PAin During Shoulder Exercise

NCT05124769 | Completed

• 1 other identifier: BispebjergH_PASE_BKjaer
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinopathy

Keywords

rotator cuff; tendinopathy; tendinosis; shoulder; overuse injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in Shoulder Pain and Disability Index (SPADI)

  52-week

• Change from baseline in Disabilities Arm, Shoulder and Hand questionnaire (DASH)

  26 and 52 weeks

• Change from baseline in Numeric Pain Rating Scale (NPRS)

  26 and 52 weeks

• Patient Acceptable Symptom State (PASS)

  6, 26 and 52 weeks

• Global Rating Scale (GRS)

  6, 26 and 52 weeks

Other Outcomes (4)

• Change from baseline in Pressure Pain Threshold (PPT)

  26 weeks

• Quantitative and qualitative ultrasound (US) evaluation

  Baseline, 26 and 52 weeks

• Workability Index (WAI)

  Baseline, 26 and 52 weeks

Study Arms (2)

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.

Behavioral: Pain Allowing Program (PAllow)

Pain Avoid

ACTIVE COMPARATOR

Pain is not allowed during the exercises, and should be \<2/10, monitored by NPRS.

Behavioral: Pain Avoiding Program (PAvoid)

Interventions

Pain Allowing Program (PAllow) BEHAVIORAL

Performing exercises considered to have a considerable supraspinatus/ infraspinatus tendon/muscle load (EMG muscle activity of \> 40% MVC).

Pain Allow

Pain Avoiding Program (PAvoid) BEHAVIORAL

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.

Pain Avoid

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

Copenhagen NV, Danmark, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38383459 DERIVED

MeSH Terms

Conditions

Tendinopathy; Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Sprains and Strains

Study Officials

• Birgitte H Kjær, Ph.D

  Bispebjerg and Frederiksberg Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (investigator, outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial with parallel assignment

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: January 11, 2022
• Primary Completion: June 30, 2024
• Study Completion: January 13, 2025
• Last Updated: January 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)