AcupunctureNCT04328428
The Evaluation of Single Acupoint Therapy to Acute Low Back Pain
A study testing acupuncture in people with Acupuncture and Acute Low Back Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Low back pain is the leading course of disability , affecting patients' health and work. Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Acute Low Back Pain
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2020to 12 Feb 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- low back pain,duration < 1 month
- accept subject consent
Who cannot join
- without X ray or MRI image
- severe trauma , fracture or spondylosis found from image ,progression neurological symptoms suspected from central nerve system, rheumatic disease, fever or infection is suspected ,weight or cancer history , pregnancy and psychiatric disorder or not able to communication .
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dept of Chinese medicine, Chang Gung Memorial Hospital
Taoyuan
Ko-Hung Lee, MD, +886-3-3196200 ext. 2613, greglgc@cgmh.org
Yuan-Xin Lai, MD, +886-3-3196200 ext. 2613, u9802401@cmu.edu.tw
About this study
Low back pain is the leading course of disability , affecting patients' health and work.
Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type.
Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pain is still unclear.
Therefore, the aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
Read the detailed description
Low back pain is the leading course of disability , affecting patients' health and work. According to the study in 2013, 8.9 percent people of the world experienced over three months low back pain.
Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type.
Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pian is still unclear.
Therefore, the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
The investigators would like to compare the efficacy of the modified Bladder 40 (BL40) acupuncture to single acupoint through statistical analysis.
The investigators expect that all group will alleviate low back pain. However, treatment group will have statistical difference compared with control groups.
The aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
- Conditions
- Acupuncture, Acute Low Back Pain
- Being tested
- acupuncture
- Keywords
- acute low back pain, BL40, Extra Meridian 32 (EM32), acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Use one acupuncture needle insert in a acupoint.
| Study group | Role | What they receive |
|---|---|---|
| (A)modified BL40 acupuncture | Experimental | modified BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain. Receives: Other: acupuncture |
| (B)EM32 acupuncture | Active comparator | EM32 acupuncture Participants receive EM32 acupuncture once on the opposite site. Receives: Other: acupuncture |
| (C)BL40 acupuncture | Active comparator | BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain measurement
use Visual Analogue Scale to measure pain intensity and algometer to measure pain threshold The minimum of Visual Analogue Scale is 0 and maximum values is 10. The higher Visual Analogue Scale mean a worse outcome . Newton is used to measure pain threshold. The higher pain threshold scores mean a better outcome .
Measured: 30 minutes
range of motion measurement
measure the range of motion when lumbar extension and flexion
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start28 Mar 2020 (estimated)
- Primary completion12 Feb 2021 (estimated)
- Study completion12 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- three groups randomly:experiment group and two control groups. Patients in experiment group receive modified BL40 acupuncture. Control group one receives EM32 acupuncture and control group two receives BL40 acupuncture
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ko-Hung Lee, MD, Study chair, ChangGung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328428
- Sponsor's protocol ID
- 202000002A3
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.
PubMed 26063472Hong J, Reed C, Novick D, Happich M. Costs associated with treatment of chronic low back pain: an analysis of the UK General Practice Research Database. Spine (Phila Pa 1976). 2013 Jan 1;38(1):75-82. doi: 10.1097/BRS.0b013e318276450f.
PubMed 23038621Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
PubMed 16595438Asmundson GJG, Norton RG, Allerdings MD. Fear and avoidance in dysfunctional chronic back pain patients. Pain. 1997 Feb;69(3):231-236. doi: 10.1016/S0304-3959(96)03288-5.
PubMed 9085296Kent PM, Keating JL. Can we predict poor recovery from recent-onset nonspecific low back pain? A systematic review. Man Ther. 2008 Feb;13(1):12-28. doi: 10.1016/j.math.2007.05.009. Epub 2007 Jul 19.
PubMed 17658288Vas J, Aranda JM, Modesto M, Benitez-Parejo N, Herrera A, Martinez-Barquin DM, Aguilar I, Sanchez-Araujo M, Rivas-Ruiz F. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012 Sep;153(9):1883-1889. doi: 10.1016/j.pain.2012.05.033. Epub 2012 Jul 4.
