Chronic Low Back Pain (CLBP)NCT07246369
The Role of Therapeutic Ultrasound in Comparison With Electrical Dry Needling in Chronic Low Back Patients Post Cesarean Section
A study testing Electrical Dry Needling and Ultrasound in people with Chronic Low Back Pain (CLBP) and Post Cesarean Section Patient, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Post Cesarean Section Patient
- What is being tested?
- Electrical Dry Needling and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Electrical Dry Needling, Ultrasound
- Keywords
- Low back pain, Post cesarean section, Post partum back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Dry NeedlingOther
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)
UltrasoundOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (Electrical Dry Needling) | Experimental | Not described Receives: Other: Electrical Dry Needling |
| Group B (Therapeutic Ultrasound) | Active comparator | Not described Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: Baseline to 6 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start14 Oct 2024
- Primary completion30 Mar 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246369
- Sponsor's protocol ID
- REC-UOL-/493/08/24
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33564269Al-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.
PubMed 32819949A 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.
PubMed 39134567
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Therapeutic Ultrasound in Comparison With Electrical Dry Needling in Chronic Low Back Patients Post Cesarean Section
- ClinicalTrials.gov ID
- NCT07246369
- Acronym / sponsor ID
- REC-UOL-/493/08/24
- Keywords
- Low back pain, Post cesarean section, Post partum back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Electrical Dry Needling) | Experimental | Other: Electrical Dry Needling |
| Group B (Therapeutic Ultrasound) | Active comparator | Other: Ultrasound |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Dry NeedlingPatients 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) | Other | Group A (Electrical Dry Needling) |
| UltrasoundIn 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 | Other | Group B (Therapeutic Ultrasound) |
Primary outcome
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."
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 33564269Al-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.
- Background: PubMed 32819949Al-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.
- Background: PubMed 39134567A 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Dry Needling and Ultrasound in people with Chronic Low Back Pain (CLBP) and Post Cesarean Section Patient, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline to 6 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.