Our primary objective is to test the hypothesis that there is an association between high CPS at baseline and a low relative effect from subacromial anaesthetics (as compared to subacromial placebo). The increased pain perceived by these patients…
ID
Source
Brief title
Condition
- Other condition
- Synovial and bursal disorders
Synonym
Health condition
Chronische pijn in de schouder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study paramaters are: 1) the effect of subacromial injections on pain
at rest and during abduction assessed with a visual analogue scale (VAS), 2)
CPS assessed with bilateral Quantitative Sensory Testing (QST).
Secondary outcome
Secondary study parameters (determinants) are two anchor questions for pain,
assessment of succesful blinded allocation, shoulder muscle activation ratios
(ARs), findings from ultrasonography, questionnaires and demographics and will
be used to assess factors that are associated with pain in SAPS.
Background summary
The Subacromial Pain Syndrome (SAPS), also known as the Subacromial Impingement
Syndrome, is the most common shoulder disorder in primary health care,
characterized by disabling chronic shoulder pain. With regards to the
pathophysiology, several mechanisms have been suggested that generally share a
focus on (peri)articular shoulder changes, e.g. the classic extrinsic,
intrinsic and the dynamic mechanisms. Nevertheless, there is still a group of
patients with symptoms that cannot be explained by (peri)articular changes
alone. We hypothesize that the explanation for the discrepancy between observed
(peri)articular changes and the experienced pain in patients with SAPS, may be
found in the processing of pain, i.e. central pain sensitisation (CPS).
Study objective
Our primary objective is to test the hypothesis that there is an association
between high CPS at baseline and a low relative effect from subacromial
anaesthetics (as compared to subacromial placebo). The increased pain
perceived by these patients would rather originate from altered processing of
pain, than from (peri)articular changes (alone).
Study design
A placebo controlled, blinded (patient, researcher, radiologist), randomised
cross-over trial with two interventions (subacromial anaesthetics, placebo)
that are uniform within sequence and within periods.
Intervention
In a randomised sequence, participants will receive two US-guided subacromial
injections: one with anaesthetics (5cc lidocaine 1%, using a 50 mm 21 gauge
needle) and one with a placebo (5cc NaCl 0.90%). There is a wash-out period of
1 week between both procedures.
Study burden and risks
Patients will be subjected to an US-guided subacromial injection with lidocaine
and placebo. Such an injection (lidocaine) is often given in standard care for
both diagnostic and therapeutic purposes. In 1-10% of lidocaine injections,
paraesthesia, dizziness, bradycardia, hypotension, hypertension, nausea and
vomiting are reported. Fulfilling three quality-of-life questionnaires can be
burdensome and time consuming. Finally, QST measurements may be experienced as
inconvenient. At completion of all study procedures, participants will receive
a gift voucher of 40euros, in case of earlier drop-out 20 euros.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Chronic shoulder pain (>3 months)
- Unilateral shoulder pain
- Suspicion of subacromial origin of pain (e.g. positive painful arc test, Hawkins-Kennedy test, empty can test)
- Presence of conventional ultrasonography
- Presence of conventional radiographs
Exclusion criteria
- Younger than 18 years of age
- Tendinitis calcarea
- Full thickness rotator cuff tear
- Suspicion of capsulitis adhesiva after clinical examination
- Glenohumeral osteoarthritis
- Medication that potentially act on central pain sensitisation (e.g. pregabalin, amitriptylin, duloxetine)
- Use of opioid analgesics, e.g. oxycodone.
- Suspicion of symptomatic acromioclavicular osteoarthritis (e.g. positive cross body adduction test)
- History of fractures or dislocations of the shoulder
- Cardiac disease
- Comorbidities: neurological disorders (e.g. plexus lesion), rheumatic disorders (e.g. polymyalgia rheumatic), muscle dystrophies, metabolic disorders (e.g. hypothyreodism), neoplasms
- Diagnosed with other chronic pain syndrome, e.g. diabetic polyneuropathy, chronic low back pain or fibromyalgia
- Insufficient Dutch language skills
- No informed consent
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL60408.058.16 |