Electro-massage in Subjects With Subacromial Pain Syndrome

NCT ID: NCT03338283

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2018-03-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electromassage

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Conservatory treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Alberto Marcos Heredia-Rizo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Albornoz-Cabello, PhD

Role: STUDY_DIRECTOR

University of Seville

Locations

Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry

Seville, , Spain

Countries

Spain

Other Identifiers

USBlanca

Identifier Type: -

Identifier Source: org_study_id