Title

Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
  • Phase

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Status

    Recruiting
  • Intervention/Treatment

    ketamine ...
  • Study Participants

    20
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.
Study Started
May 01
2018
Primary Completion
May 31
2022
Anticipated
Study Completion
May 31
2022
Anticipated
Last Update
Mar 16
2022

Drug Ketalar

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

  • Other names: Ketamine, Ketanest, Ketaset, Calipsol, Kalipsol, Calypsol

Drug NaCl 9%

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

Ketalar Experimental

ketalar injection, subacromial

Placebo Placebo Comparator

physiological sodium chloride (NaCl 9%) injection, subacromial

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
No Results Posted