TENS of MENS for Rotator Cuff Tear

NCT03781349 | Completed

• 1 other identifier: EBD624/6-2-15
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• quality of patients' life: EQ 5D

  up to 3 months after intervention

Study Arms (2)

MENS

ACTIVE COMPARATOR

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

TENS

ACTIVE COMPARATOR

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

Interventions

MENS DEVICE

MENS

TENS DEVICE

TENS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

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

Athens, 12462, Greece

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

GR (1)