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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
For the bilateral" BL25", sterile disposable steel needles (Hwato, China; 0.3 mm×75 mm) will be inserted through adhesive pads to a depth of 50-70mm until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Hwato, China; 0.3 mm×40 mm) will be inserted through adhesive pads to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi.
For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
RECRUITINGThe proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the motorized treadmill test (MTT).
Time frame: Weeks 6 and 18
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).
Number Rating Scale (NRS) is a brief scale assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain. The minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Time frame: Weeks 6,18 and 30
The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the MTT.
Time frame: Weeks 6 and 18
The change in total walking distance from baseline.
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the MTT.
Time frame: Weeks 6 and 18
The change in the time to first symptoms from baseline.
The time to first symptoms refers to the time when one or both legs experience pain, fatigue, abnormal sensations, and/or tightness during the MTT.
Time frame: Weeks 6 and 18
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The change in the time to first moderate pain symptom from baseline.
The first moderate pain symptom refers to NRS score ≥4. Number Rating Scale (NRS) is a brief scale assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain. The minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Time frame: Weeks 6 and 18
The change in final pain intensity from baseline.
When the subject reached their maximum distance, they were asked their NRS score, this was recorded as final pain intensity. Number Rating Scale (NRS) is a brief scale assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain. The minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Time frame: Weeks 6 and 18
The change in recovery time from baseline.
Recovery time refers to time to return to baseline pain intensity after MTT.
Time frame: Weeks 6 and 18
The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline.
Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24. higher scores indicate more severe symptoms.
Time frame: Weeks 6,18 and 30
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.
Number Rating Scale (NRS) is a brief scale assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain. The minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Time frame: Weeks 6,18 and 30
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.
Number Rating Scale (NRS) is a brief scale assessing pain completed by patients themselves. The scores of NRS ranges from 0 to 10 with 11 grades and higher scores indicates greater pain. The minimum value is 0 points, and the maximum value is 10 points. The higher the score, the worse the result.
Time frame: Weeks 6,18 and 30
The change from baseline in the index score of European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
The European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) includes five dimensions: Mobility, Self Care, Usual Activities, Pain or Discomfort, and Anxiety or Depression. Each dimension also includes five levels: no difficulty, slight difficulty, moderate difficulty, severe difficulty, and extreme difficulty. Each dimension has a high score of 5 and a low score of 1. The EQ-5D-5L index score can be calculated based on the choices made by the respondents on the five dimensions and five levels in the questionnaire.
Time frame: Weeks 6,18 and 30
The change from baseline in the domain scores (symptom severity and physical function) of Swiss Spinal Stenosis Questionnaire (SSSQ).
SSSQ include three domains, which are symptom severity, physical function and satisfaction with the treatment. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms. The physical function domain assesses walking distance and ability to walk for pleasure, shopping, and getting around the house or apartment and from the bathroom to the bedroom. This domain has five questions with scores ranging from 1 to 4, and higher scores indicate less satisfaction. For satisfactory domain, patients scoring 2.5 points or less are regarded as satisfied with the treatment.
Time frame: Weeks 6,18 and 30
The proportion of participants who are satisfied with the treatment based on the satisfaction domain of the SSSQ.
SSSQ include three domains, which are symptom severity, physical function and satisfaction with the treatment. Six questions in the symptom severity domain assess back, buttocks, legs or feet pain, pain frequency, numbness, weakness with scores ranging from 1 to 5 while one question assesses balance with scores ranging from 1, 3 and 5 and higher scores indicating worse symptoms. The physical function domain assesses walking distance and ability to walk for pleasure, shopping, and getting around the house or apartment and from the bathroom to the bedroom. This domain has five questions with scores ranging from 1 to 4, and higher scores indicate less satisfaction. For satisfactory domain, patients scoring 2.5 points or less are regarded as satisfied with the treatment.
Time frame: Weeks 6,18 and 30
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
HADS is validated and standardized for measuring the state of anxiety and depression. HADS has 2 subscales with 14 items (7 items each), and a total score of 0 to 21 with 0 to 3 for each item.
Time frame: Weeks 6,18 and 30