TENS of MENS for Rotator Cuff Tear

Comparative Efficacy on Pain of Two Non-pharmacological Treatments (TENS or MENS) in Patients With Partial Rotator Cuff Tears. A Randomized Trial

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 Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: TENS; Device: MENS

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 12462
    • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: MENS
Active Comparator: 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	Device: TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity: NRS	Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity	up to 3 months after intervention
Disability	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.	up to 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of patients' life: EQ 5D	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)	up to 3 months after intervention

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: EBD624/6-2-15

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