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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline. | Baseline, week 1-4, week 5-8, week 9-20, week 21-32 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Number Rating Scale (NRS) from baseline. | Baseline, week1-8, week 9-20, week 21-32 | |
| The change of Self-paced Walking test (SPWT) from baseline to week 8. | Baseline, week 8. | |
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Inclusion Criteria:
Participants who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Science | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27852717 | Derived | 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. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 9, 2019 | |
| Reset | Jun 14, 2019 | |
| Release | Jan 16, 2020 | |
| Reset | Jan 29, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 9, 2019 | Jun 14, 2019 | |||
| Jan 16, 2020 |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| placebo needle | Device | 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. |
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| The change of Swiss Spinal Stenosis Questionnaire (SSSQ) from baseline. |
| 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. | Baseline. |
| Jan 29, 2020 |