Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain: A Randomized Single-Blinded Multicenter Clinical Trial

Mohammad Ali6 个研究点分布在 1 个国家目标入组 208 人开始时间: 2025年11月19日最近更新: 2025年11月8日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 208
试验地点: 6
主要终点: 1. Back pain intensity (0-10 numerical rating

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Title: Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain: A Randomized Single-Blinded Multicenter Clinical Trial

Summary: This is a proposed randomized, single-blinded, multicenter clinical trial designed to evaluate the effectiveness of Shortwave Diathermy (SWD) for chronic low back pain (CLBP). The study will enroll 140 adults with CLBP and randomly assign them to one of two groups: one receiving active SWD plus standard physiotherapy and the other receiving sham SWD plus standard physiotherapy.

The primary goal is to determine if active SWD is more effective than a sham procedure at reducing pain (measured on a Visual Analog Scale) and improving functional outcomes over a 4-week intervention period with a 3-month follow-up. The study aims to provide high-quality evidence to either support the integration of SWD into CLBP treatment guidelines or to discourage its use if it proves ineffective.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•A primary complaint of either: a.
•low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s) or b.
•referred leg pain without back pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, presumed to be of lumbar spine origin.
•Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)
•Aged between 18 and 65 (inclusive)
•Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and any exercises already being undertaken.

排除标准

•Active cancer under current treatment, as the treatment of cancer may interfere with their ability to participate in the trial
•Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
•Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation
•Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
•Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs
•A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low severity
•Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for one hour or more and no sleep disturbance at night, as we wish to exclude people with low severity
•Already received more than 5 sessions of physiotherapy with any of the treating physiotherapists before enrolment, as this could influence treatment expectations in patients
•Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants
•Planned absence of more than one week during the treatment period (such as extended holidays).