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Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis

Primary Purpose

Degenerative Lumbar Spinal Stenosis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

placebo needle

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis focused on measuring degenerative lumbar spinal stenosis, acupuncture, randomized controlled trial

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Guang'anmen Hospital, China Academy of Chinese Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture group

Placebo needle group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.

Secondary Outcome Measures

The change of Number Rating Scale (NRS) from baseline.

The change of Self-paced Walking test (SPWT) from baseline to week 8.

The change of Swiss Spinal Stenosis Questionnaire (SSSQ) from baseline.

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.

Full Information

NCT ID

NCT02644746

First Posted

December 27, 2015

Last Updated

February 13, 2019

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02644746

Brief Title

Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis

Official Title

Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis: Protocol for a Randomized Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Lumbar Spinal Stenosis

Keywords

degenerative lumbar spinal stenosis, acupuncture, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo needle group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

placebo needle

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

The change of Number Rating Scale (NRS) from baseline.

Time Frame

Baseline, week1-8, week 9-20, week 21-32

Title

The change of Self-paced Walking test (SPWT) from baseline to week 8.

Time Frame

Baseline, week 8.

Title

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

Title

The expectations that acupuncture might help patients DLSS will be recorded at baseline (scale).

Description

Time Frame

Baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhishun Liu

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Guang'anmen Hospital, China Academy of Chinese Medical Science

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Individual participant data (IPD) will be preserved, when the paper submitted, if the journal ask IPD, it will be uploaded as a supplement.

Citations:

PubMed Identifier

27852717

Citation

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.

Results Reference

derived

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Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis

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