Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Degenerative Lumbar Spinal Stenosis

Treatments: Device: placebo needle; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02644746

2015EC114

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows:

1. 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.)
2. Roland-Morris score of at least 7.
3. Mild-moderate-severe lumbar central canal spinal stenosis identified by MRI or CT scan.
4. Lower extremity symptoms consistent with neurogenic claudication.
5. Age 50 to 80 years old.
6. Signed the consent and take part in this trial of his/her willing.

Exclusion criteria

1. 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.
2. Spinal instability requiring surgery.
3. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction.
4. Participants who have cognitive impairment that may render the subject unable to give informed consent or provide accurate data.
5. Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
6. Acupuncture within the past 30 days.
7. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Acupuncture group

Experimental group

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.

Treatment:

Device: acupuncture

Placebo needle group

Placebo Comparator group

Description:

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.

Treatment:

Device: placebo needle