Electro-massage in Subjects With Subacromial Pain Syndrome

Subacromial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338283
• Other study ID #: USBlanca
• Status: Completed
• Phase: N/A
• First received: October 29, 2017
• Last updated: March 15, 2018
• Start date: December 15, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: March 2018
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Somatoform Disorders
• Subacromial Pain Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Range of shoulder´s motion (ROM)	The flexion, extension, abduction, adduction, internal and external rotation were analyzed. They were measured by goniometer (iPhone app).	Change from Baseline ROM at 3 weeks
Primary	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).	Change from Baseline Pain level at 3 weeks
Secondary	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.	Change from Baseline Constant Scale at 3 weeks