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

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.

Study Overview

• Status: Completed
• Conditions: Cuff Rotator Full Thickness Tear; Cuff Rotator Syndrome
• Intervention / Treatment: Procedure: Release or no release of the suprascapular nerve

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electromyographic assessment of suprascapular nerve function	sharp waves, complex repetitive discharges and fasciculations in supra- and infraspinatus muscles. Presence or absence	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	preoperatively, change from preoperatively to 3 months and change from 3 to 12 months
electromyographic assessment of suprascapular nerve function	conduction velocity (m/sec)	preoperatively, change from preoperatively to 3 months and change from 3 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal daily pain on visual analog scale	Measurement of pain using a visual analog scale 100 points maximal imaginable pain; 0 no pain	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.	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	preoperatively and change from preoperatively to 3 months and change from 3 to 12 months

Collaborators and Investigators

• Sponsor: Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): February 18, 2019
• Study Completion (Actual): February 18, 2019

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NeuroW514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No