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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967640
• Other study ID #: 2012/1199
• Secondary ID: 2012-002782-35
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2018
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Helse Møre og Romsdal HF
• Contact: Ola M Lian, md
• Phone: +47 272847
• Email: Ola.Midtsether.Lian[@]helse-mr.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Tendinopathy

Intervention

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
• 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

Locations

Country	Name	City	State
Norway	Department of Orthopedic Surgery, Kristiansund Hospital	Kristiansund

Sponsors (1)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supraspinatus pressure pain threshold	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	30 minutes
Secondary	Western Ontario Rotator Cuff Index	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.	30 minutes
Secondary	Oxford Shoulder Score	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.	30 minutes
Secondary	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	Pressure pain tolerance	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.	30 minutes