Authors
»
jalal zaringhalam -More
Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2009
INTERVENTION: acupuncture treatment for chronic low back pain orally baclofen administration.The enrolled subjects randomly were divided to: (1) control (C) group,(2) acupuncture treated (AC) group,(3) baclofen treated (BA) group, and(4) acupuncture plus baclofen treated (BA+AC) group. Treatment procedures for all groups were continued for 5 weeks, which is a standard frequency of treatments for chronic pain . (2)Acupuncture (AC) group: Acupuncture treatment followed the Standard Recommendation in Clinical Trial of Acupuncture (STRICTA) (18). Subjects in this group received acupuncture treatment 2 times a week for 5 weeks by certified acupuncturist. Acupuncture protocol followed the modern approach to acupuncture which incorporates neurohumoral theories of acupuncture treatment mechanism. Each patient, according to major acupuncture references, received needle in following selected acupoints: Shenshu (BL23), Dachangshu (BL25), Panguanshu (BL28) Ciliao (BL32), Kunlum (BL60), huantiao(GB30) and Yanglingquan (GB 34). Aseptic procedure and disposable, stainless, 30‐ gauge needles with electrical stimulation at 4‐6 Hz with pulse duration of 0.5 ms were used (28, 29). Needles (0.2 mm × 40 mm, Seirin Co Ltd) were inserted into the acupoints till the subject felt dull pain or de qi. At each session 10‐12 needles were used and needles were left in place for 20‐25 minutes. (3)Baclofen (BA) group: The 30 mg/day orally administered dose of baclofen is recommended as effective dose in chronic LBP. It is also known that at this dose required for pain relief, no motor impairment was observed (24). (4)Acupuncture plus baclofen treated (BA+AC) group: These patients in A+B treated group received both baclofen (30 mg/day, orally) and, 2 times a week, 20‐25 min acupuncture treatment (according to acupuncture method which mentioned above) for 5 weeks. CONDITION: non‐specific low back pain PRIMARY OUTCOME: pain intensity, which quantified with a 10 cm visual analogue scale (VAS, 0‐100 mm) self‐reported pain disability, which assessed with Roland Morris Questionnaire (RDQ, 0‐24 points). SECONDARY OUTCOME: Nil INCLUSION CRITERIA: (1) lumbar or lumbosacral pain for six months or longer; (2) no radiation of low back pain to other regions; (3) normal neurological signs of lumbosacral nerve including: deep tendon and plantar reflexes, voluntary muscle activities, straight leg raising, and sensory functions; and (4) not receiving any other treatments for more than 3 months before beginning the study.
Epistemonikos ID: 3c5409fdc134100d9f9b08f7c87c0a708e1c3870
First added on: Aug 25, 2024