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

NCT ID: NCT05537207

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-01-30

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.

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

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

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

Group Type: EXPERIMENTAL

low level laser therapy

Intervention Type: 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

non-steroidal drugs

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

non-steroidal drugs

Intervention Type: 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.

Interventions

low 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

Intervention Type: DEVICE

non-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.

Intervention Type: OTHER

Other Intervention Names

LLLT

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40005470 (View on PubMed)

Other Identifiers

P.T. REC/012/003799

Identifier Type: -

Identifier Source: org_study_id