Rotator Cuff TendinopathyPASENCT05124769
PAin During Shoulder Exercise
A study testing Pain Allowing Program (PAllow) and Pain Avoiding Program (PAvoid) in people with Rotator Cuff Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Overuse shoulder injuries such as rotator cuff (RC) tendinopathy are common with a prevalence estimated to be 14% in the general population of which 23% of the working population with shoulder problems are sick listed. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Pain Allowing Program (PAllow) and Pain Avoiding Program (PAvoid)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jan 2022to 13 Jan 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 55 years
- Shoulder symptoms lasting for a minimum of 3 months
- Clinical diagnosis of rotator cuff (supraspinatus and/or infraspinatus) tendinopathy
- Clinical diagnosis verified by/ combined with ultrasound
Who cannot join
- Patients are excluded if they have
- resting pain above 4/10 (NPRS)
- <90 degrees active elevation of the arm
- had a corticosteroid injection within the previous 12 weeks
- isolated subscapularis tendinopathy
- total rotator cuff tear
Show all 11Show fewer
- diagnosed AC-joint pathology
- diagnosed labrum pathology
- diagnosed glenohumeral joint instability
- had prior shoulder surgery (all shoulder joints)
- diagnosed glenohumeral osteo arthrosis (OA) evaluated on x-ray, rheumatoid arthritis or periarthrosis General exclusion criteria are inability to speak or read Danish, inability to perform and maintain the physical training, or other conditions negatively influencing compliance.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg and Frederiksberg Hospital
Copenhagen NV, Danmark, 2400
About this study
Official title: Allowing Pain Versus Avoiding Pain During Shoulder Exercises: Does Pain Matter in the Effectiveness of an Exercise Program in Patients With Rotator Cuff Tendinopathy?
Overuse shoulder injuries such as rotator cuff (RC) tendinopathy are common with a prevalence estimated to be 14% in the general population of which 23% of the working population with shoulder problems are sick listed.
RC tendinopathy is a tendon-related pain in the proximal lateral aspect of the upper arm with weakness, especially during active elevation and external rotation, and painful active range of motion. The prevalence of RC tendinopathy is highest in the supraspinatus and infraspinatus tendon.
Read more
Exercise therapy is regarded as an effective intervention for symptomatic RC tendinopathy for reducing pain and disability and improving function. However, the prescription is diverse and the effectiveness of specific characteristics of exercise programs is unknown. Many contextual factors and prescription parameters, such as external resistance, training intensity and frequency, home versus supervised exercises, duration of the program, etc. have been described. Some of these prescription parameters have been extensively studied, with some conflicting results. Although some level of resistance seems to matter, as well as number of sets and repetitions, the 'optimal' level and volume are unclear. Inducing or allowing pain based on tendon loading during exercises is todays consensus in the treatment of patellar and achilles tendinopathy using a pain-monitoring model. Although a number of shoulder studies report that pain either should be avoided or allowed, not one study ever examined the influence of pain allowance versus pain avoidance during a shoulder exercise program on patient outcome in terms of pain, physical function and disability.
The purpose of this project is to examine the effect of allowing pain versus avoiding pain based on tendon loading during an exercise regimen for patients with symptomatic rotator cuff (RC) tendinopathy. This will be accomplished in a Randomized Controlled Clinical Trial, comparing the effectiveness on patient reported and objective outcomes of a "pain allowing" and "pain avoiding" exercise program, performed for 26 weeks. Our hypothesis is that allowing pain based on tendon loading during exercises would result in a better outcome in pain and function measured on SPADI (the primary outcome) compared to avoiding pain in patients with RC tendinopathy.
Read the detailed description
Aim The purpose of this project is to examine the effect of allowing pain versus avoiding pain based on tendon loading during an exercise regimen for patients with symptomatic rotator cuff (RC) tendinopathy. This will be accomplished in a Randomized Controlled Clinical Trial, comparing the effectiveness on patient reported and objective outcomes of a "pain allowing" and "pain avoiding" exercise program, performed for 26 weeks.
Background Shoulder disorders are the third most common musculoskeletal disorder with a life-time prevalence in the general population of 30%. Shoulder disorders are often persistent and recurrent, with 54% of the patients reporting on-going symptoms after 3 years. RC tendinopathy is regarded as a common source of shoulder pain with prevalence estimated to be as high as 14% in the general working-age population. About 23% of the working population with shoulder problems are sick-listed, with a potential individual productivity loss.
