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CompletedNCT05537207Updated Feb 11, 2025

Laser at Lumbar Acupoint on Pain and Quality of Life in Chronic Pelvic Pain

An interventional study of low level laser therapy and non-steroidal drugs in Pelvic Pain, sponsored by October 6 University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
Female
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Study summary

To investigate the effect of low-level laser at lumbar sensitized acupoint on pain perception in chronic pelvic pain. BACKGROUND: chronic pelvic pain is one of the serious problems in the female, resulting in pain and less physical activity.

Read the detailed description

Thirty six females with chronic pelvic pain will participate in this study. The patients will randomly be divided into two equal groups; the control group will receive non-steroidal anti-inflammatory drugs in the form of Brufen (Ibuprofen), 400 mg, 3 times per day after meals, for 6 weeks, as will described by their gynecologist. and the study group received the same treatment and low-level laser at lumbar sensitized Acupoint, three times per week for four weeks. The evaluation methods by visual analogue scale (VAS), pain sensitivity was evaluated by measuring mean values of pressure pain thresholds (PPT) using a Pressure Algometer, while the quality of life was evaluated by the 12-Item Short-Form Health Survey (SF-12) before and after the treatment

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Conditions studied

  • Pelvic Pain

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In context

Pelvic Pain

387 studies on the registry are indexed under Pelvic Pain; 84 are open to participants now.

This study's enrollment of 36 is below the median of 54 across 281 interventional studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

October 6 University is the lead sponsor of 142 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Thirty six female with chronic pelvic pain

    • Their age ranged from 25 to 40 years old.
    • With the maximum parity number three.
    • Their body mass index (BMI) (20:29.9) kg/m2.
    • their pain score on the Visual Analog Scale (VAS) above 4 cm
    • Thirty-six married women diagnosed with chronic pelvic pain (CPP)
    • with a prior history of treatment for pelvic inflammatory disease (PID)
    • women with periodic lower abdominal or pelvic pain for at least six months and met -- the clinical diagnostic criteria for PID based on the presence of all three major criteria: lower abdominal tenderness, cervical motion tenderness, and bilateral adnexal tenderness
    • at least one minor supporting criterion: oral temperature >38.3°C (101 °F), mucopurulent cervical discharge or cervical friability, abundant WBCs on saline microscopy of vaginal fluid, elevated ESR and/or CRP, or laboratory-confirmed cervical infection with N.

gonorrhoeae or C. trachomatis

Exclusion criteria

Exclusion Criteria:

  • Any difficulty to communicate or understanding program instructions
  • any other conditions that caused pain (for example fibromyalgia and arthritis)
  • any psychiatric or cognitive symptoms
  • any other musculoskeletal disorders or neurologic diseases
  • any other conditions causing pelvic pain (e.g., fibromyalgia, arthritis), history of musculoskeletal or neurological diseases affecting the lower extremities and spine (such as lumbar disc herniation), acute pelvic inflammatory disease (PID), pregnancy or lactation, tumors, pelvic congestion, tuberculous PID, endometriosis, adenomyosis, gynecological tumors, or other gyneco-logical conditions that could contribute to chronic pelvic pain (CPP).
  • any issues at acupoint sites (such as ulcers or skin conditions); impairments in other systems that could lead to pelvic and lumbosacral pain (e.g., digestive, motor, or urinary issues)
  • severe systemic illnesses affecting the hematologic, digestive, urinary, or cardiovascular systems
  • mental illness; cognitive deterioration
  • immune-compromising diseases (such as diabetes or HIV/AIDS); and contraindications to NSAIDs
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    study group

    low level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory drugs

    Device: low level laser therapy · Other: non-steroidal drugs

  • Experimental
    control group

    All women will receive non-steroidal anti-inflammatory drugs in the form of Brufen (Ibuprofen), 400 mg, 3 times per day after meals, for 6 weeks, as will be described by their gynecologist.

    Other: non-steroidal drugs

Interventions

  • Devicelow level laser therapy

    low level laser therapy (LLLT) on the acupuncture points. inadition to non-steroidal anti-inflammatory drugs.The parameters of the laser device are wave length of 904 nm, maximum average power of 5 milli Watts, a maximum repetition rate of 5 kHz, energy of up to 30 J/cm², and energy density of 2 J/cm2

    Also known as: LLLT

  • Othernon-steroidal drugs

    All women will receive non-steroidal anti-inflammatory drugs in the form of Brufen (Ibuprofen), 400 mg, 3 times per day after meals, for 6 weeks, as described by their gynecologist.

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What researchers measure

Primary outcomes

  1. visual analogue scale

    which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).

    Time frame: 4 weeks

  2. Pressure Algometer

    pain sensitivity was evaluated by measuring mean values of pressure pain thresholds (PPT) using a Pressure Algometer. it will be used to assess pain sensitivity through identifying the pressure pain threshold (PPT) for all women before and after treatment. It has a standardized 1.52 cm2 flat circular probe that is pushed against the subject until the pain threshold is reached

    Time frame: 4 weeks

  3. Short-Form Health Survey

    quality of life was evaluated by the 12-Item Short-Form Health Survey (SF-12) before and after the treatment. it is a 12-item questionnaire that was used to assess the quality of life of women in both groups

    Time frame: 4 weeks

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Study locations

1 site
  • Lama S Mahmoud
    Al Jīzah, Select State, Egypt
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References and documents

Publications

  • Hasanin ME, Aly SM, Taha MM, Mahmoud LSE, Aldhahi MI. The Effect of Laser Biostimulation at Sensitized Acupoints on Chronic Pelvic Pain and Quality of Life in Women with Pelvic Inflammatory Disease: A Randomized Controlled Trial. Medicina (Kaunas). 2025 Feb 18;61(2):354. doi: 10.3390/medicina61020354. PubMed 40005470 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05537207
Responsible party
Lama Saad El-Din Mahmoud (Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University) — Principal investigator
First posted
Sep 13, 2022
Start date
Oct 1, 2022
Primary completion
Dec 15, 2022
Completion
Jan 30, 2023
Last update
Feb 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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