Dataset Information

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial.

ABSTRACT:

Objective

Conservative pain management strategies for knee osteoarthritis (KOA) have limited effectiveness and do not employ a pain-mechanism informed approach. Pain Informed Movement is a novel intervention combining mind-body techniques with neuromuscular exercise and pain neuroscience education (PNE), aimed at improving endogenous pain modulation. While the feasibility and acceptability of this program has been previously established, it now requires further evaluation in comparison to standard KOA care.

Design

This protocol describes the design of a pilot two-arm randomized controlled trial (RCT) with an embedded qualitative component. The primary outcome is complete follow-up rate. With an allocation ratio of 1:1, 66 participants (33/arm) (age ≥40 years, KOA diagnosis or meeting KOA NICE criteria, and pain intensity ≥3/10), will be randomly allocated to two groups that will both receive 8 weeks of twice weekly in-person exercise sessions. Those randomized to Pain Informed Movement will receive PNE and mind-body technique instruction provided initially as videos and integrated into exercise sessions. The control arm will receive neuromuscular exercise and standard OA education. Assessment will include clinical questionnaires, physical and psychophysical tests, and blood draws at baseline and program completion. Secondary outcomes are program acceptability, burden, rate of recruitment, compliance and adherence, and adverse events. Participants will be invited to an online focus group at program completion.

Conclusion

The results of this pilot RCT will serve as the basis for a larger multi-site RCT aimed at determining the program's effectiveness with the primary outcome of assessing the mediating effects of descending modulation on changes in pain.

SUBMITTER: Modarresi S

PROVIDER: S-EPMC10469070 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial.

Modarresi Shirin S Pearson Neil N Madden Kim K Bennell Kim L KL Fahnestock Margaret M Neogi Tuhina T Carlesso Lisa C LC

Osteoarthritis and cartilage open 20230812 4

<h4>Objective</h4>Conservative pain management strategies for knee osteoarthritis (KOA) have limited effectiveness and do not employ a pain-mechanism informed approach. Pain Informed Movement is a novel intervention combining mind-body techniques with neuromuscular exercise and pain neuroscience education (PNE), aimed at improving endogenous pain modulation. While the feasibility and acceptability of this program has been previously established, it now requires further evaluation in comparison t ...[more]

PMID: 37664870

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Project description:The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

Project description:Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials showed significantly improved total effectiveness rates (risk ratio [Formula: see text] 1.12; 95% CI, 1.05 to 1.19; [Formula: see text] 0.0003). In addition, TCM showed a lower risk of adverse events than standard western treatments. This evidence suggests that TCM is safe and effective for improving pain, function, and wellness in treatments of knee OA. However, there is inherent clinical heterogeneity (diverse TCM formulations, controls, and treatment regimens) among the included trials. Despite these limitations, the potential analgesic effects of TCM warrant further methodologically rigorous research to determine the clinical implications of TCM on pain management in knee OA.

Project description:BackgroundTranscutaneous electrical nerve stimulation (TENS) is commonly used for the management of pain; however, its effects on several pain and function measures are unclear.ObjectiveThe purpose of this study was to determine the effects of high-frequency TENS (HF-TENS) and low-frequency TENS (LF-TENS) on several outcome measures (pain at rest, movement-evoked pain, and pain sensitivity) in people with knee osteoarthritis.DesignThe study was a double-blind, randomized clinical trial.SettingThe setting was a tertiary care center.ParticipantsSeventy-five participants with knee osteoarthritis (29 men and 46 women; 31-94 years of age) were assessed.InterventionParticipants were randomly assigned to receive HF-TENS (100 Hz) (n=25), LF-TENS (4 Hz) (n=25), or placebo TENS (n=25) (pulse duration=100 microseconds; intensity=10% below motor threshold).MeasurementsThe following measures were assessed before and after a single TENS treatment: cutaneous mechanical pain threshold, pressure pain threshold (PPT), heat pain threshold, heat temporal summation, Timed "Up & Go" Test (TUG), and pain intensity at rest and during the TUG. A linear mixed-model analysis of variance was used to compare differences before and after TENS and among groups (HF-TENS, LF-TENS, and placebo TENS).ResultsCompared with placebo TENS, HF-TENS and LF-TENS increased PPT at the knee; HF-TENS also increased PPT over the tibialis anterior muscle. There was no effect on the cutaneous mechanical pain threshold, heat pain threshold, or heat temporal summation. Pain at rest and during the TUG was significantly reduced by HF-TENS, LF-TENS, and placebo TENS.LimitationsThis study tested only a single TENS treatment.ConclusionsBoth HF-TENS and LF-TENS increased PPT in people with knee osteoarthritis; placebo TENS had no significant effect on PPT. Cutaneous pain measures were unaffected by TENS. Subjective pain ratings at rest and during movement were similarly reduced by active TENS and placebo TENS, suggesting a strong placebo component of the effect of TENS.

