Acute Rotator Cuff TendinopathyNCT02813304
Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy
A study testing Gradual reloading and Rest and cryotherapy in people with Acute Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Rotator Cuff Tendinopathy
- What is being tested?
- Gradual reloading and Rest and cryotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec
About this study
Official title: Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial
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.
Read the 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.
- Conditions
- Acute Rotator Cuff Tendinopathy
- Being tested
- Gradual reloading, Rest and cryotherapy
- Keywords
- Acute, rotator cuff tendinopathy, exercise, loading, ice, cryotherapy, randomised control trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual reloadingBehavioural
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 cryotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gradual reloading | Experimental | 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. Receives: Behavioral: Gradual reloading |
| Rest and cryotherapy | Active comparator | 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. Receives: Behavioral: Rest and cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand questionnaire
Generic questionnaire assessing any upper limb disorders
Measured: Change from baseline at 2 weeks, change from baseline at 6 weeks
Secondary outcomes (8)
Western Ontario Rotator Cuff index
Questionnaire specific to rotator cuff disorders
Measured: Change from baseline at 2 weeks, change from baseline at 6 weeks
Short form of Brief Pain Inventory (questions 1-6 only)
Pain questionnaire
Measured: 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
Measured: Change from baseline at 2 weeks
Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Measured: 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
Measured: Change from baseline at 2 weeks
Isometric shoulder external rotation strength
Measured using hand-held digital dynamometer
Measured: Change from baseline at 2 weeks
Isometric shoulder abduction strength
Measured using hand-held digital dynamometer
Measured: 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
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813304
- Sponsor's protocol ID
- 2016- 494
- Status last verified
- Feb 2016
- First submitted
- 21 Jun 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30622733
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02813304
- Acronym / sponsor ID
- 2016- 494
- Conditions
- Acute Rotator Cuff Tendinopathy
- Keywords
- Acute, rotator cuff tendinopathy, exercise, loading, ice, cryotherapy, randomised control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradual reloading | Experimental | Behavioral: Gradual reloadingParticipants 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 | Active comparator | Behavioral: Rest and cryotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gradual reloadingParticipants 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. | Behavioural | Gradual reloading |
| Rest and cryotherapyParticipants 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. | Behavioural | Rest and cryotherapy |
Primary outcome
Disabilities of the Arm, Shoulder and Hand questionnaire
Time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks
Generic questionnaire assessing any upper limb disorders
8 secondary outcomes
Western Ontario Rotator Cuff index
Time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks
Short form of Brief Pain Inventory (questions 1-6 only)
Time frame: 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
Time frame: Change from baseline at 2 weeks
Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Time frame: Change from baseline at 2 weeks
Percentage change in pain perception using Conditioned Pain Modulation equipment
Time frame: Change from baseline at 2 weeks
Isometric shoulder external rotation strength
Time frame: Change from baseline at 2 weeks
Isometric shoulder abduction strength
Time frame: Change from baseline at 2 weeks
Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction
Time frame: Change from baseline at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 30622733Dupuis 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.
- Individual participant dataSharing planned: No
Related trials for Acute Rotator Cuff Tendinopathy
Recruiting
Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.
Shoulder Pain, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual reloading and Rest and cryotherapy in people with Acute Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand questionnaire (time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.