Low Back PainPhase 2NCT01570127
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
A Phase 2 study testing Individualized Acupuncture, Standardized Acupuncture and Waiting in people with Low Back Pain, run by Dongwoo Nam at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Individualized Acupuncture, Standardized Acupuncture and Waiting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Dec 2012
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients suffering Low Back Pain.
- Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
- Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
- Voluntary participants who have completed the consent.
Who cannot join
- Low back trauma history within 6 months.
- Low back surgery history within 6 months.
- Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
- Pain in other parts of the body more severe than low back pain.
- Mental problems that can influence the pain or results of questionnaire.
- Diseases that can interfere absorption, metabolism and excretion of medicine.
- History of alcohol or drug abuse within 12 months of the study.
- Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, 130-872
Dongwoo Nam, Ph.D, +82-2-958-1827, hanisanam@hanmail.net
Dongwoo Nam, Ph.D
About this study
Official title: Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
The purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.
Read the detailed description
To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.
Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)
The change of pain and physical functions will be compared among the four groups.
So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.
- Conditions
- Low Back Pain
- Being tested
- Individualized Acupuncture, Standardized Acupuncture, Sham Acupuncture, Waiting
- Keywords
- Individualized Acupuncture, Standardized Acupuncture, Low Back Pain, Randomized Controlled Trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized AcupunctureProcedure or surgery
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Standardized AcupunctureProcedure or surgery
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
Sham AcupunctureProcedure or surgery
Also called Park Sham Device
The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.
WaitingOther
Also called No interventions
No interventions were applied to the patients in this group.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Acupuncture | Experimental | The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine. Receives: Procedure: Individualized Acupuncture |
| Standardized Acupuncture | Experimental | The patients in this group received standardized acupuncture treatment using the same acupuncture points, applied by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on literature review of RCTs. Receives: Procedure: Standardized Acupuncture |
| Sham acupuncture | Sham comparator | Non-penetrating acupuncture device, Park-sham acupuncture, was applied to the patients. The appearance of the acupuncture is same but the needles do not penetrate the skin. Receives: Procedure: Sham Acupuncture |
| Waiting | No intervention | No interventions were applied to the patients in this group. Only assessments were made at each visit. Receives: Other: Waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Visual analog scale (VAS) is a tool used to measure pain. The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
Measured: at baseline and after 6 weeks of treatment.
Secondary outcomes (3)
Roland - Morris Disability Questionnaire
Roland - Morris Disability Questionnaire (RMDQ) is scored by adding up the number of items checked by the patients, among the 24 items concerning various disablilities caused by low back pain. The score can therefore vary from 0 to 24. Higher the scores represent worse disabilities.
Measured: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
SF-36
The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
Measured: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Adverse Events
Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported.
Measured: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongwoo Nam
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Gachon University Gil Medical Center
- Responsible party
- Sponsor-investigator, Dongwoo Nam, Kyunghee University Medical Center
- Investigators
- Jae-Dong Lee, Ph.D, Study chair, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570127
- Sponsor's protocol ID
- KOMCIRB-02-20101130-02
- Status last verified
- Apr 2012
- First submitted
- 26 Mar 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT01570127
- Acronym / sponsor ID
- KOMCIRB-02-20101130-02
- Conditions
- Low Back Pain
- Keywords
- Individualized Acupuncture, Standardized Acupuncture, Low Back Pain, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Dongwoo NamUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Gachon University Gil Medical Center
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Apr 2012 (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 purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.
Detailed description
To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.
Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)
The change of pain and physical functions will be compared among the four groups.
So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individualized Acupuncture | Experimental | Procedure: Individualized AcupunctureThe patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine. |
| Standardized Acupuncture | Experimental | Procedure: Standardized AcupunctureThe patients in this group received standardized acupuncture treatment using the same acupuncture points, applied by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on literature review of RCTs. |
| Sham acupuncture | Sham comparator | Procedure: Sham AcupunctureNon-penetrating acupuncture device, Park-sham acupuncture, was applied to the patients. The appearance of the acupuncture is same but the needles do not penetrate the skin. |
| Waiting | No intervention | Other: WaitingNo interventions were applied to the patients in this group. Only assessments were made at each visit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients suffering Low Back Pain.
- Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
- Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
- Voluntary participants who have completed the consent.
Key exclusion criteria (8 listed)
- Low back trauma history within 6 months.
- Low back surgery history within 6 months.
- Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
- Pain in other parts of the body more severe than low back pain.
- Mental problems that can influence the pain or results of questionnaire.
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 |
|---|---|---|
| Individualized AcupunctureThe treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) | Procedure or surgery | Individualized Acupuncture |
| Standardized AcupunctureThe treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used. | Procedure or surgery | Standardized Acupuncture |
| Sham AcupunctureAlso: Park Sham DeviceThe treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long. | Procedure or surgery | Sham acupuncture |
| WaitingAlso: No interventionsNo interventions were applied to the patients in this group. | Other | Waiting |
Primary outcome
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Time frame: at baseline and after 6 weeks of treatment.
Visual analog scale (VAS) is a tool used to measure pain. The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
3 secondary outcomes
Roland - Morris Disability Questionnaire
Time frame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
SF-36
Time frame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Adverse Events
Time frame: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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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.
Jae-Dong Lee, Ph.D study chair
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individualized Acupuncture, Standardized Acupuncture and Waiting in people with Low Back Pain, run by Dongwoo Nam at 1 site in South Korea.
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 4 inclusion and 8 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 6 Apr 2012. 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 South Korea. 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.
What does this phase mean?
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 Dongwoo Nam, Ph.D. (+82-2-958-1827, hanisanam@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment. (time frame: at baseline and after 6 weeks of treatment.). 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 6 Apr 2012.