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Trial record 46 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

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

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.


Condition or disease Intervention/treatment Phase
Neck Pain Other: Interferential Current and Therapeutic Exercise Program Other: Therapeutic Exercise Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
Estimated Study Start Date : July 10, 2019
Estimated Primary Completion Date : September 5, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979287


Contacts
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Contact: Alberto Heredia-Rizo, PhD +34954486507 amheredia@us.es

Locations
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Spain
University of Sevilla Recruiting
Sevilla, Spain, 41009
Contact: Manuel Albornoz-Cabello         
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: Alberto Heredia-Rizo, PhD Physiotherapy Department, University of Seville, spain

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Responsible Party: Alberto Marcos Heredia-Rizo, Assistant Professor, University of Seville
ClinicalTrials.gov Identifier: NCT03979287     History of Changes
Other Study ID Numbers: IFC Therapy and Exercise
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alberto Marcos Heredia-Rizo, University of Seville:
Chronic Neck Pain
Interferential Current Electrotherapy
Therapeutic Exercise
Physical Therapy

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms