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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
History of Changes
  Purpose

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.


Condition Intervention
Neck Pain
 Radiation: Continuous microwave
Radiation: Pulsed microwaves
Procedure: Sham microwaves

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Service of Andalucia:

Primary Outcome Measures:
  • 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


Enrollment: 145
Study Start Date: September 2008
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Microwave Radiation: Continuous microwave
Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
Experimental: Pulsed Microwaves 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
Sham Comparator: sham microwaves Procedure: Sham microwaves
Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487122

Sponsors and Collaborators
Health Service of Andalucia
Investigators
Principal Investigator: Juan A Andrade Ortega, MD
  More Information

No publications provided

Responsible Party: Juan Alfonso Andrade Ortega, Head of Physical Medicine and Rehabilitation, Health Service of Andalucia
ClinicalTrials.gov Identifier: NCT01487122     History of Changes
Other Study ID Numbers: MOjaao
Study First Received: December 1, 2011
Last Updated: December 6, 2011
Health Authority: Spain: Clinic Trials Committee of FIBAO (East Andalusia Biomedical Research Foundation)

Keywords provided by Health Service of Andalucia:
Diathermy
Neck Pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013