RC tendinopathy is a tendon-related pain in the proximal lateral aspect of the upper arm with weakness, especially during active elevation and external rotation, and painful active range of motion. The pathoanatomic understanding is extended by classifying tissue irritability and specific impairments. Tissue irritability is meant to guide intensity of treatment, and identifying specific impairments guides specific tactics used for intervention. The prevalence of RC tendinopathy is highest in the supraspinatus and infraspinatus tendon.
Exercise therapy is widely regarded as an effective intervention for symptomatic RC tendinopathy for reducing pain and disability and improving function. It is well known that tendon collagen regains formation and tensile strength faster than unstressed collagen, and that it can take 12 month or longer before it reaches full maturity and strength. However, the prescription is diverse and the effectiveness of specific characteristics of exercise programs is unknown. Many contextual factors and prescription parameters, such as external resistance, training intensity and frequency, home versus supervised exercises, duration of the program, etc. have been described and are summarized in a systematic review. Some of these prescription parameters have been extensively studied, with some conflicting results. Although some level of resistance seems to matter, as well as a number of sets and repetitions, the 'optimal' level and volume are unclear. The existing studies offer some preliminary guidance in relation to the development and application of loading in exercise programs for RC tendinopathy, however there is a gap in literature with respect to allowing or avoiding pain during shoulder exercises. Inducing or allowing pain based on tendon loading during exercises is todays consensus in the treatment of patellar and achilles tendinopathy using a pain-monitoring model.
Although a number of shoulder studies report that pain either should be avoided or allowed, not one study ever examined the influence of pain allowance versus pain avoidance during a shoulder exercise program on patient outcome in terms of pain, physical function and disability.
Hypothesis Allowing pain based on tendon loading during exercises would result in a better outcome in pain and function measured on SPADI (the primary outcome) compared to avoiding pain in patients with RC tendinopathy.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Pain Allowing Program (PAllow), Pain Avoiding Program (PAvoid)
- Keywords
- rotator cuff, tendinopathy, tendinosis, shoulder, overuse injuries
- Medical subject headings
- Tendinopathy, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Allowing Program (PAllow)Behavioural
Performing exercises considered to have a considerable supraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of > 40% MVC).
Pain Avoiding Program (PAvoid)Behavioural
Performing exercises selected to have a minimal insupraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of <20% MVC).
These unloading exercises are performed for 6 weeks. In the second part of the exercise protocol, the "loading" exercises are applied, however without pain.
In case the patient still feels pain during the exercises in that period, the "unloading" exercises are continued.
| Study group | Role | What they receive |
|---|---|---|
| Pain Allow | Experimental | Pain is allowed up to 5/10 during exercises, monitored by NPRS. Depending on tissue irritability and other factors such as ROM, the exercises may be performed in an isometric way, or dynamic. Receives: Behavioral: Pain Allowing Program (PAllow) |
| Pain Avoid | Active comparator | Pain is not allowed during the exercises, and should be <2/10, monitored by NPRS. Receives: Behavioral: Pain Avoiding Program (PAvoid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Self-reported measure of pain and function. The responses are indicated on a visual analogue scale where 0 = no pain/no difficulty and 10 = worst imaginable pain/so difficult it requires help. The items are summed and converted to a total score out of 100 where a high score indicates greater pain and disability in patients with shoulder disorders.
Measured: 26-week
Secondary outcomes (7)
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Self-reported measure of pain and function. The responses are indicated on a visual analogue scale where 0 = no pain/no difficulty and 10 = worst imaginable pain/so difficult it requires help. The items are summed and converted to a total score out of 100 where a high score indicates greater pain and disability in patients with shoulder disorders.
Measured: 52-week
Change from baseline in Disabilities Arm, Shoulder and Hand questionnaire (DASH)
Self-reported measure of pain, function and quality of life. The questionnaire score ranges from 0 to 100 where 0 equals no disability and 100 equals the most severe disability.
Measured: 26 and 52 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Self-reported measure of pain. The score ranges from 0 to 10 where 0 equals no pain and 10 equals the most severe pain.
Measured: 26 and 52 weeks
Patient Acceptable Symptom State (PASS)
Self-reported measure of symptom acceptability. The PASS threshold is determined by asking patients if they are satisfied with their current health state. Patients respond to this question with "yes" or "no".
Measured: 6, 26 and 52 weeks
Global Rating Scale (GRS)
Self-reported measure of change of condition. The GRS is used to obtain a general impression of recovery from baseline to 26 and 52 weeks after baseline with the question: "Compared to when this treatment first started, how would you describe your shoulder this last week?" This is assessed on a 15-point scale where - 7 represents vastly worse, 0 represents unchanged, and + 7 represents much better.
