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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537207
• Other study ID #: P.T. REC/012/003799
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Device:
• 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

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Lama S Mahmoud	Al Jizah	Select State

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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