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RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 2  |  Page : 59-65

Three methods for reducing back pain in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a non-randomized controlled trial with 2-year follow-up and preliminary results


Qinghai Provincial People’s Hospital, Xining, Qinghai Province, China

Correspondence Address:
Chun-Liang Li
Qinghai Provincial People’s Hospital, Xining, Qinghai Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.235149

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Background and objectives: Osteoporotic vertebral compression fracture of the thoracolumbar spine manifests clinically as back pain. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the preferred treatment methods for this disorder. Our previous studies have shown that both procedures effectively reduce back pain at 6 months post-surgery in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine. Little is documented about longer-term pain relief after PKP and PVP. The aim of this prospective, single-center, non-randomized, controlled trial is to investigate long-term and medium-term back pain relief after PKP, PVP, and non-surgical treatment of this condition and to analyze risk factors for ongoing back pain. Design: A prospective, single-center, non-randomized, controlled trial. Methods: This study will include 900 patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine scheduled to receive treatment at Qinghai Provincial People’s Hospital. Patients will be assigned to receive PKP, PVP, or nonsurgical treatment (rehabilitation and traditional Chinese medicine; n = 300 per treatment method). Patients will have follow-up evaluation at 1 week and 1, 3, 6, 12, and 24 months. Outcome measures and preliminary results: The primary outcome measure is the prevalence of back pain 24 months post-surgery. Secondary outcome measures are prevalence of back pain at other time points; Visual Analogue Score, Oswestry Disability Index, Japanese Orthopedic Association score, and X-ray morphology before surgery and at all postoperative time points; and incidence of adverse events at each postoperative time point. A pilot study of 621 patients with osteoporotic vertebral compression fracture of the thoracolumbar spine revealed that Visual Analogue Score and Oswestry Disability Index were significantly lower 6 months postoperatively than prior to PKP or PVP, with only 15% of patients having ongoing back pain. Risk factors for back pain were bone cement leakage (direction, volume, and scope) and adverse reactions (P < 0.05). This study’s findings will help clarify the optimal treatment for back pain relief in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine. Ethics and dissemination: The study protocol was approved by Medical Ethics Committee, Qinghai Provincial People’s Hospital of China in April 2017 (approval No. RM006G). This study will be performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from each patient. The study protocol was designed in March 2017. Patient recruitment and data collection will begin in September 2018. Patient recruitment will end in September 2019. Data analysis will be performed in October 2021. The whole study will end in November 2021. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016493). Protocol version: 1.0.


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