Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

NCT03979287 | Completed DMC

• 1 other identifier: IFC Therapy and Exercise
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Neck Pain; Interferential Current Electrotherapy; Therapeutic Exercise; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Range of movement (ROM)

  From baseline to immediately after treatment

Study Arms (2)

IFC and Therapeutic Exercise Program

EXPERIMENTAL

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

Other: Interferential Current and Therapeutic Exercise Program

Therapeutic Exercise Program

ACTIVE COMPARATOR

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.

Other: Therapeutic Exercise Program

Interventions

Interferential Current and Therapeutic Exercise Program 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

IFC and Therapeutic Exercise Program

Therapeutic Exercise Program 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

Therapeutic Exercise Program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Heredia-Rizo, PhD

  Physiotherapy Department, University of Seville, spain

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: July 13, 2019
• Primary Completion: October 25, 2019
• Study Completion: November 15, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)