PAin During Shoulder Exercise

Rotator Cuff Tendinopathy Clinical Trial

— 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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05124769
• Other study ID #: BispebjergH_PASE_BKjaer
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Behavioral:
• Pain Allowing Program (PAllow)
Performing exercises considered to have a considerable supraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of > 40% MVC).
• 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen NV	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Pressure Pain Threshold (PPT)	Objective measure	26 weeks
Other	Quantitative and qualitative ultrasound (US) evaluation	Objective measure	Baseline, 26 and 52 weeks
Other	Workability Index (WAI)	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').	Baseline, 26 and 52 weeks
Other	Sport participation	Sport participation and return to sport	Baseline, 26 and 52 weeks
Primary	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.	26-week
Secondary	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.	52-week
Secondary	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.	26 and 52 weeks
Secondary	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.	26 and 52 weeks
Secondary	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".	6, 26 and 52 weeks
Secondary	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.	6, 26 and 52 weeks
Secondary	Change from baseline in Range-of-motion (ROM) in scapular plane elevation (standing) and in external (supine in 90° abduction)	Objective measure	26 and 52 weeks
Secondary	Change from baseline in Isometric muscle strength (MVC) in shoulder elevation in scapular plane and external shoulder rotation	Objective measure	26 and 52 weeks