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Completed

NCT Number: NCT05537207

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

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.

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Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lama S Mahmoud

Al Jīzah, Select State, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Low Level Laser Therapy

Device

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

Other names: LLLT

non-steroidal drugs

Other

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.

Primary outcomes

  1. visual analogue scale

    Time frame: 4 weeks

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

  2. Pressure Algometer

    Time frame: 4 weeks

    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

  3. Short-Form Health Survey

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Effect of Laser at Lumbar Sensitized Acupoint on Pain Perception and Quality of Life in Female Chronic Pelvic Pain

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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