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

Primary Purpose

Rotator Cuff Tendinitis, Chronic Pain

Status
Recruiting
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Ketalar
NaCl 9%
Sponsored by
Helse Møre og Romsdal HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinitis focused on measuring Ketamine, Analgesics, Excitatory Amino Acid Antagonists, Receptors, Glutamate, Shoulder

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopedic Surgery, Kristiansund HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketalar

Placebo

Arm Description

ketalar injection, subacromial

physiological sodium chloride (NaCl 9%) injection, subacromial

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 16, 2016
Last Updated
February 14, 2023
Sponsor
Helse Møre og Romsdal HF
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1. Study Identification

Unique Protocol Identification Number
NCT02967640
Brief Title
Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Official Title
Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinitis, Chronic Pain
Keywords
Ketamine, Analgesics, Excitatory Amino Acid Antagonists, Receptors, Glutamate, Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketalar
Arm Type
Experimental
Arm Description
ketalar injection, subacromial
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
physiological sodium chloride (NaCl 9%) injection, subacromial
Intervention Type
Drug
Intervention Name(s)
Ketalar
Other Intervention Name(s)
Ketamine, Ketanest, Ketaset, Calipsol, Kalipsol, Calypsol
Intervention Description
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
Intervention Name(s)
NaCl 9%
Intervention Description
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
Primary Outcome Measure Information:
Title
Supraspinatus pressure pain threshold
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Western Ontario Rotator Cuff Index
Description
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.
Time Frame
30 minutes
Title
Oxford Shoulder Score
Description
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.
Time Frame
30 minutes
Title
Pain
Description
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.
Time Frame
30 minutes
Title
Pressure pain tolerance
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ola M Lian, md
Phone
+47 272847
Email
Ola.Midtsether.Lian@helse-mr.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oystein B Lian, md phd
Organizational Affiliation
Helse Nord-Trøndelag HF
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopedic Surgery, Kristiansund Hospital
City
Kristiansund
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola M Lian, MD
Email
Ola.Midtsether.Lian@helse-mr.no

12. IPD Sharing Statement

Plan to Share IPD
No

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

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