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Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff (Neurospura)

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ClinicalTrials.gov Identifier: NCT03953339
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cuff Rotator Full Thickness Tear Cuff Rotator Syndrome Procedure: Release or no release of the suprascapular nerve Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019

Arm Intervention/treatment
Active Comparator: no release
no release of the suprascapular nerve during arthroscopic repair of a rotator cuff tendon repair
Procedure: Release or no release of the suprascapular nerve
Experimental: release
arthroscopic release of the suprascapular nerve according to the established, standard technique during arthroscopic repair of a rotator cuff tendon repair
Procedure: Release or no release of the suprascapular nerve



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. Maximal daily pain on visual analog scale [ Time Frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months ]
    Measurement of pain using a visual analog scale 100 points maximal imaginable pain; 0 no pain

  2. Active range of motion [ Time Frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months ]
    Measurement of active elevation, abduction external and internal rotation in degrees measured with a handheld goniometer.

  3. Strength [ Time Frame: preoperatively and change from preoperatively to 3 months and change from 3 to 12 months ]
    Isometric measurement of strength of shoulder abduction in pounds (1 pound represents 1 point in the scoring system)using a validated dynamometer



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent
  • MRI diagnosis of partial or full thickness rotator cuff tear

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953339


Locations
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Switzerland
University Hospital Balgrist
Zurich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital

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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03953339     History of Changes
Other Study ID Numbers: NeuroW514
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries