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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Other: Exercise therapy (exercising into pain)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Physiotherapy private practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Supraspinatus tendon thickness (STT)	It is measured with the Ultrasound machine in the Crass position (in millimeters)	baseline, 6 weeks, 12 weeks
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
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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: University of Southern Denmark; University of Malaga; Rotterdam University of Applied Sciences
• Investigators: Principal Investigator: Filip Struyf, Professor, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): May 14, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Arthralgia; Shoulder Impingement Syndrome; Shoulder Pain
• Other Study ID Numbers: 18/34/379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No