A Randomized Controlled Double-blind Study of Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in the Treatment of Chronic Non-specific Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Lumbar JOA Scale
Study Overview
Brief Summary
Carry out a randomized controlled double-blind study, the acupuncture combined with placebo application group was compared with the acupuncture combined with Yanqing Zhitong ointment acupoint application group, 86 patients with chronic non-specific low back pain were included.
Detailed Description
Treatment group(acupuncture combined with Yanqing Zhitong ointment acupoint sticking) Acupoints for manual acupuncture:Weizhong(BL40), Shenshu(BL23) ,Dachangshu(BL25) ,Geshu(BL17) ,Kunlun(BL60) ,Ashi point Acupoints for sticking:According to the location of pain, we select acupuncture points along the meridian
Controal group(acupuncture combined with placebo application) Interventions are same as Treatment Group.
Both groups were treated 3 times a week for 4 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnostic of non-specific low back pain
- •Aage from 18 to 65
- •Last for at least 12 weeks
- •VAS between 4 and 7
- •No other treatment in the past 3 months
- •Patients with no partial skin damage
- •No other relevant treatment methods
- •Sign informed consent and informed consent
Exclusion Criteria
- •Pregnant women
- •Suffer from diabetes
- •With skin ulcers or contusion wounds
- •Past history of severe allergy to transdermal preparations
- •Complicated with serious diseases
Outcomes
Primary Outcomes
Lumbar JOA Scale
Time Frame: Change from baseline JOA at 4weeks
The JOA scale for low back pain consists of the patient's subjective symptoms (0-9 points), clinical signs (0-6 points), daily activity limitation (0-24 points) and bladder function (normal 0 points, slight loss of control-3 points, severe loss of control) -6 points) Four parts, a total score of 29 points. The total score reflects the symptoms and dysfunction of low back pain, and the score indicates the severity of the dysfunction.
Secondary Outcomes
- Oswestry Dysfunction Index (ODI)(Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks)
- McGill Pain Questionnaire (MPQ)(Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks)
- Lumbar JOA Scale(Change from baseline JOA at 2weeks and follow up 2weeks)
- Visual Analog Scoring (VAS)(Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks)
- Tenderness threshold(Change from baseline tenderness threshold at 2weeks ,4 weeks and follow up 2weeks)
- Averaged electromyography, AEMG(Change from baseline AEMG at 2weeks ,4 weeks and follow up 2weeks)
- Concise health scale SF-36(Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks)