Constipation-predominant Irritable Bowel SyndromeNCT05757037
Laser Acupuncture on Irritable Bowel Syndrome in Females
A study testing laser acupuncture in people with Constipation-predominant Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Sep 2024
- 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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants will meet diagnostic criteria (Rome IV) for IBS-C
- Their age will range from 20-35 years old
- Their body mass index (BMI) will range from >18.5kg/m2 and <29.9kg/m2
Who cannot join
- Taking medications known to cause constipation
- Any organic diseases that might induce constipation such as colorectal cancer, metabolic disorders, multiple sclerosis, or neurological disorders
- Organic diseases of the small or large intestine such as ulcerative colitis and Crohn's disease
- A history of gastrointestinal surgery (other than appendectomy or cholecystectomy)
- Mechanical obstruction
- Serious concomitant disease of the heart, liver, or kidney or diabetes
Show all 9Show fewer
- Pregnant or lactating women
- Severe psychiatric disorders
- Knowledgeable of acupoints and meridians that might unblind the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Acupuncture for Treatment of Female Patients With Irritable Bowel Syndrome:RCT
The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients
Read the detailed description
Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder characterized by recurrent abdominal pain and/or bloating related to defecation without reliable biological markers . IBS is associated with substantial burden, such as higher levels of anxiety, lost productivity at work, work absenteeism (Pimentel, 2018). IBS has a strong predominance in women IBS-C includes a wide range of symptoms, and its pathophysiology is complex and not fully understood. Visceral hypersensitivity and delayed gut transit are recognized as major pathophysiological mechanisms in IBS-C. Visceral hypersensitivity may account for symptoms of abdominal pain, bloating, and discomfort. Delayed gut transit causes constipation The unsatisfactory treatment responses and adverse effects associated with pharmacologic therapies have resulted in a higher demand for alternative therapies Acupoints and manipulations are the same in both the experimental and the control groups. The participants in the control group will receive sham laser acupuncture treatment, without any laser output, while the participants in the experimental group will sequentially receive 0.375J of energy at each of the following acupoints: Baihui (GV20), Yintang (GV29), Taichong (LR3), Zusanli (ST36), Sanyinjiao (SP6), Tianshu (ST25), and Shangjuxu (ST37) acupoint .Using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz]. The laser treatment will be applied to each point for 5 seconds, to deliver a total treatment dose of 4.5J/cm2 . intervention will be 3t/ week for 6 weeks in both groups.
- Being tested
- laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz].
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture group | Experimental | The participants in this group will receive low level laser therapy 3 times weekly for 4 weeks. A diode laser emitter with a 650 nm wavelength, an average power of 30 mW, and a 0.15 cm2 spot size, with continuous wave, and exposure of 90 s per acupuncture point had been used in the current study at each of the following acupoints: : ST25, ST37 , LI11 , BL60 , and BL25 Also, participants will recieve received behavioral therapy advice: Sitting on the toilet for 10-15 min after breakfast and after dinner and maintaining the same bathroom schedule every day, sitting in the correct position on the toilet (leaning forward while resting forearms on thighs, raising both feet on a small block (like a step stool) with feet apart, relax and lower the shoulders, and do not suppress urges to defecate and relax stomach muscles). Dietary modifications include a high-fiber diet, fruits, vegetables, whole grain, dairy, and wheat Receives: Device: laser acupuncture |
| Sham laser acupuncture | Sham comparator | The participants in the control group will receive sham laser acupuncture treatment, without any laser output. The participants are unable to recognize whether they are being treated or not because laser acupuncture is a low-intensity and non-thermal laser irradiation.
