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

doi:10.3969/j.issn.2095-4344.0304

Abstract

Abstract:

BACKGROUND: Osteoporotic vertebral compression fracture of the thoracolumbar spine is clinically manifested as back pain. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the preferred treatment methods of this disorder. Our previous results showed that PKP and PVP can effectively reduce the back pain in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine at 6 months post-surgery. Little is documented about longer follow-up for back pain relief after PKP and PVP.

OBJECTIVE: A prospective, non-randomized, controlled trial was design to investigate the long-term and medium-term back pain relief of PKP, PVP and non-surgical treatment in older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine, and analyze the risk factors of back pain.

METHODS: This study will include 900 older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine scheduled to receive treatment in Qinghai Provincial People’s Hospital and assign them to receive PKP, PVP or non-surgical (rehabilitation training and traditional Chinese medicine) treatments (n=300 per treatment method). These included patients were followed up at 1 week, 1, 3, 6, 12, and 24 months. The primary outcome measure of this study is incidence of back pain at 24 months post-surgery. The secondary outcome measures are incidence of back pain at 1 week, 1, 3, 6 and 12 months post-surgery; Visual Analogue Score, Oswestry Disability Index, Japanese Orthopedic Association score, and X-ray morphology of the thoracolumbar spine at baseline (prior to surgery) and at 1 week, 1, 3, 6, 12 and 24 months post-surgery; incidence of adverse events at 1 week, 1, 3, 6, 12 and 24 months post-surgery.Results of 621 older adult patients with osteoporotic vertebral compression fracture of the thoracolumbar spine included in a pilot study revealed that at 6 months post PKP or PVP, Visual Analogue Score and Oswestry Disability Index were significantly decreased compared with prior to surgery, and the incidence of back pain was only 15%. In addition, the risk factors of back pain are bone cement leakage (direction, volume and scope) and adverse reactions (P < 0.05). This study was approved by Medical Ethics Committee of Qinghai Provincial People’s Hospital, China in April 2017 (approval No. RM006G). This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from the participants. The study protocol was designed in March 2017. Patient recruitment and data collection will begin in September 2018 and end in September 2019. Data analysis will begin in October 2021 and end in November 2021.Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016493). Protocol version (1.0).

DISCUSSION: Findings from this study hope to help identify PKP, PVP or non-surgical treatment has the best back pain relief in older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Osteoporosis, Lumbar Vertebrae

CLC Number:

R318

Wang Kai, Li Chun-liang, Zhu Hai-yong, Wang Yu, Zhang Zhi-jin. Three methods for reducing back pain in older adult patients with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a 2-year follow-up non-randomized controlled trial and preliminary results[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(19): 3000-3004.

Figures/Tables 1

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