TENS of MENS for Rotator Cuff Tear

NCT ID: NCT03781349

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

MENS

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Interventions

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MENS

Intervention Type DEVICE

TENS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chrysanthi Batistaki

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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EBD624/6-2-15

Identifier Type: -

Identifier Source: org_study_id

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