Clinical trial NCT04154345: Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study
Official title: Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University of Malaga
name: Rotterdam University of Applied Sciences
name: University of Southern Denmark
First posted: 2019-11-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-group study design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of adherence
timeFrame: measurement every week, change from baseline to 12 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: baseline,6 weeks, 12 weeks
measure: Fear of Pain Questionnaire (FPQ-9)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Range of Movement (ROM) in internal rotation, external rotation, scaption
timeFrame: baseline, 6 weeks, 12 weeks
measure: Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
timeFrame: baseline, 6 weeks, 12 weeks
measure: Scapular dyskinesis
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
measure: Acromiohumeral Distance (AHD)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Supraspinatus tendon thickness (STT)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Occupation ratio
timeFrame: baseline, 6 weeks, 12 weeks
measure: Global perceived effect (GPE)
timeFrame: 1 week, 6 weeks, 12 weeks
Locations:
city: Antwerp
country: Belgium
facility: Physiotherapy private practices
Study officials:
affiliation: Universiteit Antwerpen
name: Filip Struyf, Professor
role: PRINCIPAL_INVESTIGATOR
References: