Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
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|ClinicalTrials.gov Identifier: NCT04175184|
Recruitment Status : Unknown
Verified November 2020 by Rafael Baeske, Federal University of Health Science of Porto Alegre.
Recruitment status was: Recruiting
First Posted : November 22, 2019
Last Update Posted : October 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Injuries Shoulder Pain||Other: Mobilisation with Movement Other: Sham Mobilisation with Movement||Not Applicable|
Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable.
Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction,
Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trial, placebo-controlled, with a parallel group design|
|Masking:||Double (Participant, Outcomes Assessor)|
Blinding of participants: participants will be unaware about the specificities of the group allocation. The inclusion of a sham mobilisation with movement (MWM) procedure has the aim to mask the manual therapy procedure. For a naive participant, it is unlikely that he/she might be able to discern the real MWM from the sham MWM. In addition, participants will be requested to avoid discussing the interventions received with the outcome assessor.
A scale ranging from "treatment under investigation" to "I don´t know" will be used to assess blinding of participants.
Blinding of outcome assessor: this research assistant will only be responsible for conducting the outcome assessments. He/she will be unaware of group allocation and will also be requested not to discuss any specifics about the treatment programmes with the participants
|Official Title:||The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Experimental group
Other: Mobilisation with Movement
MWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results.
The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion.
Sham Comparator: Placebo group
Other: Sham Mobilisation with Movement
Sham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms.
- Shoulder Pain Disability Index (SPADI). [ Time Frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up. ]SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
- Visual Analogue Scale (VAS) for pain. [ Time Frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up. ]VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
- Active pain-free range of motion. [ Time Frame: Changes from baseline and study completion (5 weeks). ]
Active pain-free range of motion will be assessed for flexion, abduction (Kolber et al, 2011), external rotation (Cools et al, 2014) and hand behind back (Satpute et al, 2016). An inclinometer (Baseline, Enterprises Inc) will be used to measure the ranges of motion.
All measurements will be conducted to the onset of pain.
- Pain pressure threshold [ Time Frame: Changes from baseline and study completion (5 weeks). ]
Measurements will be collected at three different sides: 5 cm distal to the lateral border of the acromion on both sides over the deltoid muscle, and 10 cm distal to the tibiofemoral joint line, over the tibialis anterior muscle on the unaffected side (Paul et al, 2012). A calibrated digital algometer (Wagner instruments, model FPX 25) will be used to assess the pain pressure threshold.
An interval of 30 seconds will be respected between measurements.
- Global rating scale of change (GROC) [ Time Frame: Through study completion and 4 weeks follow-up. ]GROC is designed to measure a patient's improvement or deterioration over time as a result of an intervention.The amplitude of this difference is scored on a numerical or visual analogue scale. In this research a 15 point scale will be used (Kamper et al, 2009).
- Expectations of physiotherapy [ Time Frame: Change at 3 weeks of treatment from baseline ]
The scale to be used in this study to assess expectation has been previously used in patients with shoulder disorders (Chester et al, 2018). Participants will answer the following question: "How much do you expect your shoulder problem to change as a result of physiotherapy treatment?. Please circle one box only".
Possible answers are: Completely recover, Much improve, Slightly improve, No change, Slightly worse, Much worse, Worse than ever.
- Chronic Pain Self-Efficacy Scale [ Time Frame: Baseline ]Self-efficacy is considered an important predictor of patients with shoulder pain (Chester et al, 2018). The domains of pain (5 questions) and function (9 questions) of the chronic pain self-efficacy scale will be used in this study (Salvetti & Pimenta, 2005). Values range from 10 to 100, higher values indicate greater self-efficacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175184
|Contact: Rafael Baeske, PhD student||+55 51 firstname.lastname@example.org|
|Contact: Marcelo Faria, PhD||+55 51 email@example.com|
|Albrecht - Clínica Integrada de Reabilitação||Recruiting|
|São Leopoldo, Rio Grande Do Sul, Brazil, 93020-080|
|Contact: Rafael Baeske, PhD +55 51 981702422 firstname.lastname@example.org|
|Contact: Selma Albrecht +55 51 30372720 email@example.com|
|Faculdades Integradas de Taquara||Not yet recruiting|
|Taquara, Rio Grande Do Sul, Brazil, 95612-150|
|Contact: Rafael Baeske, PhD student +55 51 981702422 firstname.lastname@example.org|
|Contact: Selma Albrecht +55 51 30372720 email@example.com|
|Principal Investigator:||Marcelo Faria, PhD||Federal University of Health Science of Porto Alegre|