Chronic Low Back PainPhase 1/2NCT00779818
Electrical Acupuncture and Laser Therapy for Low Back Pain
A Phase 1/2 study testing Electrical acupuncture and Laser in people with Chronic Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
This is a treatment for low back pain using electrical stimulation and laser for 6 weeks. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Electrical acupuncture and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2009
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low back pain for over 6 weeks
Who cannot join
- Individuals with cancer
- Tuberculosis
- Pacemakers
- Pregnancy
- Osteoporosis
- Heart disease
Show all 14Show fewer
- Kidney failure
- Thyroid disorders
- Diabetes
- Chronic disease
- Neurological diseases
- Skin or bleeding disorders
- Currently taking drugs or medications
- A health history questionnaire will be used to screen subjects
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan College of Chiropractic
Chesterfield, Missouri, 63006
About this study
This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.
Read the detailed description
The purpose of the study is to investigate the effects of electroacupuncture and laser therapy to treat chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Electrical acupuncture, Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical acupunctureDevice
Treatment by electrical acupuncture
LaserDevice
Treatment by laser
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Treatment by electrical acupuncture Receives: Device: Electrical acupuncture |
| Group 2 | Experimental | Treatment by laser Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Low Back Pain Disability Index, VAS Questionnaire, Revised Oswestry Pain Questionnaire
Measured: Before treatment and every two weeks for six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779818
- Sponsor's protocol ID
- RD1117060051
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Acupuncture and Laser Therapy for Low Back Pain
- ClinicalTrials.gov ID
- NCT00779818
- Acronym / sponsor ID
- RD1117060051
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 24 Oct 2008 (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 is a treatment for low back pain using electrical stimulation and laser for 6 weeks.
Detailed description
The purpose of the study is to investigate the effects of electroacupuncture and laser therapy to treat chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Electrical acupunctureTreatment by electrical acupuncture |
| Group 2 | Experimental | Device: LaserTreatment by laser |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Low back pain for over 6 weeks
Key exclusion criteria (14 listed)
- Individuals with cancer
- Tuberculosis
- Pacemakers
- Pregnancy
- Osteoporosis
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 |
|---|---|---|
| Electrical acupunctureTreatment by electrical acupuncture | Device | Group 1 |
| LaserTreatment by laser | Device | Group 2 |
Primary outcome
Measure: Low Back Pain Disability Index, VAS Questionnaire, Revised Oswestry Pain Questionnaire
Time frame: Before treatment and every two weeks for six weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Electrical acupuncture and Laser in people with Chronic Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
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 1 inclusion and 14 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 Oct 2008. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact John Zhang, MD, PhD (636-230-1920, john.zhang@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Low Back Pain Disability Index, VAS Questionnaire, Revised Oswestry Pain Questionnaire (time frame: Before treatment and every two weeks for six 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 Oct 2008.