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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT02967640 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
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Scientific title:
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Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy? |
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Date of first enrolment:
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May 1, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02967640 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Norway
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Contacts
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Name:
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Ola M Lian, md |
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Address:
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Telephone:
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+47 272847 |
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Email:
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Ola.Midtsether.Lian@helse-mr.no |
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Affiliation:
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Name:
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Ola M Lian, MD |
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Address:
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Telephone:
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Email:
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Ola.Midtsether.Lian@helse-mr.no |
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Affiliation:
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Name:
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Oystein B Lian, md phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helse Nord-Trøndelag HF |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of rotator cuff tendinopathy by exercise-related shoulder pain with positive
impingement tests as described by Hawkins and Neers, and MRI findings consistent with
tendinopathy.
- Symptom duration at least 1 year to ensure neuronal ingrowth and NMDAR expression
Exclusion Criteria:
- previous surgery in any shoulder.
- previous cortisone use, either as injections or orally
- symptoms or signs of cervicobrachialgia or polyneuropathy
- full thickness rotator cuff ruptures verified by MRI
- primary inflammatory mediated pain, hence, patients with glenohumeral arthrosis,
glenohumeral arthritis or systemic disorders predisposing for arthritis
- a central component of pain perception manifested by radiating pain in the involved
limb; implying worse outcome after subacromial decompression.
- pregnancy
- breastfeeding
- reduced liver function (Increased serum bilirubin, ASAT or ALAT), decompensated heart
failure (NYHA class 3-4)
- increased intracranial pressure or disease of the central nervous system (CNS)
- chronic alcoholism
- epilepsy
- psychiatric disease, increased intraocular pressure
- acute intermittent porphyria
- hyperthyroidism
- use of thyroid hormones
- upper respiratory tract infections
- pneumonia
- intracranial lesions
- acute head injuries
- ocular injuries
- hydrocephalus
- risk factors predisposing for intra-articular bleeding
- increased risk of infection
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rotator Cuff Tendinitis
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Chronic Pain
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Intervention(s)
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Drug: Ketalar
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Drug: NaCl 9%
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Primary Outcome(s)
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Supraspinatus pressure pain threshold
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Western Ontario Rotator Cuff Index
[Time Frame: 30 minutes]
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Pain
[Time Frame: 30 minutes]
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Oxford Shoulder Score
[Time Frame: 30 minutes]
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Pressure pain tolerance
[Time Frame: 30 minutes]
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Secondary ID(s)
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2012/1199
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2012-002782-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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