PubMed 22770838
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Single Acupoint Therapy to Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT04328428
- Acronym / sponsor ID
- 202000002A3
- Conditions
- Acupuncture, Acute Low Back Pain
- Keywords
- acute low back pain, BL40, Extra Meridian 32 (EM32), acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Mar 2020 (estimated)
- Primary completion
- 12 Feb 2021 (estimated)
- Study completion
- 12 Feb 2021 (estimated)
- First posted
- 31 Mar 2020 (actual)
- 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.
Low back pain is the leading course of disability , affecting patients' health and work.
Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type.
Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pain is still unclear.
Therefore, the aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
Detailed description
Low back pain is the leading course of disability , affecting patients' health and work. According to the study in 2013, 8.9 percent people of the world experienced over three months low back pain.
Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type.
Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pian is still unclear.
Therefore, the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
The investigators would like to compare the efficacy of the modified Bladder 40 (BL40) acupuncture to single acupoint through statistical analysis.
The investigators expect that all group will alleviate low back pain. However, treatment group will have statistical difference compared with control groups.
The aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- three groups randomly:experiment group and two control groups. Patients in experiment group receive modified BL40 acupuncture. Control group one receives EM32 acupuncture and control group two receives BL40 acupuncture
| Arm | Type | Receives |
|---|---|---|
| (A)modified BL40 acupuncture | Experimental | Other: acupuncturemodified BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain. |
| (B)EM32 acupuncture | Active comparator | Other: acupunctureEM32 acupuncture Participants receive EM32 acupuncture once on the opposite site. |
| (C)BL40 acupuncture | Active comparator | Other: acupunctureBL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low back pain,duration < 1 month
- accept subject consent
Key exclusion criteria (2 listed)
- without X ray or MRI image
- severe trauma , fracture or spondylosis found from image ,progression neurological symptoms suspected from central nerve system, rheumatic disease, fever or infection is suspected ,weight or cancer history , pregnancy and psychiatric disorder or not able to communication .
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 |
|---|---|---|
| acupunctureUse one acupuncture needle insert in a acupoint. | Other | (A)modified BL40 acupuncture, (B)EM32 acupuncture, (C)BL40 acupuncture |
Primary outcome
pain measurement
Time frame: 30 minutes
use Visual Analogue Scale to measure pain intensity and algometer to measure pain threshold The minimum of Visual Analogue Scale is 0 and maximum values is 10. The higher Visual Analogue Scale mean a worse outcome . Newton is used to measure pain threshold. The higher pain threshold scores mean a better outcome .
range of motion measurement
Time frame: 30 minutes
measure the range of motion when lumbar extension and flexion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Background: PubMed 26063472Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.
- Background: PubMed 23038621Hong J, Reed C, Novick D, Happich M. Costs associated with treatment of chronic low back pain: an analysis of the UK General Practice Research Database. Spine (Phila Pa 1976). 2013 Jan 1;38(1):75-82. doi: 10.1097/BRS.0b013e318276450f.
- Background: PubMed 16595438Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
- Background: PubMed 9085296Asmundson GJG, Norton RG, Allerdings MD. Fear and avoidance in dysfunctional chronic back pain patients. Pain. 1997 Feb;69(3):231-236. doi: 10.1016/S0304-3959(96)03288-5.
- Background: PubMed 17658288Kent PM, Keating JL. Can we predict poor recovery from recent-onset nonspecific low back pain? A systematic review. Man Ther. 2008 Feb;13(1):12-28. doi: 10.1016/j.math.2007.05.009. Epub 2007 Jul 19.
- Background: PubMed 22770838Vas J, Aranda JM, Modesto M, Benitez-Parejo N, Herrera A, Martinez-Barquin DM, Aguilar I, Sanchez-Araujo M, Rivas-Ruiz F. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012 Sep;153(9):1883-1889. doi: 10.1016/j.pain.2012.05.033. Epub 2012 Jul 4.
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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.
Ko-Hung Lee, MD study chair
ChangGung Memorial 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 acupuncture in people with Acupuncture and Acute Low Back Pain, run by Chang Gung Memorial 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 2 inclusion and 2 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 8 Apr 2020. 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. 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 Yuan-Xin Lai, MD (+886-3-3196200 ext. 2613, u9802401@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain measurement (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 NCT04328428, which also lists 6 linked publications.
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 8 Apr 2020.