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Microwave Diathermy for Treating Nonspecific Chronic Neck Pain (MOFIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan Alfonso Andrade Ortega, Health Service of Andalucia
ClinicalTrials.gov Identifier:
NCT01487122
First received: December 1, 2011
Last updated: December 6, 2011
Last verified: December 2011

December 1, 2011
December 6, 2011
September 2008
June 2011   (final data collection date for primary outcome measure)
  • Change from baseline in pain at six months [ Time Frame: Baseline. At three weeks. At six months ] [ Designated as safety issue: No ]
    Pain as measured by visual analogic scale
  • Change from baseline in neck disability at six months [ Time Frame: Baseline. At three weeks. At six months ] [ Designated as safety issue: No ]
    Neck disability as measured by "Neck Disability Index" and "Northwick Park Neck Pain Questionnaire"
  • Change from baseline in quality of life at six months [ Time Frame: Baseline. At three weeks. At six months ] [ Designated as safety issue: No ]
    Quality of life as measured by SF-36 questionnaire
Same as current
Complete list of historical versions of study NCT01487122 on ClinicalTrials.gov Archive Site
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Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neck Pain
  • Radiation: Continuous microwave
    Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
  • Radiation: Pulsed microwaves
    Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
  • Procedure: Sham microwaves
    Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
  • Experimental: Continuous Microwave
    Intervention: Radiation: Continuous microwave
  • Experimental: Pulsed Microwaves
    Intervention: Radiation: Pulsed microwaves
  • Sham Comparator: sham microwaves
    Intervention: Procedure: Sham microwaves
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
September 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01487122
MOjaao
No
Juan Alfonso Andrade Ortega, Health Service of Andalucia
Health Service of Andalucia
Not Provided
Principal Investigator: Juan A Andrade Ortega, MD
Health Service of Andalucia
December 2011

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