Measured: 6, 26 and 52 weeks
Change from baseline in Range-of-motion (ROM) in scapular plane elevation (standing) and in external (supine in 90° abduction)
Objective measure
Measured: 26 and 52 weeks
Change from baseline in Isometric muscle strength (MVC) in shoulder elevation in scapular plane and external shoulder rotation
Objective measure
Measured: 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start11 Jan 2022
- Primary completion30 Jun 2024
- Study completion13 Jan 2025
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 Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial with parallel assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Hougs Kjær, Bispebjerg Hospital
- Investigators
- Birgitte H Kjær, Ph.D, Principal investigator, Bispebjerg and Frederiksberg Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124769
- Sponsor's protocol ID
- BispebjergH_PASE_BKjaer
- Acronym
- PASE
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kjaer BH, Cools AM, Johannsen FE, Trostrup J, Bieler T, Siersma V, Magnusson PS. To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial). Trials. 2024 Feb 21;25(1):135. doi: 10.1186/s13063-024-07973-6.
PubMed 38383459
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allowing Pain Versus Avoiding Pain During Shoulder Exercises: Does Pain Matter in the Effectiveness of an Exercise Program in Patients With Rotator Cuff Tendinopathy?
- ClinicalTrials.gov ID
- NCT05124769
- Acronym / sponsor ID
- PASE / BispebjergH_PASE_BKjaer
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- rotator cuff, tendinopathy, tendinosis, shoulder, overuse injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 18 Nov 2021 (actual)
- 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.
Overuse shoulder injuries such as rotator cuff (RC) tendinopathy are common with a prevalence estimated to be 14% in the general population of which 23% of the working population with shoulder problems are sick listed.
RC tendinopathy is a tendon-related pain in the proximal lateral aspect of the upper arm with weakness, especially during active elevation and external rotation, and painful active range of motion. The prevalence of RC tendinopathy is highest in the supraspinatus and infraspinatus tendon.
Exercise therapy is regarded as an effective intervention for symptomatic RC tendinopathy for reducing pain and disability and improving function. However, the prescription is diverse and the effectiveness of specific characteristics of exercise programs is unknown. Many contextual factors and prescription parameters, such as external resistance, training intensity and frequency, home versus supervised exercises, duration of the program, etc. have been described. Some of these prescription parameters have been extensively studied, with some conflicting results. Although some level of resistance seems to matter, as well as number of sets and repetitions, the 'optimal' level and volume are unclear. Inducing or allowing pain based on tendon loading during exercises is todays consensus in the treatment of patellar and achilles tendinopathy using a pain-monitoring model. Although a number of shoulder studies report that pain either should be avoided or allowed, not one study ever examined the influence of pain allowance versus pain avoidance during a shoulder exercise program on patient outcome in terms of pain, physical function and disability.
The purpose of this project is to examine the effect of allowing pain versus avoiding pain based on tendon loading during an exercise regimen for patients with symptomatic rotator cuff (RC) tendinopathy. This will be accomplished in a Randomized Controlled Clinical Trial, comparing the effectiveness on patient reported and objective outcomes of a "pain allowing" and "pain avoiding" exercise program, performed for 26 weeks. Our hypothesis is that allowing pain based on tendon loading during exercises would result in a better outcome in pain and function measured on SPADI (the primary outcome) compared to avoiding pain in patients with RC tendinopathy.
Detailed description
Aim The purpose of this project is to examine the effect of allowing pain versus avoiding pain based on tendon loading during an exercise regimen for patients with symptomatic rotator cuff (RC) tendinopathy. This will be accomplished in a Randomized Controlled Clinical Trial, comparing the effectiveness on patient reported and objective outcomes of a "pain allowing" and "pain avoiding" exercise program, performed for 26 weeks.
Background Shoulder disorders are the third most common musculoskeletal disorder with a life-time prevalence in the general population of 30%. Shoulder disorders are often persistent and recurrent, with 54% of the patients reporting on-going symptoms after 3 years. RC tendinopathy is regarded as a common source of shoulder pain with prevalence estimated to be as high as 14% in the general working-age population. About 23% of the working population with shoulder problems are sick-listed, with a potential individual productivity loss.
RC tendinopathy is a tendon-related pain in the proximal lateral aspect of the upper arm with weakness, especially during active elevation and external rotation, and painful active range of motion. The pathoanatomic understanding is extended by classifying tissue irritability and specific impairments. Tissue irritability is meant to guide intensity of treatment, and identifying specific impairments guides specific tactics used for intervention. The prevalence of RC tendinopathy is highest in the supraspinatus and infraspinatus tendon.
