Clinical trial NCT06102798: Acupuncture for Lumbar Spinal Stenosis
Official title: The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Acupuncture
Neurogenic Claudication
Randomized controlled trial
Lumbar Spinal Stenosis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 420
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnosis criteria of LSS;
2. Aged between 50-80 years;
3. Neurogenic claudication (NC) for more than 3 months;
4. Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
5. The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
6. More severe pain in the buttock and/or leg than in the lower back;
7. Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
8. Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
9. Volunteer to participate the trial and provide written informed consent.

Exclusion Criteria:

1. Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
2. Vascular claudication;
3. Severe heart, pulmonary, liver and/or kidney diseases;
4. Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
5. Unable to complete motorized treadmill test at the speed of 2km/h;
6. Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
7. A history of lumbar surgery;
8. Have received acupuncture treatments in the previous 2 weeks;

Primary outcomes:
measure: The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
timeFrame: Weeks 6 and 18
Secondary outcomes:
measure: The proportion of participants who have at least 50% reduction from baseline in the average scores of buttocks and/or legs pain when walking, standing, or extending the back in the past week as measured by the Number Rating Scale (NRS).
timeFrame: Weeks 6,18 and 30
measure: The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.
timeFrame: Weeks 6 and 18
measure: The change in total walking distance from baseline.
timeFrame: Weeks 6 and 18
measure: The change in the time to first symptoms from baseline.
timeFrame: Weeks 6 and 18
measure: The change in the time to first moderate pain symptom from baseline.
timeFrame: Weeks 6 and 18
measure: The change in final pain intensity from baseline.
timeFrame: Weeks 6 and 18
measure: The change in recovery time from baseline.
timeFrame: Weeks 6 and 18
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline.
timeFrame: Weeks 6,18 and 30
measure: Changes from baseline in the average score of buttocks and/or legs pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week.
timeFrame: Weeks 6,18 and 30
measure: Changes in the average score of lower back pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week from baseline.
timeFrame: Weeks 6,18 and 30
measure: The change from baseline in the index score of European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
timeFrame: Weeks 6,18 and 30
measure: The change from baseline in the domain scores (symptom severity and physical function) of Swiss Spinal Stenosis Questionnaire (SSSQ).
timeFrame: Weeks 6,18 and 30
measure: The proportion of participants who are satisfied with the treatment based on the satisfaction domain of the SSSQ.
timeFrame: Weeks 6,18 and 30
measure: The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
timeFrame: Weeks 6,18 and 30
Other outcomes:
measure: Expectance assessment
timeFrame: Baseline
measure: Blinding assessment
timeFrame: Within 5 minutes after the either treatment in week 6
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, PhD
role: STUDY_CHAIR
References: