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Microwave Diathermy for Treating Nonspecific Chronic Neck Pain (MOFIS)

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous microwave
Pulsed microwaves
Sham microwaves
Sponsored by
Health Service of Andalucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Diathermy, Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • to be between 18 and 65 years old
  • to be diagnosed with chronic nonspecific neck pain (i.e. during more than 3 months in the absence of red flags (unexplained weight loss, fever, neurological signs, history of cancer, history of inflammatory conditions...)

Exclusion Criteria:

  • pregnancy
  • sick leave
  • litigation
  • claims because the neck pain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Continuous Microwave

    Pulsed Microwaves

    sham microwaves

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline in pain at six months
    Pain as measured by visual analogic scale
    Change from baseline in neck disability at six months
    Neck disability as measured by "Neck Disability Index" and "Northwick Park Neck Pain Questionnaire"
    Change from baseline in quality of life at six months
    Quality of life as measured by SF-36 questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2011
    Last Updated
    December 6, 2011
    Sponsor
    Health Service of Andalucia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01487122
    Brief Title
    Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
    Acronym
    MOFIS
    Official Title
    Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Health Service of Andalucia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomised controlled trial aims to compare the effect of microwave diathermy (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain patients. Every patient will also be treated by exercise and transcutaneous electrical neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves is justified in terms of pain relief or reduction of disability in this patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain
    Keywords
    Diathermy, Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    145 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous Microwave
    Arm Type
    Experimental
    Arm Title
    Pulsed Microwaves
    Arm Type
    Experimental
    Arm Title
    sham microwaves
    Arm Type
    Sham Comparator
    Intervention Type
    Radiation
    Intervention Name(s)
    Continuous microwave
    Intervention Description
    Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
    Intervention Type
    Radiation
    Intervention Name(s)
    Pulsed microwaves
    Intervention Description
    Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham microwaves
    Intervention Description
    Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
    Primary Outcome Measure Information:
    Title
    Change from baseline in pain at six months
    Description
    Pain as measured by visual analogic scale
    Time Frame
    Baseline. At three weeks. At six months
    Title
    Change from baseline in neck disability at six months
    Description
    Neck disability as measured by "Neck Disability Index" and "Northwick Park Neck Pain Questionnaire"
    Time Frame
    Baseline. At three weeks. At six months
    Title
    Change from baseline in quality of life at six months
    Description
    Quality of life as measured by SF-36 questionnaire
    Time Frame
    Baseline. At three weeks. At six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: to be between 18 and 65 years old to be diagnosed with chronic nonspecific neck pain (i.e. during more than 3 months in the absence of red flags (unexplained weight loss, fever, neurological signs, history of cancer, history of inflammatory conditions...) Exclusion Criteria: pregnancy sick leave litigation claims because the neck pain.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan A Andrade Ortega, MD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Microwave Diathermy for Treating Nonspecific Chronic Neck Pain

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