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
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Diathermy, Neck Pain
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.
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
NCT ID
NCT01487122
First Posted
December 1, 2011
Last Updated
December 6, 2011
Sponsor
Health Service of Andalucia
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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