None listed
Conditions
Brief summary
This will be a two-arm, assessor-blind, non-inferiority feasibility study, Participants (n=30) will be randomly assigned in a 1:1 ratio into two groups. Each group will receive a 4-week course of sensitized-points acupuncture or routine integrative acupuncture (routine acupuncture plus dry cupping), respectively. Treatments will be conducted twice per week. The primary outcome measures include the acceptability of and adherence to different modalities of acupuncture treatment for chronic low back pain, and the feasibility of the recruitment approaches and completion of the outcome measures specific to the trial. This feasibility study will provide the rationale for and method to a randomized controlled trial planned for the future.
Interventions
There will be two groups, each group will use different acupuncture protocols. Experimental treatment will be simple acupuncture treatment on tender acupuncture points. Pain-sensitized points around bilateral BL 23, BL 25, BL 40 will be chosen as the main acupoints. In addition, up to two adjunct acupoints will be chosen from pain-sensitized sites around bilateral Jiaji Points along L1-L5 vertebrae. Treatment will be performed by a formally trained acupuncturist (H.T.), with 5 years' clinical experience. Patients will be asked to maintain a prone position for treatment. After disinfecting skin surface by alcohol swab, selected points will be stimulated by insertion of a sterile, single-use filiform acupuncture needle (Hwato needle, Suzhou, China; 25-40 mm in length; 0.25 mm in diameter). It is generally accepted that needles of 40 mm length should be used in the lumbar area, while needles of 25 mm should be placed in the extremities. Exceptionally, for underweight participants (BMI < 18.5 kg/m²), only 25 mm needles will be administered to ensure safety. After needling, the acupuncturist will continue stimulation to achieve Deqi sensation, which is a sensation of numbness, soreness and distension, indicating the stimulation is effective. Needles will be retained for 30 minutes, during which manual stimulation (lifting-thrusting, and twirling method) will be used every 10 minutes to maintain the sensation of Deqi. Each treatment session will take around 50 minutes. Treatment will be administered at an accredited acupuncture clinic in Dunedin for 8 sessions, twice per week, for four consecutive weeks. Treatment log will be filled by acupuncturist to monitor participants' adherence to the intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
(1) Participants should be adults (aged equal to or more than 18 years old); (2) Have chronic low back pain (cLBP, with or without leg pain) for more than 3 months; (3) The average score of Numeric Pain Rating Scale (NPRS) is more than 3 points out of a maximum 10 points; (4) Agree to sign informed consent.
Exclusion criteria
Participants will be excluded if they report any of the following conditions: (1) Serious spinal disorders including malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression; (2) Scheduled surgery; (3) Received acupuncture in the last 4 weeks; (4) Serious internal disorders: respiratory, circulatory, endocrine, system diseases, etc; (5) Serious mental illness that have a restricted ability to make independent decisions about their participation; (6) Unable to communicate in English or Chinese; (7) Clotting disorders, or taking anticoagulant agent; (8) Current or scheduled pregnancy, lactation period.