Ankylosing SpondylitisNCT02260284
The Effect of Acupuncture in Treating Chronic Low-back Pain
A study testing Yaotong points acupuncture and standardized acupuncture in people with Ankylosing Spondylitis and Low Back Pain, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankylosing Spondylitis, Low Back Pain
- What is being tested?
- Yaotong points acupuncture and standardized acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with CLBP
- without taking any other medication for the treatment of CLBP in at least 2 last weeks;
- aged from 18 to 50 years;
- without conflict to the written, informed consent signed prior to the enrollment.
Who cannot join
- pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
- complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
- with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
- conditions making treatment difficult (e.g., paralysis, psychoses);
- conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
- previous acupuncture treatment for any condition.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, 610083
About this study
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain
Read the detailed description
We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.
- Conditions
- Ankylosing Spondylitis, Low Back Pain
- Being tested
- Yaotong points acupuncture, the usual care, standardized acupuncture
- Medical subject headings
- Spondylitis, Ankylosing, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yaotong points acupunctureOther
Patients receive the treatments of Yaotong points penetration
the usual careOther
participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))
standardized acupunctureOther
Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.
| Study group | Role | What they receive |
|---|---|---|
| Yaotong points acupuncture | Experimental | patients under the treatment of Yaotong ponts penetration mode Receives: Other: Yaotong points acupuncture |
| standardized acupuncture | Active comparator | patients under the treatment of standardized acupuncture Receives: Other: standardized acupuncture |
| the usual care | Other | In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)). Receives: Other: the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
Measured: at 0 week, 12 weeks, 24 weeks
Secondary outcomes (3)
Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.
Measured: at 0 week, 12 weeks, 24 weeks
Changes from baseline on short-form 36 health survey (SF-36)
Physical and mental health component summary scores of the medical outcomes
Measured: at 0 week, 12 weeks, 24 weeks
Changes from baseline on Visual Analog Scale at 24 weeks
This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
Measured: at 0 week, 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 posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260284
- Sponsor's protocol ID
- 2014LBP01
- Status last verified
- Dec 2017
- First submitted
- 2 Oct 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luo Y, Yang M, Liu T, Zhong X, Tang W, Guo M, Hu Y. Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial. J Tradit Chin Med. 2019 Aug;39(4):587-598.
PubMed 32186108
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture in Treating Chronic Low-back Pain
- ClinicalTrials.gov ID
- NCT02260284
- Acronym / sponsor ID
- 2014LBP01
- Conditions
- Ankylosing Spondylitis, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 9 Oct 2014 (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 evaluate the efficiency of acupuncture in treating chronic low-back pain
Detailed description
We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yaotong points acupuncture | Experimental | Other: Yaotong points acupuncturepatients under the treatment of Yaotong ponts penetration mode |
| standardized acupuncture | Active comparator | Other: standardized acupuncturepatients under the treatment of standardized acupuncture |
| the usual care | Other | Other: the usual careIn the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with CLBP
- without taking any other medication for the treatment of CLBP in at least 2 last weeks;
- aged from 18 to 50 years;
- without conflict to the written, informed consent signed prior to the enrollment.
Key exclusion criteria (6 listed)
- pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
- complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
- with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
- conditions making treatment difficult (e.g., paralysis, psychoses);
- conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
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 |
|---|---|---|
| Yaotong points acupuncturePatients receive the treatments of Yaotong points penetration | Other | Yaotong points acupuncture |
| the usual careparticipants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)) | Other | the usual care |
| standardized acupuncturePatients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg. | Other | standardized acupuncture |
Primary outcome
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
Time frame: at 0 week, 12 weeks, 24 weeks
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
3 secondary outcomes
Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
Time frame: at 0 week, 12 weeks, 24 weeks
Changes from baseline on short-form 36 health survey (SF-36)
Time frame: at 0 week, 12 weeks, 24 weeks
Changes from baseline on Visual Analog Scale at 24 weeks
Time frame: at 0 week, 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 6 Dec 2017.
- Derived from this study: PubMed 32186108Luo Y, Yang M, Liu T, Zhong X, Tang W, Guo M, Hu Y. Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial. J Tradit Chin Med. 2019 Aug;39(4):587-598.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yaotong points acupuncture and standardized acupuncture in people with Ankylosing Spondylitis and Low Back Pain, run by Chengdu PLA General Hospital at 1 site in China.
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 6 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 Dec 2017. 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 China. 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.
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?
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks (time frame: at 0 week, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260284, which also lists 1 linked publication.
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 Dec 2017.