Plain English Summary
Background and study aims
The shoulder injury known commonly as shoulder impingement is the most common disorder of the shoulder and accounts for the major part of neck-shoulder pain in north and mid-western Europe. It is the most common cause of work-related sickness absence, followed by back pain. Neither surgery nor physical treatment has yet found a solution to this problem, as two-thirds of patients are still looking for one or more subsequent treatments. Electromyography (EMG) biofeedback involves using sensors to provide feedback on muscle activity. The aim of this study is to find out whether EMG biofeedback-guided training reduces shoulder pain and improves shoulder function.
Who can participate?
Patients aged 18 to 65 with shoulder impingement
What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. All participants are instructed to perform the same exercises with 2x10 repetitions once a day over 8 weeks. The intervention group receive biofeedback on a computer screen from the muscles the exercises are focused on, while the control group do not receive this biofeedback. Shoulder pain and function are assessed using questionnaires at the start and end of the study.
What are the possible benefits and risks of participating?
The benefits of participation are access to free supervised shoulder muscle exercise training as well as a clinical examination of the shoulders. Participation does not involve any risks for the patients.
Where is the study run from?
University of Southern Denmark (Denmark)
When is the study starting and how long is it expected to run for?
April 2009 to July 2012
Who is funding the study?
University of Southern Denmark (Denmark)
Who is the main contact?
1. Prof. Karen Søgaard
2. Prof. Birgit Juul-Kristensen
Study website
Contact information
Type
Scientific
Contact name
Prof Karen Søgaard
ORCID ID
http://orcid.org/0000-0003-3968-6364
Contact details
Dep of Sport Sciences and Clinical Biomechanics.
Dep of Clinical Research
University of Southern Denmark
Odense
Campusvej 55
Odense
5230
Denmark
Type
Scientific
Contact name
Prof Birgit Juul-Kristensen
ORCID ID
Contact details
Dep of Sport Sciences and Clinical Biomechanics.
University of Southern Denmark
Odense
Campusvej 55
Odense
5230
Denmark
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Danish Association of Rheumatism R62 A985
Study information
Scientific title
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
Acronym
BIONEX
Study hypothesis
In impingement patients, an eight-week biofeedback-guided intervention exercise group with EMG feedback will compared to a control group receiving the same exercises but without EMG biofeedback:
1. Decrease more in shoulder pain measured via self-reported pain (NRS)
2. Increase level of shoulder function (measured via self-reported level of function scores, DASH and OSS)
3. Increase muscular activity in lower trapezius (LT) and serratus anterior (SA), as well as decrease muscle activity in upper trapezius (UT), thereby also decreasing the ratios UT/LT & UT/SA
Ethics approval(s)
Regional Ethical Committee of Southern Denmark, 09/11/2009, Project ID: S-20090090
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Subacromial impingement syndrome (SIS)
Intervention
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.
Intervention type
Other
Primary outcome measure
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.
Secondary outcome measures
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.
Overall study start date
01/04/2009
Overall study end date
11/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
A total of 40 patients with 20 participants in each group
Total final enrolment
49
Participant 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
Recruitment start date
01/09/2010
Recruitment end date
03/05/2012
Locations
Countries of recruitment
Denmark
Study participating centre
University of Southern Denmark
Dept of Sport Sciences and Clinical Biomechanics
Campusvej 55
Odense
5230
Denmark
Sponsor information
Organisation
Forsknings- og Innovationsstyrelsen (National Research Council)
Sponsor details
Bredgade 40
1260 København K
1260 København K
1260
Denmark
+45 (0)35 44 62 00
ufm@ufm.dk
Sponsor type
Government
Website
https://ufm.dk/forskning-og-innovation/tilskud-til-forskning-og-innovation
Organisation
Gigtforeningen (Danish Association of Rheumatism)
Sponsor details
Gentoftegade 118
Gentofte
2820
Denmark
+45 (0)39 77 80 00
info@gigtforeningen.dk
Sponsor type
Charity
Website
www.gigtforeningen.dk/om-os/kontakt/
Organisation
Region Syddanmark
Sponsor details
Region Syddanmark
Regionshuset
Damhaven 12
7100 Vejle
Vejle
7100
Denmark
+45 (0)76 63 10 00
kontakt@rsyd.dk
Sponsor type
Government
Website
Organisation
Danish Ministry of Higher Education and Science
Sponsor details
Haraldsgade 53
Copenhagen
2100
Denmark
-
abc@123.com
Sponsor type
Government
Website
http://ufm.dk/en?set_language=en&cl=en
ROR
Funders
Funder type
University/education
Funder name
Syddansk Universitet
Alternative name(s)
University of Southern Denmark, SDU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Denmark
Results and Publications
Publication and dissemination plan
Planned publication of the results in a high-impact peer-reviewed journal. First publication expected to be submitted March 2018.
Intention to publish date
01/03/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available.
IPD sharing plan summary
Not expected to be made available
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Statistical Analysis Plan | No | No | |||
Results article | 01/10/2019 | 23/04/2021 | Yes | No |