Clinical trial NCT03784729: Efficacy of Acupuncture for Lumbar Spinal Stenosis
Official title: Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Intermittent Claudication
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 196
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: Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain, women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this disease are soreness and pain in the low back, gluteal region and posterior region of thighs which can be relieved after resting or changing posture. Being accompanied with gradually aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia and numbness in lateral lower legs and feet, additionally, few patients may have bowel and bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS), treatment options comprise surgical therapy, epidural steroid injections and physical therapy and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical therapy is with insufficient evidence. According to a systematic review and recent studies, acupuncture may improve the symptoms of patients and their quality of life, however, there is a lack of placebo-controlled and large sample sized study.


Eligibility criteria: Inclusion Criteria:

* Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or computed tomography (CT)-based radiological diagnosis of central sagittal diameter stenosis of the lumbar spinal canal;
* Have neurogenic intermittent claudication (IC) characterized by progressive pain, numbness, weakness, and tingling of the buttocks and/or legs when standing or walking or with extension of the back, which are relieved upon sitting, lying down, or bending forward \[22\]; they must always walk in flexion or hunchback posture;
* Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or extending the back, as measured using the Numerical Rating Scale (NRS);
* Have pain in the buttock and/or leg that is more severe than their pain in the lower back;
* Have a Roland-Morris score of at least 7;
* Have received a MRI or CT scan within 1 year that showed the anterior posterior diameter of the canal was ≤12 mm;
* Are aged 50-80 years;
* Have provided signed consent and exhibit willingness to participate in the trial.

Exclusion Criteria:

* Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g., segmental muscular atrophy, bowel and bladder disturbances), spinal instability requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral body/vertebral stenosis segment compression fracture;
* Severe vascular, pulmonary, or coronary artery disease with limited lower extremities motility;
* Clinical comorbidities that could interfere with the collection of data related to pain and walking function such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, and dementia;
* Cognitive impairment, such that they are unable to understand the content of the assessment scales or provide accurate data;
* A history of lumbar surgery;
* Plans to become pregnant within 12 months or are already pregnant;
* Received acupuncture treatments for DLSS within the previous 30 days;
* Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower extremities instead of pain.

Primary outcomes:
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
timeFrame: week 6
Secondary outcomes:
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
timeFrame: week 18
measure: The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline
timeFrame: week 30
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 6
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 18
measure: The proportion of participants with at least 30% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 30
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 6
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 18
measure: The proportion of participants with at least 50% reduction from baseline in the Modified Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: week 30
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
timeFrame: week 6
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
timeFrame: week 18
measure: Changes in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back as measured by the Number Rating Scale (NRS) in the previous 1 week from baseline
timeFrame: week 30
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 6
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 18
measure: At least 30% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 30
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 6
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 18
measure: At least 50% reductions from baseline in the average pain scores for the buttocks and/or legs when walking, standing, or extending the back, as measured by the Number Rating Scale (NRS) for the previous 1 week
timeFrame: week 30
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
timeFrame: week 6
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
timeFrame: week 18
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in symptom severity domain from baseline
timeFrame: week 30
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
timeFrame: week 6
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
timeFrame: week 18
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in physical function domain from baseline
timeFrame: week 30
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
timeFrame: week 6
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
timeFrame: week 18
measure: The changed mean score of Swiss Spinal Stenosis Questionnaire (SSSQ) in satisfaction domain from baseline
timeFrame: week 30
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 6
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 18
measure: The proportion of participants with somewhat satisfied in the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 30
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 6
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 18
measure: The proportion of participants with very satisfied based on the satisfaction domain of Swiss Spinal Stenosis Questionnaire (SSSQ)
timeFrame: week 30
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: week 6
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: week 18
measure: The change of Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: week 30
Other outcomes:
measure: The proportion of patients who have expectancy of acupuncture
timeFrame: Baseline
measure: The proportion of patients with successful blinding
timeFrame: Week 6
measure: Incidence of adverse events
timeFrame: week 1 to week 30
Locations:
city: Beijing
country: China
facility: Guang An Men Hospital
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Yan Liu, Master
role: STUDY_DIRECTOR
References:
citation: Zhou J, Liu S, Sun Y, Wang W, Liu Z. Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial. Trials. 2020 Jul 25;21(1):679. doi: 10.1186/s13063-020-04612-8.