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

Shoulder Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154345
• Other study ID #: 18/34/379
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: May 14, 2020

Study information

• Verified date: July 2023
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	Physiotherapy private practices	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Rotterdam University of Applied Sciences, University of Malaga, University of Southern Denmark

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acromiohumeral Distance (AHD)	It is measured with the Ultrasound machine at rest and at 60 degress of elevation in the scapular plane. (in millimiters)	baseline, 6 weeks, 12 weeks
Other	Supraspinatus tendon thickness (STT)	It is measured with the Ultrasound machine in the Crass position (in millimeters)	baseline, 6 weeks, 12 weeks
Other	Occupation ratio	AHD and STT will be combined in the occupation ratio to report how much space is occupied in the subacromial space, represented by the AHD, by the supraspinatus tendon. It is in percentage.	baseline, 6 weeks, 12 weeks
Other	Global perceived effect (GPE)	It is measured on a 7-Likert Scale, ranging from 1 (way much better) to 7 (way much worse); higher scores mean worst global perceived effect.	1 week, 6 weeks, 12 weeks
Primary	Rate of adherence	It is analysed in terms of attendance to the physiotherapist-led sessions and adherence to the home-exercise protocol. Good level of adherence is defined by: attendance of 7/9 (78%) of physiotherapist led-sessions and 22/27 (81%) days of home-exercises completed.	measurement every week, change from baseline to 12 weeks
Primary	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.	change from baseline to 12 weeks
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.	baseline,6 weeks, 12 weeks
Secondary	Fear of Pain Questionnaire (FPQ-9)	It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45; higher scores mean more fear and anxiety associated with pain.	baseline, 6 weeks, 12 weeks
Secondary	Range of Movement (ROM) in internal rotation, external rotation, scaption	It is measured with the inclinometer. The unit of measure is degrees.	baseline, 6 weeks, 12 weeks
Secondary	Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption	It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.	baseline, 6 weeks, 12 weeks
Secondary	Scapular dyskinesis	It is measured with visual observation during the following clinical tests: 1) scapular dyskinesis at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement; 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.	baseline, 6 weeks, 12 weeks