The Role of Therapeutic Ultrasound in Comparison With Electrical Dry Needling in Chronic Low Back Patients Post Cesarean Section

November 17, 2025 updated by: University of Lahore

HYPOTHESIS

Null Hypothesis (HO):

There was a non-significant difference in the role of therapeutic ultrasound in comparison with electrical dry needling in chronic low back patients post cesarean-section.

Alternative Hypothesis (HA):

There was a significant difference in the role of therapeutic ultrasound in comparison with electrical dry needling in chronic low back patients post cesarean-section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 25-35 years.
  • History of cesarean section with epidural anesthesia
  • Within the past 6 months to 8 months.
  • Primiparous, postpartum women.
  • Chronic low back pain persisting for more than 3 months.
  • Pain intensity of at least four on a Numeric Pain Rating Scale (NPRS).

Exclusion Criteria:

  • Previous low back surgery.
  • Multiparous, postpartum women.
  • History of Fracture (pubic fractures, vertebral fracture) and osteoporosis
  • Having a stillborn fetus or lethal induction of labor.
  • Severe comorbid conditions (e.g., uncontrolled diabetes, cardiovascular disease).
  • Patients who experienced a C-section with general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Electrical Dry Needling)
Other: Electrical Dry Needling
Patients in the electrical dry-needling received two 30-minute sessions per week for 6 weeks. Twenty minutes of Electrical stimulation targeted active and latent myofascial trigger points in the quadratus lumborum, multifidus, and iliocostalis muscles following MTrP. Needle insertion sites were varied based on the therapist's assessment of MTrP activity. Needles (0.25 mm × 30 mm or 0.30 mm × 40 mm) were sterilized and inserted into the trigger points, reaching the taut bands and causing local twitch responses. Needles were connected to a TENS device generating a low-frequency current (2 Hz) with a pulse duration of 250 μs and a continuous biphasic waveform, set to a "mild to moderate" intensity as reported by the patient. The 10 minutes of stretching of the quadratus lumborum, multifidus, and iliocostal muscles, including seated side stretches, cat-cow, and child's pose, improve muscle flexibility and reduce tension. (Lara-Palomo et al., 2022)
Active Comparator: Group B (Therapeutic Ultrasound)
Other: Ultrasound
In this study, participants received 12 sessions over 6 weeks, each lasting 30 minutes. The therapeutic ultrasound group received 20 minutes of continuous ultrasound using the Enraf Nonius Sonoplus 434 at 1 MHz frequency and 1.5 W/cm² intensity, applied with slow circular movements over the lower back. Treatment duration was calculated based on the area of pain using Grey's formula. Both groups also participated in a semi-supervised exercise program, starting with 10 minutes of stretching exercises for the lower back and abdominal muscles (quadratus lumborum, multifidus, and iliocostal muscles including seated side stretch, cat-cow, and child's pose improve muscle flexibility and reduce tension.) as guided by the physiotherapist. Patients were encouraged to stay active daily, perform exercises correctly, and avoid other pain treatments during the study. After completing the treatment sessions, patients continued the exercise for progress assessment until the follow-up session. (Gocevsk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline to 6 Week
Participants in the study expressed the severity of their pain using a 10 Numeric Pain Rating Scale (NPRS). Participants are instructed to locate their level of pain on a 10-mm horizontal line, with 0 mm representing "no pain" and 10 mm representing "the most severe pain."
Baseline to 6 Week
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 6 Week
It is a measurement tool used to assess individuals' fear of movement and re-injury. This 17-item questionnaire is designed to determine an individual's fear of movement and the possibility of (re)injury. Patients evaluate their beliefs on their kinesiophobia using a 4-point scale that spans from strongly disagree to strongly agree.
Baseline to 6 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

August 26, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-UOL-/493/08/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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