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

NCT05537207 | Completed

• 1 other identifier: P.T. REC/012/003799
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (3)

• 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).

  4 weeks

• 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

  4 weeks

• 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

  4 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

control group

EXPERIMENTAL

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

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

Also known as: LLLT

study group

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.

control group; study group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40005470 DERIVED

MeSH Terms

Conditions

Pelvic Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: October 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 30, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

EG (1)