Degenerative Lumbar Spinal StenosisNCT02644746
Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis
A study testing acupuncture in people with Degenerative Lumbar Spinal Stenosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective for DLSS but the evidence is poor. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jun 2018
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows:
- Pain in the low back, buttock, and/or lower extremity with standing, walking and/or spinal extension. (Using NRS questionnaire to measure pain symptoms, and pain measured by NRS ≥ 4.)
- Roland-Morris score of at least 7.
- Mild-moderate-severe lumbar central canal spinal stenosis identified by MRI or CT scan.
- Lower extremity symptoms consistent with neurogenic claudication.
- Age 50 to 80 years old.
- Signed the consent and take part in this trial of his/her willing.
Who cannot join
- Congenital stenosis of vertebral canal, serious indications of DLSS (such as segmental muscular atrophy, bowel and bladder disturbances), spinal nerve root canal stenosis, lumbar spondylolysis, lumbar tuberculosis, lumbar vertebral tumors, and vertebral body compression fracture.
- Spinal instability requiring surgery.
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction.
- Participants who have cognitive impairment that may render the subject unable to give informed consent or provide accurate data.
- Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
- Acupuncture within the past 30 days.
- Administered pain control drugs during the week prior to the baseline assessment (e.g.,non-steroidal anti-inflammatory drugs or herbal anti-inflammatory agents).
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing Municipality, 100053
About this study
Official title: Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis: Protocol for a Randomized Placebo-controlled Trial
Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients. A total of 80 participants meet prior inclusion criteria will be recruited. The participants will be allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly. Twenty-four treatments will be provided over 8 weeks. The primary change of Modified Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and 32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and non-parametric test. The investigators hope the result of this trial will clarify the value of acupuncture for DLSS and help clinicians make proper decisions.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- acupuncture, placebo needle
- Keywords
- degenerative lumbar spinal stenosis, acupuncture, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57), Taixi (KI3) acupoints will be used. For bilateral Dachangshu (BL 25), the needle will be inserted vertically at approximately 40-70 mm until participants got a electric shock feeling downward to calves, then the needle should be elevated up 2 mm, without rotating or lifting. For other four acupoints (BL23, BL40, BL57, KI3), they will be inserted 10 to 15 mm in depth with three times light amplitude rotation and lift to induce a sensation of soreness. The manipulations will be performed 3 times in total during 1 session (every 10 min). There are 24 treatment sessions after baseline, 3 times a week, and the patients will undergo a 30-min treatment each session.
placebo needleDevice
Acupuncturists will use blunt tip needles (Huatuo, Suzhou, China) that cannot penetrate skin and stimulate deep tissues, and the thrusting and twisting motions will be used by acupuncturists to simulate the treatment and blind the patients. Each placebo needle consists of four parts: needle handle, needle body, blunt tip and adhesive pad. The chosen of acupoints, treatment duration, and frequency of sessions will be the same as the acupuncture group. To guarantee blinding, the investigators will make appointments with each participant on alternate days to prevent crosstalk among groups.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture has a long time used for chronic pain including low back pain, sciatica, and other pain related to spina via stimulating specific acupuncture points. Receives: Device: acupuncture |
| Placebo needle group | Placebo comparator | The placebo needle using in this trial will be unpenetrated needles. Based on our previous research, the placebo needle is a valid control for acupuncture research and may eliminate the placebo effect of acupuncture. Receives: Device: placebo needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.
Measured: Baseline, week 1-4, week 5-8, week 9-20, week 21-32
Secondary outcomes (4)
The change of Number Rating Scale (NRS) from baseline.
Measured: Baseline, week1-8, week 9-20, week 21-32
The change of Self-paced Walking test (SPWT) from baseline to week 8.
Measured: Baseline, week 8.
The change of Swiss Spinal Stenosis Questionnaire (SSSQ) from baseline.
Measured: Baseline, week 1-4, week 5-8, week 9-20, week 21-32
The expectations that acupuncture might help patients DLSS will be recorded at baseline (scale).
This expectation scale include four items, including belief "Do you think acupuncture can work?", expectation "Do you think acupuncture may help your "DLSS", preference 1"Which treatment do you prefer?", and preference2 "Did you get your treatment preference?" In fact, this is partial domain of "participants baseline information", which will be recorded at baseline. The investigators want to explore the relationship between expectation degree and primary outcome via linear regression.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionJun 2018
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 Degenerative Lumbar Spinal StenosisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Zongshi, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644746
- Sponsor's protocol ID
- 2015EC114
- Status last verified
- Feb 2019
- First submitted
- 27 Dec 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Individual participant data (IPD) will be preserved, when the paper submitted, if the journal ask IPD, it will be uploaded as a supplement.
