search
Back to results

Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy

Primary Purpose

Acute Rotator Cuff Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gradual reloading
Rest and cryotherapy
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Rotator Cuff Tendinopathy focused on measuring Acute, rotator cuff tendinopathy, exercise, loading, ice, cryotherapy, randomised control trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gradual reloading

Rest and cryotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand questionnaire
Generic questionnaire assessing any upper limb disorders

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2016
Last Updated
February 25, 2019
Sponsor
Laval University
search

1. Study Identification

Unique Protocol Identification Number
NCT02813304
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Rotator Cuff Tendinopathy
Keywords
Acute, rotator cuff tendinopathy, exercise, loading, ice, cryotherapy, randomised control trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gradual reloading
Arm Type
Experimental
Arm Description
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.
Arm Title
Rest and cryotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gradual reloading
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Rest and cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand questionnaire
Description
Generic questionnaire assessing any upper limb disorders
Time Frame
Change from baseline at 2 weeks, change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Western Ontario Rotator Cuff index
Description
Questionnaire specific to rotator cuff disorders
Time Frame
Change from baseline at 2 weeks, change from baseline at 6 weeks
Title
Short form of Brief Pain Inventory (questions 1-6 only)
Description
Pain questionnaire
Time Frame
Change from baseline at 2 weeks, change from baseline at 6 weeks
Title
Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Time Frame
Change from baseline at 2 weeks
Title
Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Time Frame
Change from baseline at 2 weeks
Title
Percentage change in pain perception using Conditioned Pain Modulation equipment
Description
This measurement represents the effectiveness of descending inhibitory mechanisms
Time Frame
Change from baseline at 2 weeks
Title
Isometric shoulder external rotation strength
Description
Measured using hand-held digital dynamometer
Time Frame
Change from baseline at 2 weeks
Title
Isometric shoulder abduction strength
Description
Measured using hand-held digital dynamometer
Time Frame
Change from baseline at 2 weeks
Title
Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction
Description
Measured using a digital inclinometer
Time Frame
Change from baseline at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
City
Quebec City
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30622733
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.
Results Reference
derived

Learn more about this trial

Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy

We'll reach out to this number within 24 hrs