Project description:BACKGROUND:Few studies have investigated the effects of mobilization with movement (MWM) in patients with knee osteoarthritis (OA) compared to other procedures. Sham procedures are generally more appropriate control than using no or usual treatments. Moreover, studies investigating the widespread hypoalgesic effects of MWM in patients with knee OA are lacking. The aim was to investigate the effect of MWM on function and pain in patients with knee OA compared to sham MWM. METHODS:This is a randomized double-blind (patients and assessor) controlled trial. Forty adult patients with knee OA of grade II and above were recruited to receive either MWM treatment or sham MWM for the knee. The outcome measures included the following: a visual analogue scale (VAS) for pain, the pressure pain threshold (PPT) test, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the timed up and go (TUG) test, knee strength and knee range of motion (ROM). The measurements were taken at baseline, immediately after intervention and 2 days later. RESULTS:Compared with sham MWM, MWM resulted in greater immediate improvement in pain [mean difference (95% CI): - 2.2 (- 2.8, - 1.6)], PPT at both the knee [176 (97, 254)] and shoulder [212 (136, 288)], TUG time [- 1.6 (- 2.1, - 1.1)], knee flexor strength [2.0 (1.3, 2.7)] and extensor strength [5.7 (4.1, 7.2)] and knee flexion ROM [12.8 (9.6, 15.9)] (all, p < 0.001) but not knee extension ROM [- 0.8 (- 1.6, 0.1)] (p = 0.067). After 2 days of intervention, patients who received MWM also demonstrated a greater improvement in pain [- 1.0 (- 1.8, - 0.1)], PPT at the shoulder [107 (40, 175)], TUG time [- 0.9 (- 1.4, - 0.4)], knee flexor strength [0.9 (0.2, 1.7)] and extensor strength [2.9 (2.1, 3.9)] and knee flexion ROM [8.3 (4.7, 11.9)] (all, p ≤ 0.026). However, WOMAC scores and knee extension ROM showed no evidence of change at any stage after intervention (p ≥ 0.067). CONCLUSIONS:MWM provided superior benefits over sham MWM in terms of local and widespread pain, physical function (walking), knee flexion and extension muscle strength and knee flexion ROM for at least 2 days in patients with knee OA. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02865252 ), registered on August 12, 2016.

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Project description:IntroductionIncidence of total knee arthroplasty (TKA) is projected to rise 276% in 2030, and psychological distress affects up to 42% of people with knee osteoarthritis undergoing TKA, with demonstrated detrimental effects on postoperative outcomes. Few studies have assessed psychological treatment in people awaiting TKA, and these have been psychologist-delivered treatments. No evidence exists regarding psychologically-informed interventions delivered by health professionals currently embedded in TKA clinical pathways. The primary aim of this pilot study is to explore the safety, acceptability and feasibility of the Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy (KOMPACT) approach in people awaiting TKA.Methods and analysis51 community-dwelling adults scheduled for a primary TKA at two hospitals will be recruited to this pilot, mixed-methods, prospective randomised controlled trial with assessor blinding. Participants will be randomised in a 1:2 ratio to either usual care (education class) or usual care plus KOMPACT (2 hours 20 min of preoperative physiotherapy informed by Acceptance and Commitment Therapy). Our primary outcome measures are safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach. Secondary outcomes include health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures. Quantitative data collection was conducted at baseline, 1-2 weeks before TKA, 6 weeks after TKA and 6 months after TKA. Qualitative data collection is 1-2 weeks before TKA. Data analysis will take a quantitative-led approach with triangulation after thematic analysis of the qualitative data.Ethics and disseminationThis study has full ethics approval (HREC/18/WMEAD/440). Results from this study will be published in peer-reviewed journals and presented at local and international conferences.Trial registration numberAustralia New Zealand Clinical Trials Registry (ACTRN12618001867280p).

Dataset Information

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial.

Objective

Design

Conclusion

Publications

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial.

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