Cuff Rotator Full Thickness TearNeurospuraNCT03953339
Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff
A study testing Release or no release of the suprascapular nerve in people with Cuff Rotator Full Thickness Tear and Cuff Rotator Syndrome, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The suprascapular nerve innervates the musculi supra- and infraspinatus, which, as part of the rotator cuff, allow lifting and external rotation in the shoulder joint. Damage to this nerve can lead to pain and functional deficit. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cuff Rotator Full Thickness Tear, Cuff Rotator Syndrome
- What is being tested?
- Release or no release of the suprascapular nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 18 Feb 2019
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- MRI diagnosis of partial or full thickness rotator cuff tear
Who cannot join
- Previous surgery
- Fatty muscle infiltration Goutallier stages III and IV
- Diabetes mellitus
- pregnancy
- unwillingness or contraindications for Magnetic resonance imaging
- unwillingness or contraindications to electrophysiological assessment
- substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The suprascapular nerve innervates the musculi supra- and infraspinatus, which, as part of the rotator cuff, allow lifting and external rotation in the shoulder joint. Damage to this nerve can lead to pain and functional deficit. Causes of injury are compression by bony / ligamentous anomalies, fracture sequelae and traction damage. In the literature, a (often subclinical) traction damage is increasingly claimed by a muscle retraction after rupture of the supra- and / or infraspinatus tendon as a cause of pain and functional disturbances. The retraction of the ruptured tendon-muscular unit is said to lead to traction damage of the nerve, which can be demonstrated by pathological EMG derivations. By repositioning the tendon to its outbreak site, the nerve is occasionally overstretched, so that individual authors propagate a routine nerve decompression as prophylaxis. In individual cases, a previously pathologic EMG result could be improved after reconstitution of an rotator cuff rupture. However, prospective studies are not available.
It is not known how often a nerve damage is present before a rotator cuff operation and it is not known how often the tendon repair leads to nerve damage or recovery of damage. It is not known whether the surgical nerve decompression is associated with reduced postoperative pain and what a profit or what risks bring about a routine decompression of the nerve to the patient. To answer this question, this prospective randomized study is to be carried out.
Read the detailed description
On the basis of preoperative electromyography (EMG) and electroneurography (ENG), the investigators would like to determine the frequency of suprascapular neuropathy in ruptures of supra- and / or infraspinatus tendons and the risk factors for their presence.
In a ruptured rotator cuff, the muscle is partly retracted so much that the innervating nerve (suprascapular nerve) is stretched and has pathological neurological findings. The Investigators now want to analyze how the arthroscopic reconstruction of the nasal suprascapular nerve affects the pre-operative neuropathy. Does the pre-existing nerve recover by decompression (liberation) from surrounding / entangling tissue or does decompression have no influence on measurable neurology? Other patients with rotator cuff ruptures have normal neurological findings preoperatively despite severe retraction of the muscular / tendon unit. In these cases, the investigators are interested in whether the mobilization and reconstruction of the torn muscle / tendon unit leads to a neurologically measurable elongation of the nerve. This nerve stretching is a possible explanation for protracted postoperative pain. With the postoperative electrophysiological measurements we can quantify this nerve change.
The comparison between preoperative and postoperative neurology findings allows confirmation or refutation of our hypothesis.
- Being tested
- Release or no release of the suprascapular nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release or no release of the suprascapular nerveProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| no release | Active comparator | no release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair Receives: Procedure: Release or no release of the suprascapular nerve |
| release | Experimental | arthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair Receives: Procedure: Release or no release of the suprascapular nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
electromyographic assessment of suprascapular nerve function
sharp waves, complex repetitive discharges and fasciculations in supra- and infraspinatus muscles. Presence or absence
Measured: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
electromyographic assessment of suprascapular nerve function
motor latency to supra- and infraspinatus muscles milliseconds
Measured: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
electromyographic assessment of suprascapular nerve function
conduction velocity (m/sec)
Measured: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
Secondary outcomes (3)
Maximal daily pain on visual analog scale
Measurement of pain using a visual analog scale 100 points maximal imaginable pain; 0 no pain
Measured: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
Active range of motion
Measurement of active elevation, abduction external and internal rotation in degrees measured with a handheld goniometer.
