Microwave Diathermy for Treating Nonspecific Chronic Neck Pain (MOFIS)

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Radiation: Continuous microwave; Radiation: Pulsed microwaves; Procedure: Sham microwaves

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Health Service of Andalucia
• Investigators: Principal Investigator: Juan A Andrade Ortega, MD

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (ESTIMATE): December 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 7, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Neck Pain; Diathermy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Neck Pain; Hyperthermia
• Other Study ID Numbers: MOjaao