Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979287
• Other study ID #: IFC Therapy and Exercise
• Status: Completed
• Phase: N/A
• Start date: July 13, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: February 2020
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 15, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• 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: Ergonomic advices on reducing repetitive movements and/or maintained positions 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
The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of: Ergonomic advices on reducing repetitive movements and/or maintained positions 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

Locations

Country	Name	City	State
Spain	University of Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain intensity	Participants will rate the intensity of their neck pain at rest on an 11-point numeric pain rating scale, where 0 is no pain and 11 maximum pain. The subjects will be ask to indicate the pain levels that they experienced before treatment and after treatment.	From baseline to immediately after treatment
Primary	Disability	The Neck Disability Index (NDI) will be used in the Spanish version to measure level of disability of the neck area during the daily life activities.; where under 9 denotes No Disability; from 10 to 29 denotes Slight Disability; from 30 to 49 denotes Moderate Disability; from 50 to 69 denotes Severe Disability and more tan 70 denote Complete Disability.	From baseline to immediately after treatment
Secondary	Range of movement (ROM)	The secondary outcome measure will be the active cervical range of motion assessed with the CROM device (Performance Attainment Associates, Lindstrom, MN). The measurements will be made separately for each direction and in a standard sequence: flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation. Two measurements will be recorded for each movement and the average of the two measurements will be used in the analysis of results	From baseline to immediately after treatment