Clinical trial NCT02813304: Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy
Official title: Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Rotator Cuff Tendinopathy
Keywords: Acute
rotator cuff tendinopathy
exercise
loading
ice
cryotherapy
randomised control trial
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: Change from baseline at 2 weeks, change from baseline at 6 weeks
Secondary outcomes:
measure: Western Ontario Rotator Cuff index
timeFrame: Change from baseline at 2 weeks, change from baseline at 6 weeks
measure: Short form of Brief Pain Inventory (questions 1-6 only)
timeFrame: Change from baseline at 2 weeks, change from baseline at 6 weeks
measure: Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
timeFrame: Change from baseline at 2 weeks
measure: Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
timeFrame: Change from baseline at 2 weeks
measure: Percentage change in pain perception using Conditioned Pain Modulation equipment
timeFrame: Change from baseline at 2 weeks
measure: Isometric shoulder external rotation strength
timeFrame: Change from baseline at 2 weeks
measure: Isometric shoulder abduction strength
timeFrame: Change from baseline at 2 weeks
measure: Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction
timeFrame: Change from baseline at 2 weeks
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
state: Quebec
Study officials:
References:
citation: Dupuis F, Barrett E, Dube MO, McCreesh KM, Lewis JS, Roy JS. Cryotherapy or gradual reloading exercises in acute presentations of rotator cuff tendinopathy: a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Dec 26;4(1):e000477. doi: 10.1136/bmjsem-2018-000477. eCollection 2018.