Publications
Qin Z, Ding Y, Wu J, Zhou J, Yang L, Liu X, Liu Z. Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial. BMJ Open. 2016 Nov 16;6(11):e012821. doi: 10.1136/bmjopen-2016-012821.
PubMed 27852717
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis: Protocol for a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02644746
- Acronym / sponsor ID
- 2015EC114
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Keywords
- degenerative lumbar spinal stenosis, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Jan 2016 (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.
Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients. A total of 80 participants meet prior inclusion criteria will be recruited. The participants will be allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly. Twenty-four treatments will be provided over 8 weeks. The primary change of Modified Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and 32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and non-parametric test. The investigators hope the result of this trial will clarify the value of acupuncture for DLSS and help clinicians make proper decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: acupunctureAcupuncture has a long time used for chronic pain including low back pain, sciatica, and other pain related to spina via stimulating specific acupuncture points. |
| Placebo needle group | Placebo comparator | Device: placebo needleThe placebo needle using in this trial will be unpenetrated needles. Based on our previous research, the placebo needle is a valid control for acupuncture research and may eliminate the placebo effect of acupuncture. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows:
- Pain in the low back, buttock, and/or lower extremity with standing, walking and/or spinal extension. (Using NRS questionnaire to measure pain symptoms, and pain measured by NRS ≥ 4.)
- Roland-Morris score of at least 7.
- Mild-moderate-severe lumbar central canal spinal stenosis identified by MRI or CT scan.
- Lower extremity symptoms consistent with neurogenic claudication.
Key exclusion criteria (7 listed)
- Congenital stenosis of vertebral canal, serious indications of DLSS (such as segmental muscular atrophy, bowel and bladder disturbances), spinal nerve root canal stenosis, lumbar spondylolysis, lumbar tuberculosis, lumbar vertebral tumors, and vertebral body compression fracture.
- Spinal instability requiring surgery.
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction.
- Participants who have cognitive impairment that may render the subject unable to give informed consent or provide accurate data.
- Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
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 |
|---|---|---|
| acupunctureShenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57), Taixi (KI3) acupoints will be used. For bilateral Dachangshu (BL 25), the needle will be inserted vertically at approximately 40-70 mm until participants got a electric shock feeling downward to calves, then the needle should be elevated up 2 mm, without rotating or lifting. For other four acupoints (BL23, BL40, BL57, KI3), they will be inserted 10 to 15 mm in depth with three times light amplitude rotation and lift to induce a sensation of soreness. The manipulations will be performed 3 times in total during 1 session (every 10 min). There are 24 treatment sessions after baseline, 3 times a week, and the patients will undergo a 30-min treatment each session. | Device | Acupuncture group |
| placebo needleAcupuncturists will use blunt tip needles (Huatuo, Suzhou, China) that cannot penetrate skin and stimulate deep tissues, and the thrusting and twisting motions will be used by acupuncturists to simulate the treatment and blind the patients. Each placebo needle consists of four parts: needle handle, needle body, blunt tip and adhesive pad. The chosen of acupoints, treatment duration, and frequency of sessions will be the same as the acupuncture group. To guarantee blinding, the investigators will make appointments with each participant on alternate days to prevent crosstalk among groups. | Device | Placebo needle group |
Primary outcome
The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.
Time frame: Baseline, week 1-4, week 5-8, week 9-20, week 21-32
4 secondary outcomes
The change of Number Rating Scale (NRS) from baseline.
Time frame: Baseline, week1-8, week 9-20, week 21-32
The change of Self-paced Walking test (SPWT) from baseline to week 8.
Time frame: Baseline, week 8.
The change of Swiss Spinal Stenosis Questionnaire (SSSQ) from baseline.
Time frame: Baseline, week 1-4, week 5-8, week 9-20, week 21-32
The expectations that acupuncture might help patients DLSS will be recorded at baseline (scale).
Time frame: Baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 27852717Qin Z, Ding Y, Wu J, Zhou J, Yang L, Liu X, Liu Z. Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial. BMJ Open. 2016 Nov 16;6(11):e012821. doi: 10.1136/bmjopen-2016-012821.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be preserved, when the paper submitted, if the journal ask IPD, it will be uploaded as a supplement.
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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.
Zhishun Liu study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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 Degenerative Lumbar Spinal Stenosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 15 Feb 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline. (time frame: Baseline, week 1-4, week 5-8, week 9-20, week 21-32). 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 NCT02644746, 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 15 Feb 2019.