Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Device: acupuncture; Device: placebo needle

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen Hospital, China Academy of Chinese Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; 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.	Device: acupuncture; 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 Comparator: Placebo needle group; 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.	Device: placebo needle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: Zhishun Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 27, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: randomized controlled trial; acupuncture; degenerative lumbar spinal stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2015EC114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.