Skip to main content
OpenTrials
Completed

NCT Number: NCT04154345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy private practices

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of Adherence (Physiotherapy Session)

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

    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

  2. Rate of Adherence (Adherence Home Exercises)

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

    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.

  3. Shoulder Pain and Disability Index (SPADI)

    Time frame: value at baseline minus value at 12 weeks

    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.

Secondary outcomes

  1. Fear-Avoidance Beliefs Questionnaire (FABQ-PA)

    Time frame: value at baseline minus value at 12 weeks

    Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs

  2. Fear-Avoidance Beliefs Questionnaire (FABQ-W)

    Time frame: value at baseline minus value at 12 weeks

    Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs

  3. Fear of Pain Questionnaire (FPQ-9)

    Time frame: value at baseline minus value at 12 weeks

    It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45.

    Higher scores indicate more fear and anxiety associated with pain.

  4. Passive Range of Motion (ROM) in External Rotation

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  5. Passive ROM in Internal Rotation

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  6. Passive ROM in Scaption

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  7. Active ROM in External Rotation

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  8. Active ROM in Internal Rotation

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  9. Active ROM in Scaption

    Time frame: value at 12 weeks minus baseline

    It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

  10. Maximum Voluntary Contraction (MVC) in External Rotation

    Time frame: value at 12 weeks minus value at baseline

    It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

  11. MVC in Internal Rotation

    Time frame: values at 12 weeks minus values at baseline

    It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

  12. MVC in Scaption

    Time frame: values at 12 weeks minus baseline

    It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

Other outcomes

  1. Acromiohumeral Distance (AHD)

    Time frame: value at baseline minus value at 12 weeks

    It is measured with the Ultrasound machine at rest and at 60 degrees of elevation in the scapular plane. (in millimeters)

  2. Supraspinatus Tendon Thickness (STT)

    Time frame: value at baseline minus value at 12 weeks

    It is measured with the Ultrasound machine in the Crass position (in millimeters)

  3. Global Perceived Effect - Recovery (GPE-R)

    Time frame: value at baseline minus value at 12 weeks

    The Global Perceived Effect (GPE) of recovery was measured after 1 week of treatment, at 6 week and at 12 weeks with the question: "To what extent do you feel recovered compared to the beginning of the treatment?" (from 1=very much better to 7=very much worse). Higher scores indicate worse outcome.

  4. Global Perceived Effect - Satisfaction (GPE-S)

    Time frame: value at baseline minus value at 12 weeks

    The Global Perceived Effect (GPE) of satisfaction was measured after 1 week of treatment, at 6 week and at 12 weeks with the question "To what extend are you satisfied about your treatment?" (from 1=absolutely satisfied to 7=absolutely dissatisfied). Higher scores indicate worse outcome.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Rotterdam University of Applied Sciences
  • University of Malaga
  • University of Southern Denmark

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.