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

Phase 2

Recruiting

• Conditions: Rotator Cuff Tendinitis; Chronic Pain
• Interventions: Drug: Ketalar; Drug: NaCl 9%

• Registration Number: NCT02967640
• Lead Sponsor: Helse Møre og Romsdal HF

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Study Start: 2018-05-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketalar	NaCl 9%	ketalar injection, subacromial
Placebo	NaCl 9%	physiological sodium chloride (NaCl 9%) injection, subacromial
Ketalar	Ketalar	ketalar injection, subacromial
Placebo	Ketalar	physiological sodium chloride (NaCl 9%) injection, subacromial

Primary Outcome Measures

Name	Time	Method
Supraspinatus pressure pain threshold	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

Secondary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index	30 minutes	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.
Oxford Shoulder Score	30 minutes	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.
Pain	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.
Pressure pain tolerance	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.

Trial Locations

Locations (1)

Department of Orthopedic Surgery, Kristiansund Hospital; 🇳🇴 Kristiansund, Norway