This study aims to assess if actively training adductor co-contraction in patients with SAPS is clinically effective. A specific therapy protocol is already in practice in the physical therapy department of the Leiden University Medical Center (LUMC…
ID
Source
Brief title
Condition
- Other condition
- Tendon, ligament and cartilage disorders
Synonym
Health condition
Chronische schouderpijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcomes are pain (Visual Analogue Scale), arm-shoulder function
(Constant score).
Secondary outcome
Bio-physical-social health (RAND-36, Shoulder Rating Questionnaire) and,
self-reported quality of life (Western Ontario Rotator Cuff index).
Co-contraction as assessed with EMG will be expressed using the Activation
Ratio ([AR]; range [-1 to1]), indicating the task-related amount of antagonist
activation relative to the same muscle*s degree of agonistic activation,
corresponding to 1 in case of pure agonist muscle activation and -1 in case of
pure antagonistic activation. Furthermore, movement complexity and
proprioception, factors that potentially associate with the clinical course of
SAPS will be assessed using electromagnetic motion analysis (Flock of Birds,
FoB). Lastly, we will evaluate the content of care provided and compliance of
the patients by asking the patients to fill out a registration form on the
frequency, duration and content of treatment.
Background summary
In patients with Subacromial Pain Syndrome (SAPS), there is a potentially
treatable muscle activation imbalance between arm abductors and arm adductors,
that leads to the typical overloading of subacromial tissues during abduction.
This muscular imbalance may result from declines in proprioception and/or
movement complexity and can be restored with enhanced co-contraction. It has
been recently shown that compared to age-matched controls, patients with SAPS
have decreased co-contraction levels of arm adductors (humeral depressors)
during abduction. Furthermore, it has been shown that an increase in adductor
co-contraction associates with a favourable clinical course in patients with
SAPS. Based on these findings and clinical observations, we propose that active
enhancement of adductor co-contraction in patients with SAPS might be a
beneficial treatment option.
Study objective
This study aims to assess if actively training adductor co-contraction in
patients with SAPS is clinically effective. A specific therapy protocol is
already in practice in the physical therapy department of the Leiden University
Medical Center (LUMC). Secondly, we want to investigate if this clinical
improvement is associated with increased co-contraction levels by
electromyographic (EMG) assessment. Additionally, kinematic analysis will be
performed in order to evaluate factors also associated with clinical outcome,
including movement complexity and proprioception.
Study design
Randomised controlled trial with two study groups comparing the control group
(standard care) with the inverventiongroup (standard care plus a specific
physical therapy protocol aimed at enhancing adductor co-contraction).Clinical
effect (questionnaires) and co-contraction of the Latissimus Dorsi, Teres
Major, Pectoralis Major and/or Deltoid Muscle (electromyography, EMG) will be
quantified in three study-related visits. The intervention period lasts 3
months and the effects will be monitored after 1 year.
Intervention
The patients will be randomly allocated to either the control (n=40)
intervention group (n=40). All patients will receive standard-care treatment
(information provided by the treating physician, relative rest and an
ultrasound-guided subacromial corticosteroid injection). Additionally, the
intervention group will receive specific *Scooping Therapy* treatment in the
LUMC. Scooping Therapy consists of a standardized physical therapy program with
specific focus on active contribution of humeral-head depressors during
abduction.
Study burden and risks
The intervention concerns specific scooping exercise therapy delivered by
trained physical therapists from the LUMC according to a standardized protocol.
There are no risks for participants. This study is embedded in standard
treatment of SAPS and consists of three study-related visits to the
Laboratorium for Kinematics and Neuromechanics. The assessments take
approximately 2.5 hours in total. Completing the questionnaires, EMG- and FoB
measurements may be inconvenient and burdensome. Data will be analysed
according to the intention-to-treat principle.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to participate in this study, a subject must meet all of the following
criteria
- Chronic shoulder pain (>3months).
- Suspicion of subacromial origin of pain (e.g. combination of positive painful
arc test, Hawkins-Kennedy test and empty can test).
- Presence of conventional ultrasonography.
- Presence of conventional radiographs.
Exclusion criteria
- Younger than 18 years of age;
- History of fracture or dislocation of the shoulder;
- History of surgery around the shoulder;
- Clinical and/or radiographic signs of comorbidities or alternative diagnoses
of the affected shoulder (glenohumeral instability,
glenohumeral/acromioclavicular osteoarthritis or arthritis, rheumatic disorder,
history of trauma of the affected shoulder, capsulitis adhesiva, full thickness
rotator cuff rupture, cervical radiculopathy, plexus lesions).
- Tendinitis calcarea >3mm, although part of saps; requires different treatment
methods.
- Symptomatic cervical spine pathology;
- Neoplasms;
- Pregnancy;
- Cognitive impairment;
- Electronic implants (e.g. Implantable Cardioverter Defibrillator, pacemaker);
- Insufficient Dutch language skills;
- Refusing physical therapy treatment (for example, due to the absence of
reimbursement);
- Refusing ultrasound guided subacromial corticosteroid injection;
- No informed consent.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL71012.058.19 |