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Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT03979287
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Marcos Heredia-Rizo, University of Seville

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 7, 2019
Estimated Study Start Date  ICMJE July 10, 2019
Estimated Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Neck pain intensity [ Time Frame: From baseline to immediately after treatment ]
    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.
  • Disability [ Time Frame: From baseline to immediately after treatment ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Range of movement (ROM) [ Time Frame: From baseline to immediately after treatment ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
Official Title  ICMJE Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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:

    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
  • 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
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Other: Interferential Current and Therapeutic Exercise Program
  • Active Comparator: 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.
    Intervention: Other: Therapeutic Exercise Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2019
Estimated Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alberto Heredia-Rizo, PhD +34954486507 amheredia@us.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979287
Other Study ID Numbers  ICMJE IFC Therapy and Exercise
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alberto Marcos Heredia-Rizo, University of Seville
Study Sponsor  ICMJE University of Seville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alberto Heredia-Rizo, PhD Physiotherapy Department, University of Seville, spain
PRS Account University of Seville
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP