Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study

NCT ID: NCT04154345

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2020-05-14

Brief Summary

The purpose of this study is to evaluate a) the feasibility of applying a painful exercise program in the treatment of subacromial shoulder pain and b) the time needed to collect clinical outcomes for a future randomized controlled trial.

Detailed Description

Exercise therapy is the first choice of treatment in the management of subacromial shoulder pain (SSP). Guidelines suggest active rehabilitation program for at least three months and existing research highlights the importance of progressive loaded exercise therapy at higher dosage. However, it is not clear which is the best type of exercise and if pain should be provoked during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim of the future randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program. Since the intervention consists in painful exercises, it is essential to test the rate of adherence in the intervention group (both during physiotherapist-led session and home-based exercises). Moreover, the practicability of clinical questionnaire via online survey will be tested and the time needed to collect clinical data will be calculated as well. Furthermore, feedback from physiotherapists and participants will be collected and analyzed.

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Painful exercises

The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale)

Group Type: EXPERIMENTAL

Exercise therapy (exercising into pain)

Intervention Type: OTHER

The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.

Interventions

Exercise therapy (exercising into pain)

The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years
• Shoulder pain for at least 3 months
• Pain in the antero-lateral shoulder region
• At least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc between 60° and 120°, external resistance test
• Resting pain should be at 2/10 maximum on verbal NRS scale
• All types of occupations were included: students, workers (including overhead workers or heavy duty workers), people on sick leave and retired people

Exclusion Criteria

• Bilateral shoulder pain
• Corticosteroid injections 6 weeks prior to the study
• Pregnancy, inability to understand spoken or written Dutch
• Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
• Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation)
• Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
• Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints)
• Primary diagnosis of acromioclavicular pathology, shoulder instability
• A radiologically confirmed fracture or presence of calcification larger than 5 mm
• Presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy)
• More than 4h of training in sport overhead shoulder activities per week

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: collaborator

Rotterdam University of Applied Sciences

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Filip Struyf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip Struyf, Professor

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Physiotherapy private practices

Antwerp, , Belgium

Countries

Belgium

References

Cavaggion C, Juul-Kristensen B, Luque-Suarez A, Voogt L, Wollants G, O Conaire E, Struyf F. Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. BMJ Open. 2023 Oct 6;13(10):e070698. doi: 10.1136/bmjopen-2022-070698.

Reference Type: RESULT

PMID: 37802620 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18/34/379

Identifier Type: -

Identifier Source: org_study_id