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

NCT07246369 | Completed DMC

• 1 other identifier: REC-UOL-/493/08/24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain (CLBP); Post Cesarean Section Patient

Keywords

Low back pain; Post cesarean section; Post partum back pain

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  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)

  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

Study Arms (2)

Group A (Electrical Dry Needling)

EXPERIMENTAL

Other: Electrical Dry Needling

Group B (Therapeutic Ultrasound)

ACTIVE COMPARATOR

Other: Ultrasound

Interventions

Electrical Dry Needling OTHER

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)

Group A (Electrical Dry Needling)

Ultrasound OTHER

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

Group B (Therapeutic Ultrasound)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• Al-Husban N, Elmuhtaseb MS, Al-Husban H, Nabhan M, Abuhalaweh H, Alkhatib YM, Yousef M, Aloran B, Elyyan Y, Alghazo A. Anesthesia for Cesarean Section: Retrospective Comparative Study. Int J Womens Health. 2021 Feb 2;13:141-152. doi: 10.2147/IJWH.S292434. eCollection 2021.

  PMID: 33564269 BACKGROUND

• Al-Boloushi Z, Gomez-Trullen EM, Arian M, Fernandez D, Herrero P, Bellosta-Lopez P. Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial. BMJ Open. 2020 Aug 20;10(8):e038033. doi: 10.1136/bmjopen-2020-038033.

  PMID: 32819949 BACKGROUND

• A Abdel Hady D, Abd El-Hafeez T. Utilizing machine learning to analyze trunk movement patterns in women with postpartum low back pain. Sci Rep. 2024 Aug 12;14(1):18726. doi: 10.1038/s41598-024-68798-6.

  PMID: 39134567 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

High-Energy Shock Waves

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: November 24, 2025
• Study Start: October 14, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 10, 2025
• Last Updated: November 24, 2025

Record last verified: 2024-09

Locations

PA (1)