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The origin of pain in the Subacromial Pain Syndrome.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26751
Enrollment
40
Registered
2017-05-12
Start date
2017-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Subacromial Pain 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 0.90%

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

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
1) (peri)articular pain determined from effect of subacromial injections on pain at rest and during abduction assessed with a visual analogue scale (VAS), 2) pain sensitisation assessed with bilateral Quantitative Sensory Testing (QST), 3) shoulder muscle activation (expressed as Activation Ratios, ARs).

Secondary

MeasureTime frame
Secondary study parameters (determinants) are two anchor questions for pain, findings from ultrasonography, questionnaires and demographics.

Contacts

Public ContactC.L. Overbeek
c.l.overbeek@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)