PAin During Shoulder Exercise

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

Interventions

BEHAVIORAL

Pain Allowing Program (PAllow)

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

BEHAVIORAL

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.

Sponsors & Collaborators

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Birgitte H Kjær, Ph.D · Bispebjerg and Frederiksberg Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-11

Primary Completion

2024-06-30

Completion

2025-01-13

Countries

• Denmark