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Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

ABSTRACT: Subacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical trial on achilles tendinopathy rESWT improved the effectiveness of treatment with eccentric loading. The objective of this present study is to evaluate if rESWT in addition to SE is more effective in improving shoulder pain and function compared with sham rESWT and SE in patients with subacromial shoulder pain.This is a double blind, randomised sham-controlled trial which is performed at the shoulder clinic at the Department of Physical Medicine and Rehabilitation in Oslo University Hospital, Norway. One-hundred-forty-four patients with subacromial shoulder pain lasting at least 3 months, age from 25 to 70 years old are included in the trial. Patients are randomly allocated in 1:1 ratio to receive either rESWT or sham rESWT once a week in addition to SE once a week for the initial 4 weeks. Subsequently SE are provided twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24 weeks follow-up. Secondary outcomes include return to work, pain at rest and on activity, function, and health related quality of life. The patients, the physiotherapist providing the exercise regimen and the outcome assessor are blinded to group assignment. The physiotherapist providing the rESWT is not blinded.Because of the extensive use of rESWT in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice.ClinicalTrials.gov NCT01441830.

SUBMITTER: Kvalvaag E

PROVIDER: S-EPMC4567817 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

Kvalvaag Elisabeth E Brox Jens Ivar JI Engebretsen Kaia Beck KB Søberg Helene Lundgaard HL Bautz-Holter Erik E Røe Cecilie C

BMC musculoskeletal disorders 20150911

<h4>Background</h4>Subacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical ...[more]

PMID: 26361756

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Project description:BackgroundPlantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up.Methods/designA double-blind, randomised, sham-controlled trial is conducted at a hospital outpatient clinic of physical medicine and rehabilitation. Patients with chronic (> 3 months) pain due to plantar fasciopathy, aged 18 to 70 years old, are eligible for inclusion in the trial. Patients will be randomly allocated in 1:1 ratio to receive rESWT, sham-rESWT, standardised exercises or usual care. The sample size is estimated to 200 patients, 50 in each group. rESWT or sham-rESWT will be given once a week for 3 weeks. A physiotherapist will supervise the exercises, with a total of 8 sessions over 12 weeks. The patients in the usual care group will receive information, advice and foot orthosis only. All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician. The primary outcome measure is heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10) at the 6 months follow-up adjusted for baseline pain intensity. The secondary outcomes are at the 6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12 months). The patients receiving rESWT/sham-rESWT and the outcome assessor will be blinded to the group assignment.DiscussionThis trial is designed in order to provide results important for future clinical practice.Trial registrationClinicalTrials.gov NCT03472989 . Registered on 14 March 2018.

Project description:BACKGROUND:Acute injuries of the hamstring muscle complex (HMC) type 3b (interfascicle/bundle-tear) are frequently observed in various sports disciplines both in elite and recreational sport. The treatment of choice of acute HMC injuries type 3b is a progressive physiotherapeutic exercise programme. Besides this, there is currently only insufficient scientific evidence to support other treatment methods, including local infiltrations and injections of platelet-rich-plasma. Very recently, it was demonstrated that extracorporeal shock wave therapy (ESWT) may accelerate regeneration after acute skeletal muscle injury. The aim of the present study is to test the hypothesis that the combination of radial ESWT (rESWT) and a specific rehabilitation program (RP) is effective and safe in treatment of acute HMC injury type 3b in athletes, and is statistically significantly more effective than the combination of sham-rESWT and RP. METHODS:We will perform a double blind, randomized, sham-controlled clinical trial at the clinic KinEf Kinesiología Deportiva, Ciudad Autónoma de Buenos Aires, Argentina. Forty patients with acute HMC injury type 3b will be randomly allocated to receive either rESWT (nine rESWT sessions; three sessions per week; 2500 radial extracorporeal shock waves (rESWs) per session; energy density depending on what the patient tolerates) or sham-rESWT. In addition, all patients will receive a specific rehabilitation program that will last for 8 weeks. The primary outcome measure will be the individual time (days) necessary to return to play. Secondary outcomes will include the presence or absence of reinjury during a time period of 6 months after inclusion into the study. DISCUSSION:Because of the lack of adequate treatment options for acute HMC injury type 3b in athletes and particularly the high reinjury rate, we hypothesize that the results of this trial will be of importance and have impact on clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03473899 . Registered March 22, 2018.

Project description:BackgroundExercise is recommended for patients with subacromial pain. It has been suggested that good exercise adherence improves clinical outcomes. Despite this, little attention has been paid to the need for behavioural frameworks to enhance adherence to home exercise programmes for patients with subacromial pain.MethodsA feasibility study with pre-post design was used. Participants aged > 18 years, with subacromial pain, who had received conservative treatment during the past 6 months, were recruited. The Ad-Shoulder intervention consisted of 1-5 individual sessions provided over 3 months and was based on 5 self-management skills, which aimed to enhance the patients' self-efficacy and adherence to self-managed exercises. The primary objectives were assessed according to predefined progression criteria: (1) the recruitment rate (10 patients enrolled within 12 weeks), (2) follow-up rate (≥ 80% on all self-reported measures), (3) objective physical activity measures (≥ 80% of participants would contribute valid data at each time point), (4) adherence with the self-managed exercises (≥ 80% of the participants would adhere to ≥ 80% of the assigned home exercise programme), (5) fidelity of the delivery of the intervention (the therapists delivered the intervention according to the protocol) and (6) adverse events (< 30% would report adverse events (including mild)). The results were reported using descriptive statistics.ResultsEleven patients were recruited during 16 weeks. Ten patients completed the self-reported measures at baseline and week 12. Objective physical activity measures were successfully obtained for 100% (11/11) at baseline, 64% (7/11) at week six and 82% at week 12. Fifty-five percent (6/11) of the participants satisfactorily completed at least 80% of their home exercise programme. All sessions were delivered according to the protocol. None of the patients reported any adverse events.ConclusionsObjective physical activity data measures at baseline and week 12, follow-up, the physiotherapists' fidelity to the intervention and adverse events met our pre-specified progression criteria. Recruitment and adherence to the self-managed exercise programme were both below the anticipated level. Further intervention development is necessary to understand whether adherence to the self-managed exercises could be enhanced and additional methods of recruitment would need to be considered, including additional recruitment sites, in any planning for a future main trial.Trial registrationClinicalTrials.gov, NCT04190836 , Registered December 9, 2019-retrospectively registered.

Dataset Information

Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

Publications

Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.

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