Protocol for systematic review and meta-analysis on the efficacy and safety of acupuncture for residual low back pain after percutaneous kyphoplasty in patients with osteoporotic vertebral compression fracture

Description of the condition

As the ageing society continues to rapidly develop, the incidence of osteoporosis (OP) is also increasing annually, and its detrimental effects are worsening.1 OP not only leads to a decrease in bone mass and degeneration of bone structure, but it also increases bone fragility and reduces bone strength.2 Consequently, older patients face an elevated risk of fractures, even with minor or no external force.3 The most common complication is osteoporotic vertebral compression fracture (OVCF), which is closely associated with race, gender and age.4 OVCF often results in persistent low back pain that hampers mobility and impairs normal function, significantly reducing overall quality of life.5

Currently, the main treatment methods for OVCF in clinical practice are non-surgical treatment and surgical treatment; non-surgical treatment primarily involves bed rest, analgesic medication, physical therapy and active anti-OP treatment to achieve fracture healing and pain relief.6 However, this treatment approach has a lengthy cycle, and prolonged bed rest can lead to further bone loss, increasing the risk of fractures in other areas such as the femoral neck; additionally, complications like bedsores, lung infections and lower extremity vascular embolism may arise.7 Lee et al found that the pain improvement rate of OVCF patients treated non-surgically was only 65%, indicating unsatisfactory therapeutic outcomes.8

Given the challenges presented by non-surgical treatment, minimally invasive vertebral augmentation, specifically percutaneous vertebroplasty (PVP) and PKP, has become the primary clinical treatments for OVCF; both surgical techniques offer advantages such as reduced trauma, faster recovery and high safety, making them widely used in clinical practice.9 However, compared with PKP, PVP is less effective in correcting kyphotic deformity and carries a relatively higher risk of bone cement leakage after surgery.10 Consequently, PKP gradually becomes the preferred choice for OVCF treatment.

Although the clinical efficacy of vertebral augmentation surgery for OVCF is well-documented, studies have indicated that approximately 1.8%–31.9% of patients treated with this procedure experience residual low back pain requiring clinical intervention.11 The extent and severity of residual low back pain after PKP in OVCF patients varies among individuals, which may result from multiple factors.12 Some researchers have suggested that the amount of bone cement injected, the timing of injection and the injury to the lower back muscles at the fracture site may contribute to residual low back pain after PKP.13 The complex pathogenic mechanism further complicates clinical treatment; residual low back pain after vertebral augmentation not only prolongs the postoperative recovery time but also increases the likelihood of related complications.14 It also reduces patient satisfaction and trust in the treatment.

Modern medicine aims to relieve pain and improve mobility, function and quality of life in interventions for residual low back pain after PKP in OVCF patients, so non-surgical first-line treatment options, including anti-inflammatory drugs, physical therapy, education and epidural steroid injections, are recommended.15 However, the efficacy of pain relief varies, and these drugs carry varying degrees of side effects. Therefore, combining other complementary and alternative therapies with the treatment of OVCF combined with PKP residual low back pain is necessary to achieve better therapeutic outcomes.16

Description of the intervention

Historically, acupuncture has been widely recognised and used as a complementary and alternative therapy, which has shown significant clinical results in the treatment of a variety of conditions, including but not limited to chronic pain syndrome (Vickers et al),17 postoperative pain (Sun et al),18 migraines (Linde et al),19 osteoarthritis (Corbett et al)20 and nausea/vomiting associated with chemotherapy (Ezzo et al).21 Acupuncture relieves pain, tension and stress by inserting fine needles into the skin to stimulate nerves, muscles and connective tissues throughout the body with very rare serious side effects (Patil et al).22

Since 1980, WHO has recommended acupuncture as an alternative therapy for 43 different diseases.23 Studies have shown that approximately 8 million Americans have received acupuncture treatment for chronic pain such as arthritis, lower back pain and migraines; consequently, acupuncture is often used as a complementary therapy alongside conventional medication for pain in the United States.24

How the intervention might work?

According to traditional Chinese medicine, pain arises from the disharmony of Zang-fu, meridians, Qi and blood circulation, resulting in disrupted functioning. Acupuncture treatment aims to restore balance in Zang-fu organs by stimulating and warming acupuncture points, thereby unblocking and promoting the flow of Qi and blood. This helps improve the condition of diseased areas, restore the balance of Qi, blood and Yin and Yang and alleviate pain.

Modern research suggests that apart from the pain centre in the central nervous system, there exists a ‘pain modulation system’ at all levels of the central system that can inhibit pain transmission to the centre.25 After acupuncture signals enter the central system, they activate numerous neurons at different levels ranging from the spinal cord and brainstem to the brain.26 This activation stimulates the body’s analgesic system, leading to increased secretion of analgesic substances like 5-hydroxytryptamine and acetylcholine.27 Acupuncture activates endogenous opioid mechanisms, enhances endogenous opiates such as enkephalins, dynorphins and endorphins, and releases corticosteroids to enhance the healing process (Kaptchuk),28 ultimately producing noticeable analgesic effects.

This post was originally published on https://bmjopen.bmj.com