Exercise therapy is widely regarded as an effective intervention for symptomatic RC tendinopathy for reducing pain and disability and improving function. It is well known that tendon collagen regains formation and tensile strength faster than unstressed collagen, and that it can take 12 month or longer before it reaches full maturity and strength. However, the prescription is diverse and the effectiveness of specific characteristics of exercise programs is unknown. Many contextual factors and prescription parameters, such as external resistance, training intensity and frequency, home versus supervised exercises, duration of the program, etc. have been described and are summarized in a systematic review. Some of these prescription parameters have been extensively studied, with some conflicting results. Although some level of resistance seems to matter, as well as a number of sets and repetitions, the 'optimal' level and volume are unclear. The existing studies offer some preliminary guidance in relation to the development and application of loading in exercise programs for RC tendinopathy, however there is a gap in literature with respect to allowing or avoiding pain during shoulder exercises. Inducing or allowing pain based on tendon loading during exercises is todays consensus in the treatment of patellar and achilles tendinopathy using a pain-monitoring model.
Although a number of shoulder studies report that pain either should be avoided or allowed, not one study ever examined the influence of pain allowance versus pain avoidance during a shoulder exercise program on patient outcome in terms of pain, physical function and disability.
Hypothesis Allowing pain based on tendon loading during exercises would result in a better outcome in pain and function measured on SPADI (the primary outcome) compared to avoiding pain in patients with RC tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Pain Allow | Experimental | Behavioral: Pain Allowing Program (PAllow)Pain is allowed up to 5/10 during exercises, monitored by NPRS. Depending on tissue irritability and other factors such as ROM, the exercises may be performed in an isometric way, or dynamic. |
| Pain Avoid | Active comparator | Behavioral: Pain Avoiding Program (PAvoid)Pain is not allowed during the exercises, and should be <2/10, monitored by NPRS. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 55 years
- Shoulder symptoms lasting for a minimum of 3 months
- Clinical diagnosis of rotator cuff (supraspinatus and/or infraspinatus) tendinopathy
- Clinical diagnosis verified by/ combined with ultrasound
Key exclusion criteria (11 listed)
- Patients are excluded if they have
- resting pain above 4/10 (NPRS)
- <90 degrees active elevation of the arm
- had a corticosteroid injection within the previous 12 weeks
- isolated subscapularis tendinopathy
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 |
|---|---|---|
| Pain Allowing Program (PAllow)Performing exercises considered to have a considerable supraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of > 40% MVC). | Behavioural | Pain Allow |
| Pain Avoiding Program (PAvoid)Performing exercises selected to have a minimal insupraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of <20% MVC). These unloading exercises are performed for 6 weeks. In the second part of the exercise protocol, the "loading" exercises are applied, however without pain. In case the patient still feels pain during the exercises in that period, the "unloading" exercises are continued. | Behavioural | Pain Avoid |
Primary outcome
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Time frame: 26-week
Self-reported measure of pain and function. The responses are indicated on a visual analogue scale where 0 = no pain/no difficulty and 10 = worst imaginable pain/so difficult it requires help. The items are summed and converted to a total score out of 100 where a high score indicates greater pain and disability in patients with shoulder disorders.
7 secondary outcomes
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Time frame: 52-week
Change from baseline in Disabilities Arm, Shoulder and Hand questionnaire (DASH)
Time frame: 26 and 52 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time frame: 26 and 52 weeks
Patient Acceptable Symptom State (PASS)
Time frame: 6, 26 and 52 weeks
Global Rating Scale (GRS)
Time frame: 6, 26 and 52 weeks
Change from baseline in Range-of-motion (ROM) in scapular plane elevation (standing) and in external (supine in 90° abduction)
Time frame: 26 and 52 weeks
Change from baseline in Isometric muscle strength (MVC) in shoulder elevation in scapular plane and external shoulder rotation
Time frame: 26 and 52 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 16 Jan 2025.
- Derived from this study: PubMed 38383459Kjaer BH, Cools AM, Johannsen FE, Trostrup J, Bieler T, Siersma V, Magnusson PS. To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial). Trials. 2024 Feb 21;25(1):135. doi: 10.1186/s13063-024-07973-6.
- Individual participant dataSharing planned: No
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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.
Birgitte H Kjær, Ph.D principal investigator
Bispebjerg and Frederiksberg Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Allowing Program (PAllow) and Pain Avoiding Program (PAvoid) in people with Rotator Cuff Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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 4 inclusion and 11 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 16 Jan 2025. 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 Denmark. 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?
Change from baseline in Shoulder Pain and Disability Index (SPADI) (time frame: 26-week). 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 NCT05124769, 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 16 Jan 2025.