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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
ISRCTN10718603 |
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Date of registration:
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24/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of EMG biofeedback: a randomized controlled clinical trial in patients with shoulder pain
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Scientific title:
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The effect of eight weeks of training with and without EMG biofeedback, on pain and muscle function in patients with shoulder impingement: a randomized controlled clinical trial |
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Date of first enrolment:
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01/09/2010 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN10718603 |
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Study type:
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Interventional |
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Study design:
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Single-centre randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Karen
Søgaard |
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Address:
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Dep of Sport Sciences and Clinical Biomechanics.
Dep of Clinical Research
University of Southern Denmark, Odense
Campusvej 55
5230
Odense
Denmark |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. At least 30 days with pain/discomfort in the shoulder/neck region within the last year
2. At least two or more positive impingement tests based on the Jobe, Neer; Hawkins and Apprehensions tests
3. 18-65 years old
Exclusion criteria:
1. Equal or more than 8 in pain/discomfort - measured with Numeric Rating Scale from 0-10 (NRS) - throughout the last 24 hours (on test day)
2. Had more than three regions with pain, for at least 30 days during the last 12 months
3. Had a history of severe shoulder-neck pathology/trauma and/or orthopaedic surgery and/or received anti-inflammatory injections within the last 3 months
4. If they were pregnant (EMG precaution)
5. Any documented life threatening diseases
6. Cardiovascular diseases
7. Rheumatoid arthritis
8. Generalized pain
9. Adverse psychosocial conditions
10. Signs for cervical radiculopathy, i.e. Spurling A test, Involved Cervical Rotation test (less than 60?), Neck Distraction test
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Subacromial impingement syndrome (SIS)
Musculoskeletal Diseases
Impingement syndrome of shoulder
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Intervention(s)
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The intervention program was divided into two periods. The first period was a three-week phase with instruction in different exercises with focus on LT and SA activation. The purpose was to (re)activate the muscles and thereby increase the subjects’ awareness of those muscles’ position and function. The purpose of the second period (a five-week phase) was to transfer the awareness gained through the first phase into the performance of more functionally complicated exercises. Here, coactivation of the LT and SA in dynamic movements was emphasised in order to master exercises and succeed to the next. Standardised progression regimes according to the subjects’ individual pain levels were developed and followed in both first and second period. The subjects were supervised once a week by the same physiotherapist and instructed how to progress and to do the exercises with 2x10 repetitions once a day during the eight weeks of intervention. Also, stretching exercises and ergonomic instructions were given.
All participants in this study received the same exercises. The only difference between the interventions applied to the intervention and control group was the provision of online visual feedback of muscle activity, shown horizontally (from left to right) on a monitor (biofeedback) visible for both the subject and instructing physiotherapist in the intervention group. The no-EMG control group only received instructions from the physiotherapist based on quality of exercise and if needed, manual/tactile corrections.
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Primary Outcome(s)
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Self-reported pain assessed using a numeric rating scale (NRS) as part of a questionnaire filled out before commencing physical testing at baseline and follow-up (week 0 and 8):
1. “Pain now” measured on NRS (0-10) at baseline and follow-up testing
2. “Pain within the last 24 hours” measured on NRS (0-9) at baseline and follow-up testing
3. “Pain within the last 7 days” measured on NRS (0-9) at baseline and follow-up testing
Furthermore, the subjects were asked to register their daily pain level in a diary throughout the eight weeks of home exercise. This diary was used to measure the daily pain development (NRS 0-10) and then to measure compliance, as the subjects would register the execution of their home exercises.
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Secondary Outcome(s)
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1. Self-reported shoulder-scores obtained from questionnaires at baseline and follow-up:
1.1. Disability of the Arm, Shoulder and Hand questionnaire (DASH)
1.2. The Oxford Shoulder Score (OSS)
2. Muscle activity measured by surface electromyography (sEMG) signals from three muscles: upper trapezius (UT), lower trapezius (LT) and serratus anterior (SA). The measurements were carried out according to a standardized experimental procedure, containing a voluntary movement task (described in experimental procedure). During arm elevation, mean relative activity (percentage of maximal voluntary electric activity, %MVE) was measured and muscle activation ratios between the muscles (UT/LT and UT/SA) were calculated. Measured at baseline and follow-up.
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Secondary ID(s)
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Danish Association of Rheumatism R62 A985
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Source(s) of Monetary Support
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Syddansk Universitet
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Ethics review
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Status:
Approval date:
Contact:
Regional Ethical Committee of Southern Denmark, 09/11/2009, Project ID: S-20090090
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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11/07/2012 |
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URL:
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