Electro-massage in Subjects With Subacromial Pain Syndrome

NCT03338283 | Completed DMC

• 1 other identifier: USBlanca
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  Change from Baseline Constant Scale at 3 weeks

Other Outcomes (1)

• Range of shoulder´s motion (ROM)

  Change from Baseline ROM at 3 weeks

Study Arms (2)

Electromassage

EXPERIMENTAL

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

Conservatory Treatment

ACTIVE COMPARATOR

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

Interventions

Electromassage OTHER

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.

Electromassage

Conservatory treatment OTHER

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.

Conservatory Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry

Seville, 41009, Spain

Location

Study Officials

• Manuel Albornoz-Cabello, PhD

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 9, 2017
• Study Start: December 15, 2017
• Primary Completion: March 14, 2018
• Study Completion: March 14, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)