Microwave Diathermy for Treating Nonspecific Chronic Neck Pain

Neck Pain Clinical Trial

— MOFIS  

Official title:

Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487122
• Other study ID #: MOjaao
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: December 6, 2011
• Start date: September 2008
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: Health Service of Andalucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Radiation:
• Continuous microwave
Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Health Service of Andalucia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain at six months	Pain as measured by visual analogic scale	Baseline. At three weeks. At six months
Primary	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
Primary	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