The objective of the study is to find answers on the research question: does activation of descending nociceptive inhibitory mechanisms via central pain medication lead to changes in kinematic and/or muscular changes in shoulder function?
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) differences in three-dimensional movement parameters of the scapula before
and after pain medication and placebo. 2) differences in muscular activity
before and after pain medication and placebo.
Secondary outcome
Not applicable
Background summary
The current body of knowledge of the interaction between pain and movement
shows a bidirectional relationship: pain influences movement and movement
disorders influence the arising of pain. Knowledge of these 'pain-motor
interactions' is of importance for physical therapy treatments of patients with
musculoskeletal pain of which patients with shoulder pain are a subgroup. The
majority of scholars in the field of shoulder pain treatment and research say
that shoulder pain relates to movement disturbances of the scapula. This
'scapular dyskinesis' leads to the ignition of shoulder pain and limitations in
daily activities. Physical exercises are recommended and have shown to be
effective for pain reduction and movement disturbances.
Study objective
The objective of the study is to find answers on the research question: does
activation of descending nociceptive inhibitory mechanisms via central pain
medication lead to changes in kinematic and/or muscular changes in shoulder
function?
Study design
Randomized Clinical Trial, with a cross-over design.
Intervention
Before the measurements are taken demographic data as 'age', 'sex', 'work and
marital status', 'normal physical activities (sport and hobby's) are noted.
Shoulder pain intensity and associated limitations in daily functioning are
measured with a VAS (visual analogue scale) and a DASH (disabilities of the
arm, shoulder and hand).
Scapular movement and muscular activity in scapular musculature is measured
(with optotrack for scapular movement and EMG for muscular activity) during arm
abduction of the painful shoulder.
Measurements are taken in a cross-over design (1 time before medication/placebo
and 1 time after). For inducing central pain inhibition Oxynorm (5mg) is used.
Study burden and risks
Participants with shoulder pain are tested twice on different days (time
interval between 2 - 7 days) in a cross-over design. At both times a physical
examination of the shoulder is carried out and two questionnaires are filled
in. Then optotrackmarkers (6) and EMG electrodes (6) are attached on the
arm/shoulder of the participant. During the experiment the participants move
the arm three times in abduction-elevation. There are no risks attached on the
measurement protocol.
Total time for the testprocedure is: 2 hours (on each of the two days).
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Minimal age 18 years.
- Painfull arc in abduction- and/or elevation of the shoulder/arm.
- Minimal 3 positive results out of of the 4 following clinical tests to detect subacromial impingement are positive: Hawkins-Kennedy test, Neer test, Jobe test, Apprehansion test.
Exclusion criteria
Shoulder pain due to:
- trauma.
- inflammatory disease.
- degenerative changes.
- cervical radiculopathy.
Movement problems due to:
- Parkinson, Stroke, MS et cetera.
- shoulder stiffness (e.g. frozen shoulder, active movement of minimal 160 degrees of shoulder/arm elevation should be possible).
Pain treatment:
- corticosteroid injection < 3 weeks before testing.
- painkillers < 48 hours before testing.
- use of opiat medication
Other:
- pregnancy.
- allergic for asperin
- allergic for natrium benzoaat
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 |
|---|---|
| Other | Eudract: 2014-002538-30 |
| CCMO | NL47213.078.14 |