Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy
- Conditions
- Acute Rotator Cuff Tendinopathy
- Interventions
- Behavioral: Gradual reloadingBehavioral: Rest and cryotherapy
- Registration Number
- NCT02813304
- Lead Sponsor
- Laval University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gradual reloading Gradual reloading 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. Rest and cryotherapy Rest and cryotherapy 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.
- Primary Outcome Measures
Name Time Method Disabilities of the Arm, Shoulder and Hand questionnaire Change from baseline at 2 weeks, change from baseline at 6 weeks Generic questionnaire assessing any upper limb disorders
- Secondary Outcome Measures
Name Time Method Short form of Brief Pain Inventory (questions 1-6 only) Change from baseline at 2 weeks, change from baseline at 6 weeks Pain questionnaire
Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner Change from baseline at 2 weeks Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction Change from baseline at 2 weeks Measured using a digital inclinometer
Western Ontario Rotator Cuff index Change from baseline at 2 weeks, change from baseline at 6 weeks Questionnaire specific to rotator cuff disorders
Isometric shoulder external rotation strength Change from baseline at 2 weeks Measured using hand-held digital dynamometer
Percentage change in pain perception using Conditioned Pain Modulation equipment Change from baseline at 2 weeks This measurement represents the effectiveness of descending inhibitory mechanisms
Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner Change from baseline at 2 weeks Isometric shoulder abduction strength Change from baseline at 2 weeks Measured using hand-held digital dynamometer
Trial Locations
- Locations (1)
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
🇨🇦Quebec City, Quebec, Canada