Measured: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
Strength
Isometric measurement of strength of shoulder abduction in pounds (1 pound represents 1 point in the scoring system)using a validated dynamometer
Measured: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jan 2014
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Rotator Full Thickness TearStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953339
- Sponsor's protocol ID
- NeuroW514
- Acronym
- Neurospura
- Status last verified
- May 2019
- First submitted
- 29 Jun 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff
- ClinicalTrials.gov ID
- NCT03953339
- Acronym / sponsor ID
- Neurospura / NeuroW514
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 16 May 2019 (actual)
- 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 suprascapular nerve innervates the musculi supra- and infraspinatus, which, as part of the rotator cuff, allow lifting and external rotation in the shoulder joint. Damage to this nerve can lead to pain and functional deficit. Causes of injury are compression by bony / ligamentous anomalies, fracture sequelae and traction damage. In the literature, a (often subclinical) traction damage is increasingly claimed by a muscle retraction after rupture of the supra- and / or infraspinatus tendon as a cause of pain and functional disturbances. The retraction of the ruptured tendon-muscular unit is said to lead to traction damage of the nerve, which can be demonstrated by pathological EMG derivations. By repositioning the tendon to its outbreak site, the nerve is occasionally overstretched, so that individual authors propagate a routine nerve decompression as prophylaxis. In individual cases, a previously pathologic EMG result could be improved after reconstitution of an rotator cuff rupture. However, prospective studies are not available.
It is not known how often a nerve damage is present before a rotator cuff operation and it is not known how often the tendon repair leads to nerve damage or recovery of damage. It is not known whether the surgical nerve decompression is associated with reduced postoperative pain and what a profit or what risks bring about a routine decompression of the nerve to the patient. To answer this question, this prospective randomized study is to be carried out.
Detailed description
On the basis of preoperative electromyography (EMG) and electroneurography (ENG), the investigators would like to determine the frequency of suprascapular neuropathy in ruptures of supra- and / or infraspinatus tendons and the risk factors for their presence.
In a ruptured rotator cuff, the muscle is partly retracted so much that the innervating nerve (suprascapular nerve) is stretched and has pathological neurological findings. The Investigators now want to analyze how the arthroscopic reconstruction of the nasal suprascapular nerve affects the pre-operative neuropathy. Does the pre-existing nerve recover by decompression (liberation) from surrounding / entangling tissue or does decompression have no influence on measurable neurology? Other patients with rotator cuff ruptures have normal neurological findings preoperatively despite severe retraction of the muscular / tendon unit. In these cases, the investigators are interested in whether the mobilization and reconstruction of the torn muscle / tendon unit leads to a neurologically measurable elongation of the nerve. This nerve stretching is a possible explanation for protracted postoperative pain. With the postoperative electrophysiological measurements we can quantify this nerve change.
The comparison between preoperative and postoperative neurology findings allows confirmation or refutation of our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no release | Active comparator | Procedure: Release or no release of the suprascapular nerveno release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair |
| release | Experimental | Procedure: Release or no release of the suprascapular nervearthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent
- MRI diagnosis of partial or full thickness rotator cuff tear
Key exclusion criteria (7 listed)
- Previous surgery
- Fatty muscle infiltration Goutallier stages III and IV
- Diabetes mellitus
- pregnancy
- unwillingness or contraindications for Magnetic resonance imaging
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 |
|---|---|---|
| Release or no release of the suprascapular nerve | Procedure or surgery | no release, release |
Primary outcome
electromyographic assessment of suprascapular nerve function
Time frame: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
sharp waves, complex repetitive discharges and fasciculations in supra- and infraspinatus muscles. Presence or absence
electromyographic assessment of suprascapular nerve function
Time frame: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
motor latency to supra- and infraspinatus muscles milliseconds
electromyographic assessment of suprascapular nerve function
Time frame: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
conduction velocity (m/sec)
3 secondary outcomes
Maximal daily pain on visual analog scale
Time frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
Active range of motion
Time frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
Strength
Time frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months
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 16 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Release or no release of the suprascapular nerve in people with Cuff Rotator Full Thickness Tear and Cuff Rotator Syndrome, run by Balgrist University Hospital at 1 site in Switzerland.
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 7 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 16 May 2019. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
electromyographic assessment of suprascapular nerve function (time frame: preoperatively, change from preoperatively to 3 months and change from 3 to 12 months). The study lists 3 primary outcomes in all. 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 16 May 2019.