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NCT Number: NCT03953339

Neuropathy of the Suprascapular Nerve Before and After Reconstruction of the Cuff

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.

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Key information

Conditions

Cuff Rotator Full Thickness Tear Cuff Rotator Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Balgrist

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Release or no release of the suprascapular nerve

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Acronym: Neurospura

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 16, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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