Schulz Craig A, Hondras Maria A, Evans Roni L, Gudavalli Maruti R, Long Cynthia R, Owens Edward F, Wilder David G, Bronfort Gert
Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 West 84th Street, Bloomington, MN 55431, USA.
Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8.
Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.
METHODS/DESIGN: This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.
Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures.
ClinicalTrials.gov NCT00494065.
与背部相关的腿部疼痛（BRLP）是腰痛（LBP）的一种常见变体，终生患病率估计高达40%。BRLP通常会导致残疾，与单纯性LBP相比，它导致更多的工作损失、复发和更高的成本，并且更常导致手术，重度BRLP患者的终生发病率为10%，而LBP患者为1 - 2%。在美国，一半患有背部相关疾病的人寻求补充和替代医学（CAM）治疗，其中最常见的是脊椎按摩治疗。虽然有初步证据表明脊椎按摩脊柱手法治疗对BRLP患者有益，但目前尚无足够证据评估这种治疗的有效性。
方法/设计：本研究是一项双中心、前瞻性、平行组、观察者盲法随机临床试验（RCT）。总共192名研究患者将分别从明尼苏达州双子城（n = 122）以及爱荷华州和伊利诺伊州的四城地区（n = 70）招募到WHCCS和PCCR的研究诊所。该研究比较两种干预措施：脊椎按摩脊柱手法治疗（SMT）加家庭锻炼计划（HEP）与单独的HEP（最小干预对照），用于治疗亚急性或慢性与背部相关的腿部疼痛患者。
与背部相关的腿部疼痛（BRLP）是普遍存在的背痛病症中一种代价高昂且常常导致残疾的变体。随着医疗保健成本持续攀升，寻找副作用少的有效治疗方法至关重要。虽然SMT是LBP患者最常寻求的CAM治疗方法，但仅有少量虽有前景但尚不充分的研究支持其用于BRLP患者。本研究旨在通过进行首个全面的RCT来填补LBP文献中的关键空白，该RCT使用重要的以患者为导向的和客观的生物力学结局指标，评估脊椎按摩SMT对亚急性或慢性BRLP患者的疗效。
ClinicalTrials.gov NCT00494065
