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出境医 / 临床实验 / Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : July 13, 2019
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : November 15, 2019
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Locations
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Spain
University of Sevilla
Sevilla, Spain, 41009
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: Alberto Heredia-Rizo, PhD Physiotherapy Department, University of Seville, spain
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE July 13, 2019
Actual Primary Completion Date October 25, 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date October 25, 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 information is only displayed when the study is recruiting subjects
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 February 2020

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

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