Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy

Study Overview
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Brief Summary
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The primary objective of this study is to compare the short-term effectiveness (2 and 6 weeks following the start of the rehabilitation program), in terms of symptoms and functional limitations, of a rehabilitation program centered on gradual reloading to a rehabilitation program centered on rest and cryotherapy in individuals with acute rotator cuff tendinopathy. The secondary objective is to explore the effects of these programs on shoulder control (acromiohumeral distance), subacromial structures (supraspinatus tendon thickness) and central pain modulation. The hypothesis is that the rehabilitation program centered on gradual reloading will lead to a faster improvement at week 2 and 6 when compared to the program centered on rest and cryotherapy.

Detailed Description
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44 adults (aged between 18 and 65) with acute (< 6 weeks) unilateral symptomatic RC tendinopathy will be recruited.This single-blind (assessor), parallel-group RCT will include three evaluation sessions over 6 weeks (baseline, week 2, week 6) and one meeting with the treating physiotherapist (right after the baseline evaluation). All participants will take part in the baseline evaluation. They will first complete a questionnaire on sociodemographic, symptomatology and comorbidity, as well as self-administered questionnaires that evaluate symptoms and functional limitations (DASH, WORC and BPI). Then, ultrasonographic (US) measurements of AHD and of the supraspinatus tendon and subacromial bursal thickness will be conducted. Thereafter, pain inhibitory control will be assessed using conditioned pain modulation. Finally, the corticospinal excitability of the infraspinatus muscle will be evaluated. Thereafter, participants will be randomly assigned to one of two intervention groups, and then take part in their assigned home program. At week 2 and 6, the self-administered questionnaires will be re-administered (by phone for the week 6 evaluation). A global rating of change question (with % of change since baseline) will also be completed at week 2 and 6. US measurements, conditioned pain modulation and corticospinal excitability will only be revaluated at week 2. To evaluate the effectiveness of blinding, the assessor will complete a question related to his/her opinion of the allocation at week 2. The study will be carried out at the Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS) by two different physiotherapists and in two different laboratories. Ethics approval will be obtained from Institutional Review Board of IRDPQ.

Official Title
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Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial

Conditions
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Acute Rotator Cuff Tendinopathy

Intervention / Treatment
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* Behavioral: Gradual reloading
* Behavioral: Rest and cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 65 years old Acute (< 6 weeks) unilateral symptomatic rotator cuff tendinopathy Positive sign in each of the following categories: a) painful arc of movement, b) positive Neer or Kennedy-Hawkins tests, and c) pain on resisted isometric lateral rotation or abduction, or positive Jobe test. Exclusion Criteria: Fracture at the symptomatic upper limb; Previous neck or shoulder surgery; Shoulder pain reproduced during active neck movement; Shoulder capsulitis; Clinical signs of a full thickness rotator cuff tear; Rheumatoid, inflammatory, or neurological diseases; Behavioural or cognitive problems.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gradual reloading<br>Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction (see Table 1). In a sitting position (with folded towel between body and arm), participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards. The opposite hand (the uninvolved side) will resist the lateral rotation and abduction. They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force; practice during the meeting with the treating physiotherapist using EMG recording) over five seconds. | Behavioral: Gradual reloading<br>* Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction. Participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards. The opposite hand will resist the lateral rotation and abduction. They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force) over five seconds. Then the contraction will be slowly released. A maximum pain level of 5/10 will be accepted when performing the contraction. Elevation movements will also be performed 3 times a day in the frontal, sagittal and scapular plane.<br>|
| Active Comparator: Rest and cryotherapy<br>Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes. They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel. After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain. All participants will be provided with a commercial ice wrap and a towel cloth. They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights. | Behavioral: Rest and cryotherapy<br>* Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes. They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel. After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain. All participants will be provided with a commercial ice wrap. They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand questionnaire | Generic questionnaire assessing any upper limb disorders | Change from baseline at 2 weeks, change from baseline at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff index | Questionnaire specific to rotator cuff disorders | Change from baseline at 2 weeks, change from baseline at 6 weeks | 
| Short form of Brief Pain Inventory (questions 1-6 only) | Pain questionnaire | Change from baseline at 2 weeks, change from baseline at 6 weeks | 
| Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner |  | Change from baseline at 2 weeks | 
| Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner |  | Change from baseline at 2 weeks | 
| Percentage change in pain perception using Conditioned Pain Modulation equipment | This measurement represents the effectiveness of descending inhibitory mechanisms | Change from baseline at 2 weeks | 
| Isometric shoulder external rotation strength | Measured using hand-held digital dynamometer | Change from baseline at 2 weeks | 
| Isometric shoulder abduction strength | Measured using hand-held digital dynamometer | Change from baseline at 2 weeks | 
| Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction | Measured using a digital inclinometer | Change from baseline at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute, rotator cuff tendinopathy, exercise, loading, ice, cryotherapy, randomised control trial