Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy

Acute Rotator Cuff Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813304
• Other study ID #: 2016- 494
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2016
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Behavioral:
• Gradual reloading
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.
• 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. They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.

Locations

Country	Name	City	State
Canada	Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario Rotator Cuff index	Questionnaire specific to rotator cuff disorders	Change from baseline at 2 weeks, change from baseline at 6 weeks
Secondary	Short form of Brief Pain Inventory (questions 1-6 only)	Pain questionnaire	Change from baseline at 2 weeks, change from baseline at 6 weeks
Secondary	Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner		Change from baseline at 2 weeks
Secondary	Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner		Change from baseline at 2 weeks
Secondary	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
Secondary	Isometric shoulder external rotation strength	Measured using hand-held digital dynamometer	Change from baseline at 2 weeks
Secondary	Isometric shoulder abduction strength	Measured using hand-held digital dynamometer	Change from baseline at 2 weeks
Secondary	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