Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial

Abstract

Background: Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN. Methods: A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-α and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN. Discussion: This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment.

Application of extracorporeal shock wave therapy in nervous system diseases: A review

“…Postherpetic neuralgia (PHN) is a common type of neuralgia related to neuronal damage and can seriously affect the quality of life due to the pain and poor response to the currently available treatments ( 76 , 77 ). The main approaches to PHN management are medication and invasive interventional therapies.…”

“…The main approaches to PHN management are medication and invasive interventional therapies. However, these methods have many adverse effects ( 76 ). Physicians have used non-invasive ESWT to treat the pain area of PHN.…”

“…It was found that both fESWT and rESWT could reduce pain ( 78 ) and produced effective outcomes with few side effects when PHN was treated by ESWT. For example, a clinical study has shown that when ESWT [rESWT: R15 probe (radius of 15 mm), 1–4 bar, 5,000–7,000 pulses, 10 Hz] was used to treat patients with PNH, ESWT reduced pain and improved life quality compared with conventional therapies ( 76 ). Another clinical study showed that the medium-energy ESWT with 6 sessions (fESWT, EFD of 0.09–0.16 mJ/mm 2 , frequency of 5 Hz, and 2,000 pulses) could reduce the numerical rating scale of PNH, suggesting that fESWT could alleviate the skin pain and itch ( 77 ).…”

Effect and safety of extracorporeal shockwave therapy for postherpetic neuralgia: A randomized single-blind clinical study

“…2019[814], date of approval: 30 December 2019) and registered at ChiCTR.org.cn (Identifier: ChiCTR1900025828, date of registration: 10 September 2019). The initial version of the protocol was published ( 17 ). Consolidated Standards of Reporting Trials (CONSORT) were followed.…”

Ju Re Ba Du therapy for Postherpetic neuralgia

“…The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN. [ 6 ] Neuropathic pain, such as postherpetic neuralgia, is a chronic disease like hypertension and diabetes, and requires long-term treatment to improve or control symptoms. [ 7 ]…”