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Electro-massage in Subjects With Subacromial Pain Syndrome

Primary Purpose

Subacromial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electromassage
Conservatory treatment
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Pain Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electromassage

Conservatory Treatment

Arm Description

Electromassage and conservatory treatment. All subjects will be received a conservatory treatment (1h and 40 min) and electro-massage (10min). The protocol will consist of six sessions, twice a week for three weeks. The duration will be 1 hour and 40 min for the conservatory treatment and 10 min for the electro-massage.

The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.

Outcomes

Primary Outcome Measures

Pain level, assessed by Visual Analogue Scale
This scale is the most accepted to calculate pain level. The range is from 0 (no pain) to 10 (hard pain).

Secondary Outcome Measures

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
This scale is the most accepted at European level. It calculates pain, activities of daily living, mobility and strength. It is a scale validated by the European Society of Shoulder and Elbow Surgery. Several subscales are combined to compute a total score.

Full Information

First Posted
October 29, 2017
Last Updated
March 15, 2018
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT03338283
Brief Title
Electro-massage in Subjects With Subacromial Pain Syndrome
Official Title
Short-term Efficacy of Interferential Current Electro-massage on Self-perceived Pain and Function in Subjects With Subacromial Pain Syndrome: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromassage
Arm Type
Experimental
Arm Description
Electromassage and conservatory treatment. All subjects will be received a conservatory treatment (1h and 40 min) and electro-massage (10min). The protocol will consist of six sessions, twice a week for three weeks. The duration will be 1 hour and 40 min for the conservatory treatment and 10 min for the electro-massage.
Arm Title
Conservatory Treatment
Arm Type
Active Comparator
Arm Description
The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.
Intervention Type
Other
Intervention Name(s)
Electromassage
Intervention Description
Electro-massage that will be performed by a specialist physiotherapist with more than 8 years of experience We use ENDOMED 482 (Enraf Nonius, Spain) for the elecro-massage. the current parameters are: frequency shift at 4000 Hz IFC, 100 Hz AMF in CV mode. We will gradually raise the current intensity until reaching a high level, but not so high as to cause pain or discomfort, nor evident muscle contraction, although a gentle vibration is allowed. The electro-massage was performed on the musculature of the shoulder and neck.
Intervention Type
Other
Intervention Name(s)
Conservatory treatment
Intervention Description
The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.
Primary Outcome Measure Information:
Title
Pain level, assessed by Visual Analogue Scale
Description
This scale is the most accepted to calculate pain level. The range is from 0 (no pain) to 10 (hard pain).
Time Frame
Change from Baseline Pain level at 3 weeks
Secondary Outcome Measure Information:
Title
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
Description
This scale is the most accepted at European level. It calculates pain, activities of daily living, mobility and strength. It is a scale validated by the European Society of Shoulder and Elbow Surgery. Several subscales are combined to compute a total score.
Time Frame
Change from Baseline Constant Scale at 3 weeks
Other Pre-specified Outcome Measures:
Title
Range of shoulder´s motion (ROM)
Description
The flexion, extension, abduction, adduction, internal and external rotation were analyzed. They were measured by goniometer (iPhone app).
Time Frame
Change from Baseline ROM at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Albornoz-Cabello, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Electro-massage in Subjects With Subacromial Pain Syndrome

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