Also, participants will receive behavioral therapy advice. Receives: Device: laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)
Measured: 6 weeks
Irritable Bowel Syndrome Severity Score (IBS-SSS)
Measured: 6 weeks
Secondary outcomes (2)
IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)
Measured: 6 weeks
Visceral Sensitivity Index (VSI)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757037
- Sponsor's protocol ID
- P.T/WH/2/2023/31
- Status last verified
- Jan 2024
- First submitted
- 24 Feb 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture for Treatment of Female Patients With Irritable Bowel Syndrome:RCT
- ClinicalTrials.gov ID
- NCT05757037
- Acronym / sponsor ID
- P.T/WH/2/2023/31
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients
Detailed description
Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder characterized by recurrent abdominal pain and/or bloating related to defecation without reliable biological markers . IBS is associated with substantial burden, such as higher levels of anxiety, lost productivity at work, work absenteeism (Pimentel, 2018). IBS has a strong predominance in women IBS-C includes a wide range of symptoms, and its pathophysiology is complex and not fully understood. Visceral hypersensitivity and delayed gut transit are recognized as major pathophysiological mechanisms in IBS-C. Visceral hypersensitivity may account for symptoms of abdominal pain, bloating, and discomfort. Delayed gut transit causes constipation The unsatisfactory treatment responses and adverse effects associated with pharmacologic therapies have resulted in a higher demand for alternative therapies Acupoints and manipulations are the same in both the experimental and the control groups. The participants in the control group will receive sham laser acupuncture treatment, without any laser output, while the participants in the experimental group will sequentially receive 0.375J of energy at each of the following acupoints: Baihui (GV20), Yintang (GV29), Taichong (LR3), Zusanli (ST36), Sanyinjiao (SP6), Tianshu (ST25), and Shangjuxu (ST37) acupoint .Using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz]. The laser treatment will be applied to each point for 5 seconds, to deliver a total treatment dose of 4.5J/cm2 . intervention will be 3t/ week for 6 weeks in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture group | Experimental | Device: laser acupunctureThe participants in this group will receive low level laser therapy 3 times weekly for 4 weeks. A diode laser emitter with a 650 nm wavelength, an average power of 30 mW, and a 0.15 cm2 spot size, with continuous wave, and exposure of 90 s per acupuncture point had been used in the current study at each of the following acupoints: : ST25, ST37 , LI11 , BL60 , and BL25 Also, participants will recieve received behavioral therapy advice: Sitting on the toilet for 10-15 min after breakfast and after dinner and maintaining the same bathroom schedule every day, sitting in the correct position on the toilet (leaning forward while resting forearms on thighs, raising both feet on a small block (like a step stool) with feet apart, relax and lower the shoulders, and do not suppress urges to defecate and relax stomach muscles). Dietary modifications include a high-fiber diet, fruits, vegetables, whole grain, dairy, and wheat |
| Sham laser acupuncture | Sham comparator | Device: laser acupunctureThe participants in the control group will receive sham laser acupuncture treatment, without any laser output. The participants are unable to recognize whether they are being treated or not because laser acupuncture is a low-intensity and non-thermal laser irradiation. Also, participants will receive behavioral therapy advice. |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All participants will meet diagnostic criteria (Rome IV) for IBS-C
- Their age will range from 20-35 years old
- Their body mass index (BMI) will range from >18.5kg/m2 and <29.9kg/m2
Key exclusion criteria (9 listed)
- Taking medications known to cause constipation
- Any organic diseases that might induce constipation such as colorectal cancer, metabolic disorders, multiple sclerosis, or neurological disorders
- Organic diseases of the small or large intestine such as ulcerative colitis and Crohn's disease
- A history of gastrointestinal surgery (other than appendectomy or cholecystectomy)
- Mechanical obstruction
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 |
|---|---|---|
| laser acupuncturea gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz]. | Device | Laser acupuncture group, Sham laser acupuncture |
Primary outcome
The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)
Time frame: 6 weeks
Irritable Bowel Syndrome Severity Score (IBS-SSS)
Time frame: 6 weeks
2 secondary outcomes
IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)
Time frame: 6 weeks
Visceral Sensitivity Index (VSI)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Related trials for Constipation-predominant Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome
Not yet recruitingPhase 4
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Constipation-predominant Irritable Bowel Syndrome, run by Cairo 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 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara Magdy Ahmed, lecturer (01063998331, saramagdy87@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2024.