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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-04-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Low Back Pain (CLBP) Post Cesarean Section Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A (Electrical Dry Needling)

Group Type EXPERIMENTAL

Electrical Dry Needling

Intervention Type 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 B (Therapeutic Ultrasound)

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type 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

Interventions

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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)

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No