Low Back PainANLBPNCT01049074
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)
A study testing Acupuncture Treatment in people with Low Back Pain, run by Beijing Hospital of Traditional Chinese Medicine at 2 sites in 2 countries.
Trial summary
Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupuncture Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 534 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2008to Nov 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
- The patient who is from 18 to 79 years old.
- The patient who can comprehensively understand and fill in the questionnaires about the disease.
- The patient who suffered problems no less than 12 weeks.
- The patient who have not the other diseases which can result in back pain.
- The patient who received the clear examinations of X-ray, CT scan or MRI.
- The patient who wrote the informed consents.
Who cannot join
- The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
- The patient who have the hemorrhagic disease such as hemophilia.
- The patient who have the spinal diseases which have not been diagnosed clearly.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Beijing TCM Hospital
Beijing, Beijing Municipality, 100010
Peng Chen, M.D., 86-10-52176636, chenpenger@yahoo.com.cn
Romania1 site
- Active, not recruiting
Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
Lasi
About this study
Official title: A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)
Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.
Read the detailed description
He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.
- Conditions
- Low Back Pain
- Being tested
- Acupuncture Treatment, Sham acupuncture
- Keywords
- Low Back Pain, Acupuncture, RCT
- 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.
Acupuncture TreatmentOther
Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.
Sham acupunctureOther
Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.
| Study group | Role | What they receive |
|---|---|---|
| Verus acupuncture | Experimental | Not described Receives: Other: Acupuncture Treatment |
| Sham acupuncture | Sham comparator | Not described Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of SF-36
Measured: 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary outcomes (1)
Oswestry Disability Index (ODI)
Measured: 4 weeks, 8 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startNov 2008
- Primary completionNov 2010 (estimated)
- Study completionNov 2011 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Linpeng Wang, M.D., Study chair, Beijing TCM HospitalStratulat Ioan Sorin, M.D., Principal investigator, Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049074
- Sponsor's protocol ID
- JKH 081
- Acronym
- ANLBP
- Status last verified
- Nov 2008
- First submitted
- 13 Jan 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)
- ClinicalTrials.gov ID
- NCT01049074
- Acronym / sponsor ID
- ANLBP / JKH 081
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Acupuncture, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 14 Jan 2010 (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.
Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.
Detailed description
He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verus acupuncture | Experimental | Other: Acupuncture Treatment |
| Sham acupuncture | Sham comparator | Other: Sham acupuncture |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
- The patient who is from 18 to 79 years old.
- The patient who can comprehensively understand and fill in the questionnaires about the disease.
- The patient who suffered problems no less than 12 weeks.
- The patient who have not the other diseases which can result in back pain.
Key exclusion criteria (3 listed)
- The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
- The patient who have the hemorrhagic disease such as hemophilia.
- The patient who have the spinal diseases which have not been diagnosed clearly.
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 |
|---|---|---|
| Acupuncture TreatmentAcupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes. | Other | Verus acupuncture |
| Sham acupunctureSham acupuncture is inserting needles superficially, without manipulating, into specific points on the body. | Other | Sham acupuncture |
Primary outcome
Score of SF-36
Time frame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Linpeng Wang, M.D. study chair
Beijing TCM Hospital
Stratulat Ioan Sorin, M.D. principal investigator
Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Treatment in people with Low Back Pain, run by Beijing Hospital of Traditional Chinese Medicine at 2 sites in 2 countries.
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 7 inclusion and 3 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 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Romania. 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?
Contact Peng Chen, M.D. (86-10-52176636, chenpenger@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of SF-36 (time frame: 4 weeks, 8 weeks, 12 weeks, 24 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 19 Mar 2010; AzTrials last refreshed its copy on 6 Nov 2026.