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

Not Applicable

Completed

Conditions: Shoulder Impingement Syndrome

Registration Number: NCT04154345

Lead Sponsor: Universiteit Antwerpen

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of Adherence (Physiotherapy Session)	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
Rate of Adherence (Adherence Home Exercises)	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.
Shoulder Pain and Disability Index (SPADI)	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 Outcome Measures

Name	Time	Method
MVC in Scaption	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.
Fear-Avoidance Beliefs Questionnaire (FABQ-PA)	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
Fear-Avoidance Beliefs Questionnaire (FABQ-W)	value at baseline minus value at 12 weeks	Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs
Fear of Pain Questionnaire (FPQ-9)	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.
Passive Range of Motion (ROM) in External Rotation	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Passive ROM in Internal Rotation	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Passive ROM in Scaption	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Active ROM in External Rotation	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Active ROM in Internal Rotation	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Active ROM in Scaption	value at 12 weeks minus baseline	It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Maximum Voluntary Contraction (MVC) in External Rotation	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.
MVC in Internal Rotation	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.