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CompletedNCT03781349Updated Apr 13, 2020

TENS of MENS for Rotator Cuff Tear

An interventional study of MENS and TENS in Rotator Cuff Tear, sponsored by Attikon Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-13.

Sponsored by Attikon Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Mar 2015, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Rotator Cuff Tear

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03

In context

Rotator Cuff Injuries

745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Attikon Hospital is the lead sponsor of 86 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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

Interventions

  • DeviceMENS
  • DeviceTENS
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What researchers measure

Primary outcomes

  1. Pain intensity: NRS

    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

  2. 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.

    Time frame: up to 3 months after intervention

Secondary outcomes

  1. 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)

    Time frame: up to 3 months after intervention

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Study locations

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

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03781349
Lead sponsor
Attikon Hospital
Responsible party
Chrysanthi Batistaki (Assistant Professor of Anesthesiology, Attikon Hospital) — Principal investigator
First posted
Dec 19, 2018
Start date
Mar 2015
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Apr 13, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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