Pelvic PainNCT05537207
Laser at Lumbar Acupoint on Pain and Quality of Life in Chronic Pelvic Pain
A study testing low level laser therapy and non-steroidal drugs in people with Pelvic Pain, run by October 6 University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- low level laser therapy and non-steroidal drugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser at Lumbar Sensitized Acupoint on Pain Perception and Quality of Life in Female Chronic Pelvic Pain
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.
Read the 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
- Being tested
- low level laser therapy, non-steroidal drugs
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyDevice
Also called LLLT
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 drugsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | low level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory drugs Receives: 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. Receives: Other: non-steroidal drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Oct 2022
- Primary completion15 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537207
- Sponsor's protocol ID
- P.T. REC/012/003799
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40005470
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser at Lumbar Sensitized Acupoint on Pain Perception and Quality of Life in Female Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05537207
- Acronym / sponsor ID
- P.T. REC/012/003799
- Conditions
- Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: low level laser therapy, Other: non-steroidal drugslow level laser therapy (LLLT) on the acupuncture points.in addition to non-steroidal anti-inflammatory drugs |
| control group | Experimental | Other: non-steroidal drugsAll 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Thirty six female with chronic pelvic pain
- gonorrhoeae or C. trachomatis
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low level laser therapyAlso: LLLTlow 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 | Device | study group |
| non-steroidal drugsAll 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. | Other | control group, study group |
Primary outcome
visual analogue scale
Time frame: 4 weeks
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Pressure Algometer
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 40005470Hasanin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser therapy and non-steroidal drugs in people with Pelvic Pain, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05537207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.