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

NCT04154345 | Completed Results

• 1 other identifier: 18/34/379
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Outcome Measures

Primary Outcomes (3)

• Rate of Adherence (Physiotherapy Session)

  It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions

  measurement every session, final measure at the end of 12 weeks

• Rate of Adherence (Adherence Home Exercises)

  It is analysed in terms of adherence to home exercises. Good level of adherence is achieved when patients completed at least 22 of 27 (81%) sessions. One session of non-supervised (home) exercise was considered completed when at least 80% of the total amount of sets and repetitions were executed as prescribed by the physiotherapist.

  measurement every home exercise session, final measure at the end of 12 weeks

• Shoulder Pain and Disability Index (SPADI)

  There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.

  value at baseline minus value at 12 weeks

Secondary Outcomes (12)

• Fear-Avoidance Beliefs Questionnaire (FABQ-PA)

  value at baseline minus value at 12 weeks

• Fear-Avoidance Beliefs Questionnaire (FABQ-W)

  value at baseline minus value at 12 weeks

• Fear of Pain Questionnaire (FPQ-9)

  value at baseline minus value at 12 weeks

• Passive Range of Motion (ROM) in External Rotation

  value at 12 weeks minus baseline

• Passive ROM in Internal Rotation

  value at 12 weeks minus baseline

Other Outcomes (4)

• Acromiohumeral Distance (AHD)

  value at baseline minus value at 12 weeks

• Supraspinatus Tendon Thickness (STT)

  value at baseline minus value at 12 weeks

• Global Perceived Effect - Recovery (GPE-R)

  value at baseline minus value at 12 weeks

Study Arms (1)

Painful exercises

EXPERIMENTAL

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

Other: Exercise therapy (exercising into pain)

Interventions

Exercise therapy (exercising into pain) 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.

Painful exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University of Malaga: collaborator
• Rotterdam University of Applied Sciences: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Physiotherapy private practices

Antwerp, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37802620 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Limitations and Caveats

Limitations of the feasibility study are specified in the published article

Results Point of Contact

• Title: Prof. Filip Struyf
• Organization: University of Antwerp

filip.struyf@uantwerpen.be

32652783

Study Officials

• Filip Struyf, Professor

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective single-group study design

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 6, 2019
• Study Start: November 28, 2019
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)