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

NCT07132762 | Recruiting

• 1 other identifier: PamukkaleU.ftr-FArdıç-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain

Keywords

Extracorporeal Shockwave Therapy treatment (ESWT); Elastography; physical therapy; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS), a valid and reliable method for measuring pain intensity, will be used. VAS is a 10-centimeter-long horizontal line that allows patients to assess their pain or symptoms. The left end of the line (0 cm) typically represents "No Pain" or "Painless," while the right end (10 cm) indicates "Unbearable Pain" or "Worst Possible Pain." Participants will be asked to mark a point on the line that corresponds to their current level of pain or symptoms. The marked point is then measured and recorded as a score ranging from 0 to 10. The resulting VAS scores will be used to quantitatively assess the severity of participants' pain or symptoms.

  Baseline, 3rd week, 12th week

Secondary Outcomes (2)

• Oswestry Disability Index (ODI)

  Baseline, 3rd week, 12th week

• Sonoelastography -Strain Index:

  Baseline, 3rd week ,12th week

Study Arms (2)

ESWT + Conventional Physical Therapy Group

EXPERIMENTAL

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

Device: Radial Extracorporeal Shock Wave Therapy; Other: Conventional rehabilitation

Conventional Physical Therapy Group

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

Interventions

Radial Extracorporeal Shock Wave Therapy DEVICE

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.

ESWT + Conventional Physical Therapy Group

Conventional rehabilitation OTHER

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.

Conventional Physical Therapy Group; ESWT + Conventional Physical Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Study Officials

• Füsun Ardıç, Professor

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Füsun Ardıç, Professor

CONTACT

+905342197714; ardicf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

TU (1)