (NAT or IAT), presence of a Haglund deformity, and severity of tendon degeneration on magnetic resonance imaging (MRI), in addition to treatment characteristics including number of sessions and intensity of ESWT. The Victorian Institute of Sports Assessment–Achilles (VISA-A) and visual analog scale (VAS) pain scores were obtained before ESWT, 6 months after ESWT, and at final follow-up. Failures were also recorded, which were defined as no improvement in VISA-A or VAS scores or need for surgical intervention. Linear regression was performed to identify potential predictors of inferior subjective clinical outcomes and failures. Survival analysis was conducted using Kaplan-Meier curves.Results:The study included 52 patients with IAT and 34 patients with NAT. The mean follow-up in the NAT cohort was 22.3 ± 10.2 months and the mean follow-up in the IAT cohort was 26.8 ± 15.8 months. Improvements in VISA-A and VAS scores were observed in the NAT cohort at 6-month follow-up and at final follow-up (P < .05). Improvements in VISA-A and VAS scores were recorded in the IAT cohort at 6-month follow-up, which subsequently deteriorated at final follow-up. In the NAT cohort, the failure rate at 6-month follow-up was 11.8%, which increased to 29.4% at final follow-up. In the IAT cohort, the failure rate at 6-month follow-up was 32.7%, which increased to 59.6% at final follow-up. Predictors of inferior subjective clinical outcomes and failures in the NAT cohort included pre-ESWT subjective clinical score, male sex, presence of a cardiovascular risk factor, and more severe MRI grading of tendinopathy. Predictors of inferior subjective clinical outcomes and failures in the IAT cohort included pre-ESWT subjective clinical score and more severe MRI grading of tendinopathy.Conclusion:Superior subjective clinical outcomes together with a lower failure rate were maintained for >1 year in the NAT cohort compared with the IAT cohort, calling into question the long-term benefit of ESWT for patients with IAT.

Background:The Victorian Institute of Sport Assessment–Achilles (VISA-A) questionnaire is validated and widely used in Achilles tendinopathy. How well it can evaluate treatment outcomes is not well understood.Purpose:To evaluate the responsiveness of the VISA-A in midportion Achilles tendinopathy and compare it with other patient-reported outcome measures.Study Design:Cohort study (diagnosis); Level of evidence, 2.Methods:Enrolled were 97 participants with clinically diagnosed Achilles tendinopathy (median age, 50 years [interquartile range, 18 years]; symptom duration, 10 months [interquartile range, 28.7 months). The participants underwent a baseline evaluation and completed between 1 and 6 follow-up evaluations at 8, 16, 24, 32, 40, and/or 48 weeks. Participants completed the VISA-A, the Patient Reported Outcomes Measurement Information System short form Version 2.0 (PROMIS) Physical Function and Pain Interference subscales, and the Tampa Scale for Kinesiophobia (TSK). Three thresholds were evaluated with a receiver operating characteristic analysis (minimal clinically important difference [MCID], substantial benefit [SB], and complete recovery [CR]) using an 11-point global rating of change scale as an anchor. Thresholds were evaluated on raw scores as well as changes from baseline.Results:The VISA-A was able to detect all 3 thresholds for changes over time, with raw scores >70.5, >77.5, and >89.5 representing the MCID, SB, and CR, respectively; thresholds for changes from baseline on the VISA-A were increases of 23.5, 19.5, and 37.5 points from baseline, respectively. The PROMIS subscale raw scores had identical thresholds for SB and CR (52.45 for Physical Function and 45.6 for Pain Interference). A score <34.5 on the TSK was the threshold for SB.Conclusion:The VISA-A was the most responsive outcome measure evaluated. Raw scores had increasingly higher thresholds for the MCID, SB, and CR, which were therefore logically consistent.

Reduction in movement-evoked pain and fatigue during initial Transcutaneous Electrical Nerve Stimulation treatment predicts responders in women with fibromyalgia