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

Study Overview
=================
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

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

Conditions
-----------------
Pelvic Pain

Intervention / Treatment
-----------------
* Device: low level laser therapy
* Other: non-steroidal drugs


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>low level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory drugs | Device: low level laser therapy<br>* 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<br>* Other names: LLLT;Other: non-steroidal drugs<br>* 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.<br>|
| Experimental: control group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |