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

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ClinicalTrials.gov Identifier: NCT02967640
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Tracking Information
First Submitted Date  ICMJE November 16, 2016
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Western Ontario Rotator Cuff Index [ Time Frame: 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 [ Time Frame: 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 [ 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Official Title  ICMJE Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rotator Cuff Tendinitis
  • Chronic Pain
Intervention  ICMJE
  • 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
    Other Names:
    • Ketamine
    • Ketanest
    • Ketaset
    • Calipsol
    • Kalipsol
    • Calypsol
  • 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
Study Arms  ICMJE
  • Experimental: Ketalar
    ketalar injection, subacromial
    Interventions:
    • Drug: Ketalar
    • Drug: NaCl 9%
  • Placebo Comparator: Placebo
    physiological sodium chloride (NaCl 9%) injection, subacromial
    Interventions:
    • Drug: Ketalar
    • Drug: NaCl 9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ola M Lian, md +47 272847 Ola.Midtsether.Lian@helse-mr.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02967640
Other Study ID Numbers  ICMJE 2012/1199
2012-002782-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helse Møre og Romsdal HF
Study Sponsor  ICMJE Helse Møre og Romsdal HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Oystein B Lian, md phd Central Norway Regional Health Authority
PRS Account Helse Møre og Romsdal HF
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP