Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain

NCT06959394 | Completed

• 1 other identifier: KaratayMST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of therapeutic ultrasound and phonophoresis applications on pain, range of motion, flexibility and functional capacity in patients with chronic low back pain. The study is planned as the first scientific study comparing the effectiveness of these two physiotherapy methods in the treatment of chronic low back pain. It is aimed to make national and international publications with the data obtained at the end of the study. The study will be conducted in a randomised single-blind, placebo-controlled design. 60 patients aged 18-30 years with chronic low back pain will be divided into 3 groups: therapeutic ultrasound (US) application, phonophoresis application and placebo US group. In addition to ultrasound and phonophoresis, TENS, infrared and low back exercises will be applied to all groups as treatment. Pain intensity (VAS), functional status (Oswestry disability index), flexibility (Sit-to-Sit test) and range of motion (goniometric measurements) will be assessed throughout the treatment period. The study aims to make an important contribution from a clinical and economic point of view, given the increasing prevalence of low back pain worldwide and the need for treatment. The findings may guide the development of future treatment modalities.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• pain severity

  Visual Analog Scale

  Baseline and after 2 weeks intervation

Secondary Outcomes (3)

• functional state

  Baseline and after 2 weeks intervation

• Flexibility

  Baseline and after 2 weeks intervation

• range of motion of the joint

  Baseline and after 2 weeks intervation

Study Arms (3)

US

EXPERIMENTAL

Participants will be treated with 1.5 W/cm2, 6 min (transmitting agent aquasonic gel) ultrasound.

Other: Ultrasound

Phonophoresis

EXPERIMENTAL

Other: Phonophoresis

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Ultrasound OTHER

Participants will receive ultrasound at 1.5 W/cm2 for 6 minutes (transmitter agent aquasonic gel) 5 sessions per week for 2 weeks.

US

Phonophoresis OTHER

Participants will receive ultrasound with 1.5 W/cm2, 6 min (transmitter diclofenac gel) for 5 sessions per week for 2 weeks.

Phonophoresis

Placebo OTHER

Participants will receive 0 W/cm2, 6 min ultrasound, 5 sessions per week for 2 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals with low back pain for more than 3 months and pain intensity more than 5 according to VAS will be included in the study

You may not qualify if:

• patients who have undergone surgical operations

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Konya, 42100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

High-Energy Shock Waves; Phonophoresis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Drug Administration Routes; Drug Therapy; Therapeutics

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: principle invastigator

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2025-06

Locations

TU (1)