Cervical RadiculopathyNCT00880828
Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
A study testing FIR cervical collar with Acetaminophen, Conservative cervical collar with Acetaminophen and Acetaminophen only in people with Cervical Radiculopathy and Radicular Pain, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cervical Radiculopathy, Radicular Pain, Acute Neck Pain
- What is being tested?
- FIR cervical collar with Acetaminophen, Conservative cervical collar with Acetaminophen and Acetaminophen only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Oct 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 20 years
- Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following:
- Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
- Muscle weakness in one or more adjacent myotomes.
- Neck Disability Index (NDI) score greater than or equal to 10 points
- Visual analog scale (VAS) score for neck pain greater than or equal to 40mm
Show all 9Show fewer
- C-spine X-ray signs judge by investigator
- Prolong Neck pain for one week or longer
- Written consent from patient
Who cannot join
- Serious somatic or psychiatric disease(s)
- History of spinal tumors or spinal infection
- Ongoing physical therapy within 4 weeks
- Cervical instability judge by investigator
- History of contact dermatitis or known allergic reaction to collar material
- Known allergic reaction to acetaminophen
- Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Randomized, Active Controlled, Single Blind, Parallel Design, Three Arms Trial Comparing Two Different Cervical Collar Combine With Acetaminophen and Acetaminophen Along for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy.
Read the detailed description
Acute neck pain is a relatively common experience that usually declines and disappears within a couple weeks. Some patients do not recover and with time develop chronic cervical pain and nerve root compression which may result in cervical radiculopathy.
Far-infrared (FIR) ray is one of the topics in energy medicine which is tremendously studied for the past few years. A variety of FIR applications showed an enhancement of beneficial effects on healing therapy, even though there is limited technical approach and systemic study placed on the theoretical study of FIR ceramics processing and the emissivity optimizing.
The evident difficulties in finding the appropriate cervical radiculopathy therapy initiated the current study. The aim of the study is to evaluate the efficacy of the FIR cervical collar in patients with long-lasting cervicobrachial pain; in whom the pain had a distribution that corresponded to a specific nerve root compression revealed by MRI or electrophysiological study.
- Being tested
- FIR cervical collar with Acetaminophen, Conservative cervical collar with Acetaminophen, Acetaminophen only
- Keywords
- Cervical Radiculopathy, Radicular Pain, Acute neck pain, Cervicobrachial pain, Far-infrared ray, FIR, Cervical collar, Cervical device, FIR Device
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIR cervical collar with AcetaminophenOther
FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
Conservative cervical collar with AcetaminophenOther
Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
Acetaminophen onlyDrug
Acetaminophen QID/PRN for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | FIR cervical collar plus Acetaminophen Receives: Other: FIR cervical collar with Acetaminophen |
| B | Active comparator | Conservative cervical collar plus Acetaminophen Receives: Other: Conservative cervical collar with Acetaminophen |
| C | Placebo comparator | Acetaminophen only Receives: Drug: Acetaminophen only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
Measured: 4 weeks
Secondary outcomes (6)
Mean of change from baseline in Neck Disability Index after 4 weeks of treatment
Measured: 4 weeks
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment
Measured: 4 weeks
Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment
Measured: 4 weeks
Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment
Measured: 4 weeks
Compare with Acetaminophen consuming of each arm after 4 weeks of treatment
Measured: 4 weeks
Device-related serious adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startAug 2010
- Primary completionApr 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kuo-Sheng Hung, MD, PhD, Principal investigator, Taipei Medical University-Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880828
- Sponsor's protocol ID
- 2008WFCRC-02
- Status last verified
- Sep 2010
- First submitted
- 13 Apr 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized, Active Controlled, Single Blind, Parallel Design, Three Arms Trial Comparing Two Different Cervical Collar Combine With Acetaminophen and Acetaminophen Along for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain
- ClinicalTrials.gov ID
- NCT00880828
- Acronym / sponsor ID
- 2008WFCRC-02
- Keywords
- Cervical Radiculopathy, Radicular Pain, Acute neck pain, Cervicobrachial pain, Far-infrared ray, FIR, Cervical collar, Cervical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 14 Apr 2009 (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.
The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy.
Detailed description
Acute neck pain is a relatively common experience that usually declines and disappears within a couple weeks. Some patients do not recover and with time develop chronic cervical pain and nerve root compression which may result in cervical radiculopathy.
Far-infrared (FIR) ray is one of the topics in energy medicine which is tremendously studied for the past few years. A variety of FIR applications showed an enhancement of beneficial effects on healing therapy, even though there is limited technical approach and systemic study placed on the theoretical study of FIR ceramics processing and the emissivity optimizing.
The evident difficulties in finding the appropriate cervical radiculopathy therapy initiated the current study. The aim of the study is to evaluate the efficacy of the FIR cervical collar in patients with long-lasting cervicobrachial pain; in whom the pain had a distribution that corresponded to a specific nerve root compression revealed by MRI or electrophysiological study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: FIR cervical collar with AcetaminophenFIR cervical collar plus Acetaminophen |
| B | Active comparator | Other: Conservative cervical collar with AcetaminophenConservative cervical collar plus Acetaminophen |
| C | Placebo comparator | Drug: Acetaminophen onlyAcetaminophen only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than 20 years
- Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following:
- Neck Disability Index (NDI) score greater than or equal to 10 points
- Visual analog scale (VAS) score for neck pain greater than or equal to 40mm
- C-spine X-ray signs judge by investigator
Key exclusion criteria (7 listed)
- Serious somatic or psychiatric disease(s)
- History of spinal tumors or spinal infection
- Ongoing physical therapy within 4 weeks
- Cervical instability judge by investigator
- History of contact dermatitis or known allergic reaction to collar material
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 |
|---|---|---|
| FIR cervical collar with AcetaminophenFIR cervical collar with Acetaminophen QID/PRN for 4 weeks | Other | A |
| Conservative cervical collar with AcetaminophenConservative cervical collar with Acetaminophen QID/PRN for 4 weeks | Other | B |
| Acetaminophen onlyAcetaminophen QID/PRN for 4 weeks | Drug | C |
Primary outcome
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment
Time frame: 4 weeks
6 secondary outcomes
Mean of change from baseline in Neck Disability Index after 4 weeks of treatment
Time frame: 4 weeks
Mean of change from baseline in Visual analog scale for neck pain after 2 and 4 weeks of treatment
Time frame: 4 weeks
Mean of change from baseline in nerve conduction velocity (NCV) tests after 4 weeks of treatment
Time frame: 4 weeks
Mean of change from baseline in Nerve Excitability Test (NET) after 2 and 4 weeks of treatment
Time frame: 4 weeks
Compare with Acetaminophen consuming of each arm after 4 weeks of treatment
Time frame: 4 weeks
Device-related serious adverse events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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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.
Kuo-Sheng Hung, MD, PhD principal investigator
Taipei Medical University-Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIR cervical collar with Acetaminophen, Conservative cervical collar with Acetaminophen and Acetaminophen only in people with Cervical Radiculopathy and Radicular Pain, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Mean of change from baseline in Neck Disability Index after 2 weeks of treatment (time frame: 4 weeks). 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 24 Sep 2010; AzTrials last refreshed its copy on 1 Nov 2026.