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Electro-massage in Subjects With Subacromial Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03338283
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Alberto Marcos Heredia-Rizo, University of Seville

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.


Condition or disease Intervention/treatment Phase
Subacromial Pain Syndrome Other: Electromassage Other: Conservatory treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : March 14, 2018

Arm Intervention/treatment
Experimental: Electromassage

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.

Other: Electromassage
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.

Active Comparator: Conservatory Treatment
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.
Other: Conservatory treatment
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 Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: Change from Baseline Constant Scale at 3 weeks ]
    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.


Other Outcome Measures:
  1. Range of shoulder´s motion (ROM) [ Time Frame: Change from Baseline ROM at 3 weeks ]
    The flexion, extension, abduction, adduction, internal and external rotation were analyzed. They were measured by goniometer (iPhone app).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338283


Locations
Spain
Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry
Sevilla, Spain, 41009
Sponsors and Collaborators
University of Seville
Investigators
Study Director: Manuel Albornoz-Cabello, PhD University of Seville

Responsible Party: Alberto Marcos Heredia-Rizo, Assistant Professor, University of Seville
ClinicalTrials.gov Identifier: NCT03338283     History of Changes
Other Study ID Numbers: USBlanca
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders