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

Cuff Rotator Syndrome Clinical Trial

— Neurospura  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953339
• Other study ID #: NeuroW514
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: February 18, 2019

Study information

• Verified date: May 2019
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cuff Rotator Full Thickness Tear
• Cuff Rotator Syndrome
• Rotator Cuff Injuries

Intervention

Procedure:
• Release or no release of the suprascapular nerve

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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