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

NCT ID: NCT02967640

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketalar

ketalar injection, subacromial

Group Type: EXPERIMENTAL

Ketalar

Intervention Type: 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%

Intervention Type: 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

Placebo

physiological sodium chloride (NaCl 9%) injection, subacromial

Group Type: PLACEBO_COMPARATOR

Ketalar

Intervention Type: 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%

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Ketamine; Ketanest; Ketaset; Calipsol; Kalipsol; Calypsol

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oystein B Lian, md phd

Role: STUDY_CHAIR

Helse Nord-Trøndelag HF

Locations

Department of Orthopedic Surgery, Kristiansund Hospital

Kristiansund, , Norway

Countries

Norway

Other Identifiers

2012-002782-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/1199

Identifier Type: -

Identifier Source: org_study_id