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Clinical Trials/NCT03781349
NCT03781349
Completed
Not Applicable

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

Attikon Hospital1 site in 1 country42 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
Attikon Hospital
Enrollment
42
Locations
1
Primary Endpoint
Pain intensity: NRS
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Attikon Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chrysanthi Batistaki

Assistant Professor of Anesthesiology

Attikon Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain intensity: NRS

Time Frame: 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

Time Frame: 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 Outcomes

  • quality of patients' life: EQ 5D(up to 3 months after intervention)

Study Sites (1)

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