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Clinical Trials/NCT03338283
NCT03338283
Completed
Not Applicable

Short-term Efficacy of Interferential Current Electro-massage on Self-perceived Pain and Function in Subjects With Subacromial Pain Syndrome: A Randomized Clinical Trial

University of Seville1 site in 1 country56 target enrollmentDecember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subacromial Pain Syndrome
Sponsor
University of Seville
Enrollment
56
Locations
1
Primary Endpoint
Pain level, assessed by Visual Analogue Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. To evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention.

Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants Methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. Both groups of patients will undergo six physiotherapy sessions (three times a week). The experimental group will undergo a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes will be used. Session length with electrotherapy will be approximately ten minutes.

Registry
clinicaltrials.gov
Start Date
December 15, 2017
End Date
March 14, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alberto Marcos Heredia-Rizo

Assistant Professor

University of Seville

Eligibility Criteria

Inclusion Criteria

  • patients having undergone acromioplasty surgery in the three months prior to the first day of Physiotherapy treatment

Exclusion Criteria

  • Value equal to or less than 45 in Personal Psychological Apprehension Scale, showing any absolute contraindication for Physiotherapy or Electrotherapy treatment, fear or apprehension for Electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with SCS, having been applied local infiltration with corticoids following surgery and having started Physiotherapy treatment before signing informed consent.

Outcomes

Primary Outcomes

Pain level, assessed by Visual Analogue Scale

Time Frame: Change from Baseline Pain level at 3 weeks

This scale is the most accepted to calculate pain level. The range is from 0 (no pain) to 10 (hard pain).

Secondary Outcomes

  • Functional evaluation, assessed by Constant Scale. Reference: Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4(Change from Baseline Constant Scale at 3 weeks)

Study Sites (1)

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