To determine the added value of myofeedback during scapulothoracic training at home in adults with subacromial shoulder pain.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures is the change self reported shoulder function measured
with the Shoulder Pain And Disability Index.
Secondary outcome
Patient characteristics; age, gender, duration of complaints, smoking history,
medication use.
- Relative muscle onset time
Relative muscle onset time will be measured using sEMG for the M. Trapezius
Descendens, M. Trapezius Ascendens, M. Serratus Anterior. The muscle onset time
will be measured relative to the M. Deltoid. Feedforward activity of the
scapulothoracic muscles will be defined as activation of the M. Trapezius
Ascendens or M. Serratus Anterior 100ms before to 50ms after M. Deltoid
Anterior, in mili-seconds.
- Maximum voluntary isometric contraction
Maximum voluntary isometric contraction will be measured using a MicroFet
(Hoggan Health Industries Inc, Utah, The United States of America) for the M.
Trapezius Descendens, M. Trapezius Ascendens, M. Serratus Anterior, and
M.Deltoid Anterior.
- Patients pereived satisfaction
We will use the Net Promotor Score to assess patient perceived satisfaction.
Patient perceived satisfaction wil only be measured during the follow-up
measurement.
- Adherence
Adherence to the exercise schedule will be tracked using a paper journal in all
three groups. At each session the participant will receive a journal from the
physical therapist performing the treatment. Then at the next session the
journal can be handed in.
Adherence will be expressed in percentages relative to the planned amount of
exercises, sets, and repetitions to be completed.
Background summary
Shoulder complaints, such as submacromial shoulder pain, occur frequently in
the general population.
Exercise therapy, often used as a treatment strategy to decrease complaints.
However, these specific exercises are difficult to perform, which contributes
to a suboptimal compliance especially with home exercises. To increase
compliance exercise therapy could be be augmentened using real-time
myofeedback. Real-time myofeedback can show a person if an exercise is being
performed correctly. With modern technology real-time biofeedback can be
provided at home to guide performance of the home exercise schedule. We intend
to investigate the added value of myofeedback during home exercise performance
in patients with subacromial shoulder pain
Study objective
To determine the added value of myofeedback during scapulothoracic training at
home in adults with subacromial shoulder pain.
Study design
prospective multicenter single-blinded randomized controlled trial
Intervention
The eight week intervention will start directly after the baseline measurement.
All treatments will be provided by one physical therapist. Each treatment
session will take one hour. During the first treatment session patient will
receive an explanation regarding the treatment and their first exercises.
Patients from all treatment groups will follow the same exercise schedule.
Group 1 will just regular training on how to perform the exercises and no
myofeedback training. Patients from group 2 and 3 will be trained using
myofeedback. Group 2 will receive myofeedback during the physical therapy
sessions, and group 3 will receive myofeedback during the physical therapye
sessions and during home exercise performance. Group 2 and 3 will be instructed
on how to perform myofeedback training. Previous studies have shown that it is
possible to improve scapulothoracic muscle control using myofeedback training
within one hour.
For all groups the intervention will be focused on training the scapuothoracic
muscles. Further procedures and details regarding the treatment are described
in chapter 4.1.
Study burden and risks
- Nature and extent of the burden:
The burden of the intervention is practically no greater than with the regular
treatment. Patients in all three groups wil perform the same exercises, however
the patients in group 2 and 3 will receive myofeedback during the physical
therapy session and myofeedback during the physical therapy sessions and during
home exercise performance respectively.
The burden of the intervention is 10 sessions of 60minutes (8 treatment
sessions, and 2 measurement sessions). Further during home exercise performance
patients in group 3 will be required to attach sEMG devices, start the app to
be able to use the myofeedback. This will require 1-2 minutes.
- Risks associated with the intervention
There is no added potential risk to the intervention compared to regular
physical therapy.
- Benefit
A possible benefit is that the intervention consists of regular exercises
augmented with a method of monitoring the quality of performance by using a
smartphone app and SEMG also known as myofeedback.
De Boelelaan 1105
Amsterdam 1081 HV
NL
De Boelelaan 1105
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. Age between 18 and 60 years;
2. Presence of scapular dyskinesis, defined as aymetrically moving scapulae during forward flexion or abduction.
3. Established diagnosis of SPS by physical therapist. diagnostic criteria voor subacromial shoulder pain:
i. Presence of pain during active shoulder elevation.
ii. Presence of pain during passive external rotation or isometric resistance against external rotation.
iii. Presence of at least two positive test, from the following tests: Hawkins-Kennedy test, isometric resistance external rotation, painful arc test.
Exclusion criteria
1. Presence of any of the following items:
a. Bilateral shoulder complaints.
b. Traumatic onset of shoulder complaints.
c. Duration of the shoulder complaints of more than nine months.
d. History of one or more surgeries on either shoulder.
e. Patient is on the waiting list for shoulder surgery.
f. Presence of systemic diseases(for example diabetes, rheumatoid arthritis, COPD).
g. Presence of neurological diseases (for example multiple slerosis, or other neurological diseases).
2. Presence of any of the following items in the physical examination
a. A limitation of the range of motion of the glenohumeral joint compared to the heterolateral glenohumeral joint.
b. Shoulder complaints which can be reproduced by cervical spine physical examination.
c. Shoulder complaints which can be reproduced by thoracic spine physical examination.
d. Positive horizontal adduction test.
e. Positive lag test for any of the following muscles; M. Supraspinatus, M. Infraspinatus, M. Subscapularis.
f. Positive tests for glenohumeral instability; apprenhension test, relocation test.
3. Inability to come to the physical therapy clinics for the duration of the intervention.
4. The use of paracetamol, or aspirine, or other non-steroidal anti-inflammatory drugs (ibuprofen, diclofenac, naproxen) during the treatment or refusing to discontinue the use of non-steroidal anti-inflammatory drugs during the study period;
5. Visus or cognitive limitations that inhibit the use of the sEMG devices. The potential participant needs to be able to clearly see, and interpret the screen of the sEMG devices/smartphones. For example blind patients will not be eligable for participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58382.042.17 |