None listed
Conditions
Brief summary
This is a pragmatic parallel three-armed randomized controlled feasibility study to provide the rationale for and method to be used for a full scale trial. Forty-five participants with chronic low back pain will be recruited from the Dunedin community, and randomized on a 1:1:1 basis to receive usual care plus either 4 sessions (n=15), 7 sessions (n=15), or 10 sessions (n=15) of acupuncture interventions. Primary outcomes include the acceptability of and adherence to different numbers of sessions 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. Secondary outcomes include back specific function, pain intensity and bothersomeness, generic health status, activity disability, and patient satisfaction. Follow up questionnaires will be collected at discharge, and 6 weeks and 12 weeks post randomization. The information obtained from this feasibility study will inform the decision to conduct a full-scale randomized controlled trial to definitively test the dose dependence of acupuncture. Findings will add to the current (limited) body of high quality evidence that is available on the optimal number of sessions of acupuncture in the management of chronic low back pain as well as being clinically relevant to clinicians, researchers, and policy makers.
Interventions
The addition of Traditional Chinese Medicine (TCM) acupuncture to usual care for chronic low back pain.
All participants will be advised to continue their maintenance programme during the intervention period. This may include any pragmatic management (medications, or non-pharmacological therapy e.g. manual therapy) as directed by any health practitioner (e.g. general practitioner, physiotherapist, chiropractor, or osteopath).
In addition to usual care as described above, participants will rec
The addition of Traditional Chinese Medicine (TCM) acupuncture to usual care for chronic low back pain. All participants will be advised to continue their maintenance programme during the intervention period. This may include any pragmatic management (medications, or non-pharmacological therapy e.g. manual therapy) as directed by any health practitioner (e.g. general practitioner, physiotherapist, chiropractor, or osteopath). In addition to usual care as described above, participants will receive either 4 sessions, 7 sessions or 10 sessions of TCM acupuncture: Arm 1 (n=15): 4 sessions of TCM acupuncture over 2 weeks; Arm 2 (n=15): 7 sessions of TCM acupuncture over 3.5 weeks; Arm 3 (n=15): 10 sessions of TCM acupuncture over 5 weeks. TCM acupuncture will be performed by a registered acupuncturist. Each participant will be treated with a combination of local and distant points, including BL 23 (Shenshu) and BL 25 (Dachangshu), which are needled bilaterally, low back Ashi points, BL 40 (Weizhong), and KI 3 (Taixi). Additionally, up to four supplementary acupoints for the possible concomitant buttock or leg pain are allowed, which may include BL 36 (Chengfu), BL37 (Yinmen), BL 54 (Zhibian), GB 30 (Huantiao), GB 31 (Fengshi), BL 57 (Chengshan), and BL 60 (Kunlun). Treatments will be performed twice weekly. Acupuncture will be administered with the participant in a prone position on the treatment couch. Alcohol swabs will be applied to the skin prior to needle insertion if necessary (e.g. immuno-compromised participants). Sterile filiform, single-used needles (0.25 mm x 40 mm, 0.30 mm x 50 mm, and 0.30 mm x 75 mm, Hwato brand, Suzhou, China) will be used to penetrate the skin. The depth of insertion will depend on the point location, the participant’s age and physical condition and response to the needles. Selected acupoints will be stimulated manually by gentle rotation of the needles with lift and thrust until the participant achieves a de qi sensation, and then every 5 minutes to ensure de qi is still present. A maximum of 10 needles will be inserted per session and left in place for approximately 20 minutes. Moxibustion and other interventions (e.g. cupping, scraping, and bloodletting) are excluded from this trial.
Sponsors
University of Otago- School of Physiotherapy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants are eligible if they: (1) are 18 years or older; (2) have a history of low back pain of more than 3 months in the lumbosacral region (below the 12th costal margin and above the inferior gluteal folds) with or without radiating leg pain; (3) report a score of greater than 4 on the modified Roland-Morris disability questionnaire (RDQ) at randomization.
Exclusion criteria
Exclusion criteria include: (1) history of any known serious spinal disorders, including malignancy, neoplasm, infection, congenital spinal deformity, spinal fracture, inflammatory arthritis, spondylolisthesis, ankylosing spondylitis, cauda equine syndrome; (2) history of spinal surgery or currently wait-listed for spinal surgery; (3) previous attendance at a specialised pain clinic or use of morphine (or similar) for low back pain in the past 1 year; (4) unresolved litigation or compensation claim; (5) severe psychological disorders or dementia; (6) use of acupuncture for low back pain in the past 1 year; (7) prolonged use of steroids or current use of anti-coagulant medication; (8) any bleeding disorders; (9) fear of needles; (10) history of any systematic medical conditions precluding participation in this trial (e.g. cardiovascular, liver or kidney diseases, deep vein thrombosis, epilepsy); (11) postpartum, pregnancy or intended pregnancy; (12) unable to communicate in English or Mandarin.
Outcome results
None listed