PAin During Shoulder Exercise (PASE)
Primary Purpose
Rotator Cuff Tendinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pain Allowing Program (PAllow)
Pain Avoiding Program (PAvoid)
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring rotator cuff, tendinopathy, tendinosis, shoulder, overuse injuries
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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.
Sites / Locations
- Bispebjerg and Frederiksberg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pain Allow
Pain Avoid
Arm Description
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 is not allowed during the exercises, and should be <2/10, monitored by NPRS.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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".
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.
Change from baseline in Range-of-motion (ROM) in scapular plane elevation (standing) and in external (supine in 90° abduction)
Objective measure
Change from baseline in Isometric muscle strength (MVC) in shoulder elevation in scapular plane and external shoulder rotation
Objective measure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05124769
Brief Title
PAin During Shoulder Exercise
Acronym
PASE
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?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
November 10, 2024 (Anticipated)
Study Completion Date
November 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy
Keywords
rotator cuff, tendinopathy, tendinosis, shoulder, overuse injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with parallel assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Double (investigator, outcome assessor)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain Allow
Arm Type
Experimental
Arm Description
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.
Arm Title
Pain Avoid
Arm Type
Active Comparator
Arm Description
Pain is not allowed during the exercises, and should be <2/10, monitored by NPRS.
Intervention Type
Behavioral
Intervention Name(s)
Pain Allowing Program (PAllow)
Intervention Description
Performing exercises considered to have a considerable supraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of > 40% MVC).
Intervention Type
Behavioral
Intervention Name(s)
Pain Avoiding Program (PAvoid)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
26-week
Secondary Outcome Measure Information:
Title
Change from baseline in Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
52-week
Title
Change from baseline in Disabilities Arm, Shoulder and Hand questionnaire (DASH)
Description
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.
Time Frame
26 and 52 weeks
Title
Change from baseline in Numeric Pain Rating Scale (NPRS)
Description
Self-reported measure of pain. The score ranges from 0 to 10 where 0 equals no pain and 10 equals the most severe pain.
Time Frame
26 and 52 weeks
Title
Patient Acceptable Symptom State (PASS)
Description
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".
Time Frame
6, 26 and 52 weeks
Title
Global Rating Scale (GRS)
Description
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.
Time Frame
6, 26 and 52 weeks
Title
Change from baseline in Range-of-motion (ROM) in scapular plane elevation (standing) and in external (supine in 90° abduction)
Description
Objective measure
Time Frame
26 and 52 weeks
Title
Change from baseline in Isometric muscle strength (MVC) in shoulder elevation in scapular plane and external shoulder rotation
Description
Objective measure
Time Frame
26 and 52 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in Pressure Pain Threshold (PPT)
Description
Objective measure
Time Frame
26 weeks
Title
Quantitative and qualitative ultrasound (US) evaluation
Description
Objective measure
Time Frame
Baseline, 26 and 52 weeks
Title
Workability Index (WAI)
Description
Working ability A single item question concerning current work ability compared with the lifetime best, with a possible score 0 ('completely unable to work') to 10 ('work ability at its best').
Time Frame
Baseline, 26 and 52 weeks
Title
Sport participation
Description
Sport participation and return to sport
Time Frame
Baseline, 26 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bispebjerg and Frederiksberg Hospitals
Phone
+45 21490805
Email
birgitte.hougs.kjaer@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte H Kjær, Ph.D
Organizational Affiliation
Bispebjerg and Frederiksberg Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospital
City
Copenhagen NV
State/Province
Danmark
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kjær
Phone
21490805
Email
birgitte.hougs.kjaer@regionh.dk
First Name & Middle Initial & Last Name & Degree
Magnusson
Email
p.magnusson@sund.ku.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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