Laser at Lumbar Acupoint on Pain and Quality of Life in Chronic Pelvic Pain
Primary Purpose
Pelvic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy
non-steroidal drugs
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain
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
Sites / Locations
- Lama S MahmoudRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
low level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory 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 will be described by their gynecologist.
Outcomes
Primary Outcome Measures
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).
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05537207
First Posted
September 9, 2022
Last Updated
September 9, 2022
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT05537207
Brief Title
Laser at Lumbar Acupoint on Pain and Quality of Life in Chronic Pelvic Pain
Official Title
Effect of Laser at Lumbar Sensitized Acupoint on Pain Perception and Quality of Life in Female Chronic Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
low level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory drugs
Arm Title
control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
LLLT
Intervention Description
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
Other
Intervention Name(s)
non-steroidal drugs
Intervention Description
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 Outcome Measure Information:
Title
visual analogue scale
Description
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Time Frame
4 weeks
Title
Pressure Algometer
Description
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
Time Frame
4 weeks
Title
Short-Form Health Survey
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud
Phone
01157592636
Email
lamaelsedawyy@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Laser at Lumbar Acupoint on Pain and Quality of Life in Chronic Pelvic Pain
We'll reach out to this number within 24 hrs