Neck PainMOFISNCT01487122
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
A study testing Continuous microwave and Pulsed microwaves in people with Neck Pain, run by Andalusian Health Service.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Continuous microwave and Pulsed microwaves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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...)
Who cannot join
- pregnancy
- sick leave
- litigation
- claims because the neck pain.
About this study
Official title: 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.
- Conditions
- Neck Pain
- Being tested
- Continuous microwave, Pulsed microwaves, Sham microwaves
- Keywords
- Diathermy, Neck Pain
- Medical subject headings
- Neck Pain, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous microwaveRadiation
Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
Pulsed microwavesRadiation
Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
Sham microwavesProcedure or surgery
Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Continuous Microwave | Experimental | Not described Receives: Radiation: Continuous microwave |
| Pulsed Microwaves | Experimental | Not described Receives: Radiation: Pulsed microwaves |
| sham microwaves | Sham comparator | Not described Receives: Procedure: Sham microwaves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain at six months
Pain as measured by visual analogic scale
Measured: 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"
Measured: 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
Measured: Baseline. At three weeks. At six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Alfonso Andrade Ortega, Andalusian Health Service
- Investigators
- Juan A Andrade Ortega, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487122
- Sponsor's protocol ID
- MOjaao
- Acronym
- MOFIS
- Status last verified
- Dec 2011
- First submitted
- 1 Dec 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Diathermy for Treating Nonspecific Chronic Neck Pain. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01487122
- Acronym / sponsor ID
- MOFIS / MOjaao
- Conditions
- Neck Pain
- Keywords
- Diathermy, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Andalusian Health ServiceOther government
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Microwave | Experimental | Radiation: Continuous microwave |
| Pulsed Microwaves | Experimental | Radiation: Pulsed microwaves |
| sham microwaves | Sham comparator | Procedure: Sham microwaves |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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...)
Key exclusion criteria (4 listed)
- pregnancy
- sick leave
- litigation
- claims because the neck pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous microwaveContinuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks | Radiation | Continuous Microwave |
| Pulsed microwavesPulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks | Radiation | Pulsed Microwaves |
| Sham microwavesUnplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks | Procedure or surgery | sham microwaves |
Primary outcome
Change from baseline in pain at six months
Time frame: Baseline. At three weeks. At six months
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
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
Quality of life as measured by SF-36 questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A Andrade Ortega, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Continuous microwave and Pulsed microwaves in people with Neck Pain, run by Andalusian Health Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain at six months (time frame: Baseline. At three weeks. At six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.