The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain

Official title

The Effect of Extracorporeal Shock Wave Therapy (ESWT) Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain: A Randomized Controlled Trial

Overview

Chronic low back pain (CLBP) is a major public health concern worldwide, leading to reduced quality of life and significant work loss. It is defined as pain lasting more than 12 weeks between the lumbar and sacral spinal segments. The global prevalence of CLBP ranges from 13.1% to 20.3%, and the number of affected individuals has increased from 370 million in 1990 to 570 million in 2017. Core muscles, including the multifidus, erector spinae, transversus abdominis, psoas major, and quadratus lumborum, play a key role in spinal stabilization. In patients with CLBP, dysfunction and loss of synergy among these muscles can compromise spinal balance. Prolonged poor posture can reduce the strength and endurance of the lumbar erector spinae, multifidus, and transversus abdominis, leading patients to compensate by overusing the erector spinae, rectus abdominis, and oblique abdominal muscles. This compensation is considered one of the primary contributors to chronic low back pain. These deep core muscles can be objectively evaluated using ultrasonography (USG), a non-invasive, inexpensive, and accessible imaging method. Strain elastography, a quantitative ultrasonographic technique, is increasingly used to assess tissue stiffness and monitor structural changes in muscle over time. Conventional treatments for CLBP include pharmacotherapy, exercise, and physical therapy. In recent years, extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive, easily applicable, and low-risk treatment method. ESWT is widely used in various musculoskeletal conditions such as lateral epicondylitis, patellar tendinopathy, and calcific tendinitis of the shoulder. Studies have shown that ESWT provides pain relief and functional improvement in patients with CLBP through its angiogenic, anti-inflammatory, analgesic, and tissue-regenerative effects. Several studies have demonstrated the positive impact of ESWT on pain reduction and functional recovery in CLBP. A recent meta-analysis reported that ESWT significantly reduces pain in CLBP patients and may be superior to other conservative treatments. Yue et al. (2021) highlighted the short-term benefits of ESWT in reducing pain and disability, while also emphasizing the need for well-designed randomized controlled trials (RCTs) to establish high-quality evidence. Similarly, Wu et al. (2023) underscored the necessity of including objective outcomes in future RCTs to better evaluate the efficacy of ESWT. Although numerous studies have assessed the effects of ESWT on pain, disability, and functional outcomes in CLBP, to date, no study has objectively evaluated its effectiveness using ultrasonographic strain elastography focusing on the elasticity and stiffness of core muscles. This study aims to be one of the first to assess the long-term effects of ESWT using objective measures. Its contribution to the literature lies in evaluating the efficacy of ESWT, when added to conventional physical therapy, through long-term monitoring with ultrasonographic strain elastography in patients with CLBP.

Interventions

• Device Radial Extracorporeal Shock Wave Therapy
  A total of 6 sessions of ESWT, applied twice a week. Each ESWT session will last approximately 15 minutes. ESWT will be administered with the patient in the prone position, using an energy density of 0.15 mJ/mm², at 4 Hz frequency, and 1,500 shock waves per session. The ESWT application will be performed on the right and left paravertebral muscles between the L3 and S1 segments.
• Other Conventional rehabilitation
  A total of 15 sessions of conventional physical therapy will be administered, five times per week. Each session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment will be applied over a total period of 3 weeks.

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: Baseline, 3rd week, 12th week]

Secondary outcome measures (2)

• Oswestry Disability Index (ODI) [Time frame: Baseline, 3rd week, 12th week]
• Sonoelastography -Strain Index: [Time frame: Baseline, 3rd week ,12th week]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years
• Non-specific low back pain lasting more than three months

Exclusion criteria

• Specific lumbar spine diseases (radicular pain, spinal stenosis, infection)
• History of trauma, fracture, surgery, or presence of scar tissue in the lumbar region
• Presence of a disease that may affect muscle stiffness, such as collagen tissue disorders, hemiplegia, multiple sclerosis, or myopathies
• Malignancy, pregnancy, severe hypertension
• Coagulopathy, chronic heart disease
• Ankylosing spondylitis
• Diseases that may initially affect lumbar mobility and pain, such as leg length discrepancy, hip prosthesis, or scoliosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University — Denizli

Identifiers

NCT: NCT07132762 · PamukkaleU.ftr-FArdıç-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