Back to resultsTENS of MENS for Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
MENS
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear
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
Sites / Locations
- 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MENS
TENS
Arm Description
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 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
Outcomes
Primary Outcome Measures
Pain intensity: NRS
Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03781349
Brief Title
TENS of MENS for Rotator Cuff Tear
Official Title
Comparative Efficacy on Pain of Two Non-pharmacological Treatments (TENS or MENS) in Patients With Partial Rotator Cuff Tears. A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MENS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TENS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MENS
Intervention Type
Device
Intervention Name(s)
TENS
Primary Outcome Measure Information:
Title
Pain intensity: NRS
Description
Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity
Time Frame
up to 3 months after intervention
Title
Disability
Description
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.
Time Frame
up to 3 months after intervention
Secondary Outcome Measure Information:
Title
quality of patients' life: EQ 5D
Description
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)
Time Frame
up to 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
ZIP/Postal Code
12462
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TENS of MENS for Rotator Cuff Tear
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