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

NCT02967640 | Completed Phase 2 DMC

• 2 other identifiers: 2012/11992012-002782-35
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinitis; Chronic Pain

Keywords

Ketamine; Analgesics; Excitatory Amino Acid Antagonists; Receptors, Glutamate; Shoulder

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  30 minutes

Secondary Outcomes (2)

• Pressure pain tolerance

  30 minutes

• Supraspinatus pressure pain threshold

  30 minutes

Study Arms (2)

Ketalar

EXPERIMENTAL

ketalar injection, subacromial

Drug: Ketalar; Drug: NaCl 9%

Placebo

PLACEBO COMPARATOR

physiological sodium chloride (NaCl 9%) injection, subacromial

Drug: Ketalar; Drug: NaCl 9%

Interventions

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

Also known as: Ketamine, Ketanest, Ketaset, Calipsol, Kalipsol, Calypsol

Ketalar; Placebo

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

Ketalar; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead

Study Sites (1)

Department of Orthopedic Surgery, Kristiansund Hospital

Kristiansund, Norway

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Chronic Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Oystein B Lian, md phd

  Helse Nord-Trøndelag HF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: May 30, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 22, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)