TENS of MENS for Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781349
• Other study ID #: EBD624/6-2-15
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Device:
• MENS

• TENS

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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