Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

NCT ID: NCT03979287

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-13
• Study Completion Date: 2019-11-15

Brief Summary

Objectives: To analyze the number of sessions needed to achieve a positive impact after combining interferential current therapy and therapeutic exercise, compared with therapeutic exercise alone, on self-reported pain, disability and range of motion in subjects with chronic neck pain.

Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65 years old, with idiopathic chronic neck pain.

Methods: The experimental group who will perform a combined treatment using Interferential current therapy and therapeutic exercise for two weeks. The control group will receive the same program of therapeutic exercise during the same period of time.

Conditions

Neck Pain

Study Design

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

Study Groups

IFC and Therapeutic Exercise Program

Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region

Group Type: EXPERIMENTAL

Interferential Current and Therapeutic Exercise Program

Intervention Type: OTHER

The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

1. Ergonomic advices on reducing repetitive movements and/or maintained positions

2. A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Therapeutic Exercise Program

Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program.

Group Type: ACTIVE_COMPARATOR

Therapeutic Exercise Program

Intervention Type: OTHER

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

1. Ergonomic advices on reducing repetitive movements and/or maintained positions

2. A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Interventions

Interferential Current and Therapeutic Exercise Program

The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

1. Ergonomic advices on reducing repetitive movements and/or maintained positions

2. A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Intervention Type: OTHER

Therapeutic Exercise Program

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

1. Ergonomic advices on reducing repetitive movements and/or maintained positions

2. A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Nonspecific mechanical neck pain (chronic neck pain diagnosed by a physician)
• Age between 18 and 65 years old
• Both males and females
• Non apprehension to electrotherapy (determined by the Personal Psychological Apprehension scale- EAPP)
• Self-reported pain higher than 2 in the 11-point Numeric Pain Rating Scale

Exclusion Criteria

• Metallic implants in the vertebral column
• Apprehension to electrotherapy (a score >45 points in EAPP)
• Cervicogenic headache
• Cervicogenic Dizziness
• Neck pain associated with neurological deficits
• Unexplained fever
• Cervical surgery associated to persistent pain
• Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy)
• Other diagnostics such as visceral pain referred to the neck or non-cervical cause.
• Involvement in litigation
• Manual treatment for the neck-shoulder area in the last month before data collection

• 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

Alberto Heredia-Rizo, PhD

Role: STUDY_DIRECTOR

Physiotherapy Department, University of Seville, spain

Locations

University of Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

IFC Therapy and Exercise

Identifier Type: -

Identifier Source: org_study_id