Rotator Cuff TendinitisPhase 2/3NCT02967640
Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
A Phase 2/3 study testing Ketalar and NaCl 9% in people with Rotator Cuff Tendinitis and Chronic Pain, run by Helse Møre og Romsdal HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rotator Cuff Tendinitis, Chronic Pain
- What is being tested?
- Ketalar and NaCl 9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- 30 May 2018to 30 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Orthopedic Surgery, Kristiansund Hospital
Kristiansund
About this study
Official title: Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
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
- Being tested
- Ketalar, NaCl 9%
- Keywords
- Ketamine, Analgesics, Excitatory Amino Acid Antagonists, Receptors, Glutamate, Shoulder
- Medical subject headings
- Rotator Cuff Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetalarDrug
Also called Ketamine, Ketanest, Ketaset, Calipsol
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%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
| Study group | Role | What they receive |
|---|---|---|
| Ketalar | Experimental | ketalar injection, subacromial Receives: Drug: Ketalar; Drug: NaCl 9% |
| Placebo | Placebo comparator | physiological sodium chloride (NaCl 9%) injection, subacromial Receives: Drug: Ketalar; Drug: NaCl 9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 30 minutes
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start30 May 2018
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oystein B Lian, md phd, Study chair, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967640
- Sponsor's protocol ID
- 2012/1199
- Other IDs
- 2012-002782-35
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2016
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
- ClinicalTrials.gov ID
- NCT02967640
- Acronym / sponsor ID
- 2012/1199
- Conditions
- Rotator Cuff Tendinitis, Chronic Pain
- Keywords
- Ketamine, Analgesics, Excitatory Amino Acid Antagonists, Receptors, Glutamate, Shoulder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketalar | Experimental | Drug: Ketalar, Drug: NaCl 9%ketalar injection, subacromial |
| Placebo | Placebo comparator | Drug: Ketalar, Drug: NaCl 9%physiological sodium chloride (NaCl 9%) injection, subacromial |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetalarAlso: Ketamine, Ketanest, Ketaset, Calipsol2,5 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 | Drug | Ketalar, Placebo |
| 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 | Drug | Ketalar, Placebo |
Primary outcome
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.
2 secondary outcomes
Pressure pain tolerance
Time frame: 30 minutes
Supraspinatus pressure pain threshold
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oystein B Lian, md phd study chair
Helse Nord-Trøndelag HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketalar and NaCl 9% in people with Rotator Cuff Tendinitis and Chronic Pain, run by Helse Møre og Romsdal HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.