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

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise therapy (exercising into pain)
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-65 years
  • shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
  • at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
  • resting pain should be at 2/10 maximum on VAS scale

Exclusion Criteria:

  • 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)
  • bilateral shoulder pain
  • evidence of adhesive capsulitis
  • history of shoulder surgery, fracture or dislocation (on the painful shoulder)
  • primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement
  • primary diagnosis of acromioclavicular pathology, shoulder instability (relocation and apprehension tests)
  • a radiologically confirmed fracture or presence of calcification larger than 5 mm (vertical distance)
  • presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness)
  • more than 4h of training in sport overhead shoulder activities per week

Sites / Locations

  • Physiotherapy private practices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Painful exercises

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Range of Movement (ROM) in internal rotation, external rotation, scaption
It is measured with the inclinometer. The unit of measure is degrees.
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
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.

Full Information

First Posted
October 25, 2019
Last Updated
July 27, 2023
Sponsor
Universiteit Antwerpen
Collaborators
University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04154345
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single-group study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Painful exercises
Arm Type
Experimental
Arm Description
The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale)
Intervention Type
Other
Intervention Name(s)
Exercise therapy (exercising into pain)
Intervention Description
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 Outcome Measure Information:
Title
Rate of adherence
Description
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.
Time Frame
measurement every week, change from baseline to 12 weeks
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
baseline,6 weeks, 12 weeks
Title
Fear of Pain Questionnaire (FPQ-9)
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Range of Movement (ROM) in internal rotation, external rotation, scaption
Description
It is measured with the inclinometer. The unit of measure is degrees.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Description
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Scapular dyskinesis
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Acromiohumeral Distance (AHD)
Description
It is measured with the Ultrasound machine at rest and at 60 degress of elevation in the scapular plane. (in millimiters)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Supraspinatus tendon thickness (STT)
Description
It is measured with the Ultrasound machine in the Crass position (in millimeters)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Occupation ratio
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks
Title
Global perceived effect (GPE)
Description
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.
Time Frame
1 week, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Struyf, Professor
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy private practices
City
Antwerp
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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