Clinical trial NCT02967640: Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Official title: Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rotator Cuff Tendinitis
Chronic Pain
Keywords: Ketamine
Analgesics
Excitatory Amino Acid Antagonists
Receptors, Glutamate
Shoulder
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
First posted: 2016-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Supraspinatus pressure pain threshold
timeFrame: 30 minutes
Secondary outcomes:
measure: Western Ontario Rotator Cuff Index
timeFrame: 30 minutes
measure: Oxford Shoulder Score
timeFrame: 30 minutes
measure: Pain
timeFrame: 30 minutes
measure: Pressure pain tolerance
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Department of Orthopedic Surgery, Kristiansund Hospital
Study officials:
affiliation: Helse Nord-Trøndelag HF
name: Oystein B Lian, md phd
role: STUDY_CHAIR
References: