CompletedPhase 2ketamine
Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Sponsored by Helse Møre og Romsdal HF
NCT ID
NCT02967640
Target Enrollment
14 participants
Start Date
2018-05-30
Est. Completion
2024-12-30
About This Study
The hypothesis of the present study is that in patients with rotator cuff tendinopathy a specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1 has been demonstrated to be crucial for pain regulation in various pain disorders, and in biopsies from patients with tendinopathy, NMDAR1 was found to be activated. To test this hypothesis a specific NMDA receptor antagonist, ketalar (ketamine), will be injected guided by ultrasound into the subacromial space in patients with rotator cuff tendinopathy, and subsequently the pain response will be assessed.
Conditions Studied
Interventions
- •Ketalar
- •NaCl 9%
Eligibility
Age:40 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
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
Study Locations (1)
Department of Orthopedic Surgery, Kristiansund Hospital
Kristiansund, Norway