Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?

Ketamine

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.

Intervention / Treatment

  • Ketalar (DRUG)
    2,5 ml - if well tolerated immediately followed by another 2,5 ml - of an approximately 1 mg/ml ketalar solution (1 ml of ketalar 10 mg/ml + 9 ml of NaCl 9%) injected 2 times with 1-12 weeks between each injection
  • NaCl 9% (DRUG)
    2,5 ml - if well tolerated immediately followed by another 2,5 ml - of a 9% NaCl solution injected 2 times with 1-12 weeks between each injection

Condition or Disease

  • Rotator Cuff Tendinitis
  • Chronic Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 40 Years and older   (Adult, Older Adult)
    Enrollment: 20 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 01, 2018 ACTUAL
    Primary Completion: Dec 01, 2023 ESTIMATED
    Completion Date: Dec 01, 2023 ESTIMATED
    Study First Posted: Nov 18, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 14, 2023

    Sponsors / Collaborators

    Lead Sponsor: Helse Møre og Romsdal HF
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Kristiansund, Norway

    Participant Groups

    • ketalar injection, subacromial

    • physiological sodium chloride (NaCl 9%) injection, subacromial

    Eligibility Criteria

    Sex: All
    Minimum Age: 40
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • Comparison of supraspinatus pressure pain threshold measured in Lbs/cm3, after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against ringer acetate injection

    Secondary Outcomes

    • Comparisons of shoulder function assessed by Western Ontario Rotator Cuff index in the same patient group after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against Ringer acetate injection.

    • Comparison of shoulder function assessed by Oxford Shoulder Score after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against Ringer acetate injection.

    • Comparison of pain assessed by a visual analogue scale both at rest and abduction, after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against Ringer acetate injection.

    • Comparison of pressure pain tolerance measured in Lbs/cm3, both at rest and abduction, after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against Ringer acetate injection.

    More Details

    NCT Number: NCT02967640
    Other IDs: 2012/1199
    Study URL: https://clinicaltrials.gov/study/NCT02967640
    Last updated: Sep 29, 2023