Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
MOFIS
1 other identifier
interventional
145
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedDecember 7, 2011
December 1, 2011
2.7 years
December 1, 2011
December 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in pain at six months
Pain as measured by visual analogic scale
Baseline. At three weeks. At six months
Change from baseline in neck disability at six months
Neck disability as measured by "Neck Disability Index" and "Northwick Park Neck Pain Questionnaire"
Baseline. At three weeks. At six months
Change from baseline in quality of life at six months
Quality of life as measured by SF-36 questionnaire
Baseline. At three weeks. At six months
Study Arms (3)
Continuous Microwave
EXPERIMENTALPulsed Microwaves
EXPERIMENTALsham microwaves
SHAM COMPARATORInterventions
Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
Eligibility Criteria
You may qualify if:
- 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...)
You may not qualify if:
- pregnancy
- sick leave
- litigation
- claims because the neck pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan A Andrade Ortega, MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 7, 2011
Study Start
September 1, 2008
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
December 7, 2011
Record last verified: 2011-12