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Central pain sensitisation or (peri)articular damage: the origin of pain in SAPS A randomised, placebo controlled, blinded, cross-over trial

Central pain sensitisation or (peri)articular damage: the origin of pain in SAPS A randomised, placebo controlled, blinded, cross-over trial - PARTItrial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47590
Enrollment
40
Registered
2017-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronische pijn in de schouder Painful Arc Syndrome Subacromial Impingement Syndrome

Interventions

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 0.9

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)