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NCT Number: NCT02967640

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

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.

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Key information

Conditions

Rotator Cuff Tendinitis Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Orthopedic Surgery, Kristiansund Hospital

Kristiansund, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Primary outcomes

  1. Pain

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Pressure pain tolerance

    Time frame: 30 minutes

    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.

  2. Supraspinatus pressure pain threshold

    Time frame: 30 minutes

    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

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2016
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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