TENS of MENS for Rotator Cuff Tear

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Device: MENS; Device: TENS

• Registration Number: NCT03781349
• Lead Sponsor: Attikon Hospital

Brief Summary

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

Detailed Description

The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a secondary feature, leading to further disability.

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients suffering shoulder pain because of partial thickness rotator cuff tear, confirmed with MRI and ultrasound scanning.
• Patients not receiving any recent pharmacotherapy with NSAIDs during the last month, or surgery at the shoulder area at any time point,
• The referral orthopedic had suggested physiotherapy.

Exclusion Criteria

• Patients with open wounds or skin diseases in the shoulder area
• pregnant women
• patients with any type of neoplastic disease
• patients with pacemakers or serious cardiovascular diseases including arrhythmia, - patients with collagen diseases
• history of shoulder surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MENS	MENS	MENS are applied through placement of six electrodes (size of 4x4cm), of which four were placed exactly like the TENS electrodes and the other two, one in the palm and the other at the height of the asteroid ganglion. Duration of the intervention was 24 min for a total of 15 sessions. The frequency was 50 Hz and the intensity was 100 μA.
TENS	TENS	TENS are applied through the placement of four electrodes on either side of the deltoid muscle, on the front and back surfaces of the shoulder joint for 20 min and each patient received 15 sessions (five per week). A constant current of high frequency was used (100 HZ) and its intensity was initiated at 10mA and was then gradually increased to 15mA

Primary Outcome Measures

Name	Time	Method
Pain intensity: NRS	up to 3 months after intervention	Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity
Disability	up to 3 months after intervention	SPADI questionnaire (shoulder pain and disability questionnaire). It measures pain and disability caused by shoulder diseases, each question ranging between 0 and 10 (with 0 indicating no disability and 10 indicating worst disability). It includes 5 questions about pain and 8 questions about disability.

Secondary Outcome Measures

Name	Time	Method
quality of patients' life: EQ 5D	up to 3 months after intervention	EQ 5D, EuroQol measuring of perceived Health today, Scale 0-100 (with 0 indicating worst health, and 100 indicating best imaginable health as perceived by the patient)

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece