Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome
Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome: A Randomized Controlled Trial
Obstructive defecation syndrome (ODS) is a condition in which a person has difficulty completely emptying the rectum during bowel movements. Women with ODS may experience excessive straining, a feeling of incomplete evacuation or blockage, abdominal discomfort, and the need to use manual assistance, laxatives, or enemas to facilitate defecation.
This randomized controlled trial will investigate the effect of adding low-level laser therapy (LLLT) to a conventional treatment program for women with ODS. Participants will be randomly assigned to one of two groups. The control group will receive nutritional modification and biofeedback training, while the study group will receive the same treatment in addition to low-level laser therapy applied to the lumbosacral region.
The study will evaluate whether adding low-level laser therapy can improve anorectal function, reduce the severity of ODS symptoms, and improve health-related quality of life compared with conventional treatment alone.
研究概览
地位
条件
详细说明
This study is a prospective, randomized, pre-posttest controlled trial designed to investigate the effect of low-level laser therapy (LLLT) as an adjunct to conventional treatment in women with obstructive defecation syndrome (ODS).
Women diagnosed with ODS will be randomly assigned to two groups. Participants in the control group will receive nutritional modification and biofeedback training. Nutritional modification will focus on dietary fiber intake, adequate hydration, and weight-management recommendations. Biofeedback training will provide real-time feedback to facilitate appropriate pelvic floor muscle control, relaxation, and coordination during defecation.
Participants in the study group will receive the same nutritional modification and biofeedback program in addition to low-level laser therapy. LLLT will be applied to the lumbosacral region, targeting the lumbar (L2-L5) and sacral (S1-S5) areas.
Participants will be assessed before and after the intervention. Anorectal manometry will be used to evaluate anorectal physiological parameters, including anal resting pressure, squeeze pressure, strain pressure, endurance, rectal sensitivity, and rectal compliance. The severity of obstructive defecation symptoms will be evaluated using the Renzi Obstructive Defecation Syndrome Score, and health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
The study aims to determine whether adding low-level laser therapy to nutritional modification and biofeedback training provides additional benefits in anorectal function, ODS symptom severity, and quality of life compared with nutritional modification and biofeedback training alone.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Doaa A. Osman, PhD
- 电话号码：01115792245
- 邮箱：Doaa.osman@cu.edu.eg
研究联系人备份
- 姓名：Radwa Ayad Mohamed, M.Sc
学习地点
-
-
-
Giza、埃及
- Faculty of Physical Therapy, Cairo University
-
接触：
- Doaa A. Osman, PhD
- 电话号码：01115792245
- 邮箱：Doaa.osman@cu.edu.eg
-
接触：
- Radwa Ayad Mohamed, M.Sc
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Woman diagnosed with ODS according to the Renzi ODS score (≥ 9).
- They suffer from difficult defecation for at least three months.
- Their ages will range from 30-45 years old.
- Their body mass index (BMI) will range from 25-30 kg/m2.
- Their parity number will be 2-3 times.
Exclusion Criteria:
- Any abnormalities around cancer colon, interstitial cystitis, or endometriosis.
- Enlarged rectal diameter and damaged mienteric plexus and abnormal motor function of rectum.
- Psychological or mental health problems.
- Pregnancy and lactation
- A history of previous pelvic surgery.
- A history of retinopathy.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Nutritional modification + Biofeedback muscle training
It will consist of 20 women with Obstructive Defecation Syndrome.
They will be treated by nutritional modification and biofeedback muscle training, twice weekly for 8 weeks.
|
Participants will receive nutritional modification throughout the intervention period.
The program will include a fiber-rich diet containing both soluble and insoluble fiber to improve stool consistency and facilitate bowel movements.
Participants will also be instructed to maintain adequate hydration by consuming approximately 6-8 glasses of water per day.
The nutritional modification program will be applied to participants in both the control and study groups.
Participants will receive anorectal biofeedback training using a rectal biofeedback device that provides real-time visual or auditory feedback on pelvic floor muscle activity.
During each session, participants will be trained to improve pelvic floor muscle coordination and relaxation during simulated defecation.
They will be instructed to consciously relax and release the pelvic floor muscles, use deep abdominal breathing, and practice relaxation techniques while observing the biofeedback signals.
Exercises will be repeated approximately 10-20 times per session according to participant tolerance and therapist assessment.
The intervention will be administered twice weekly.
|
|
实验性的：Low level laser therapy + Nutritional modification + Biofeedback muscle training
It will consist of 20 women with Obstructive Defecation Syndrome.
They will be treated by the same nutritional modification and biofeedback muscle training, in addition to low level laser therapy, twice weekly for 8 weeks.
|
Participants will receive nutritional modification throughout the intervention period.
The program will include a fiber-rich diet containing both soluble and insoluble fiber to improve stool consistency and facilitate bowel movements.
Participants will also be instructed to maintain adequate hydration by consuming approximately 6-8 glasses of water per day.
The nutritional modification program will be applied to participants in both the control and study groups.
Participants will receive anorectal biofeedback training using a rectal biofeedback device that provides real-time visual or auditory feedback on pelvic floor muscle activity.
During each session, participants will be trained to improve pelvic floor muscle coordination and relaxation during simulated defecation.
They will be instructed to consciously relax and release the pelvic floor muscles, use deep abdominal breathing, and practice relaxation techniques while observing the biofeedback signals.
Exercises will be repeated approximately 10-20 times per session according to participant tolerance and therapist assessment.
The intervention will be administered twice weekly.
Participants in the study group will receive low-level laser therapy (LLLT) using a Scanner Laser PR 999 4W device with dual wavelengths (continuous 808 nm and pulsed 940 nm).
LLLT will be applied to the lumbosacral region, targeting the lumbar (L2-L5) and sacral (S1-S5) areas.
Participants will be positioned prone, and the laser scanner will be applied perpendicular to the skin at a 90° angle, approximately 1-2 inches above the treatment area.
The scanner will be moved slowly to provide uniform coverage of the lumbosacral region.
Each treatment session will last 30 minutes and will be administered twice weekly for 8 weeks.
Both participants and therapists will wear appropriate protective eyewear during treatment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score
大体时间：8 weeks
|
The severity of obstructive defecation syndrome (ODS) will be assessed using the Renzi ODS Score.
The scale consists of five items assessing excessive straining, incomplete rectal evacuation, use of enemas and/or laxatives, vaginal-anal-perineal digitations, and abdominal discomfort and/or pain.
The total score ranges from 0 to 20, with higher scores indicating greater severity of ODS symptoms.
A score of ≥9 is used to identify ODS.
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anal Resting Pressure Assessed by Anorectal Manometry
大体时间：8 weeks
|
Anal resting pressure will be assessed using anorectal manometry.
After insertion of the anorectal manometry probe, the participant will be allowed to relax for approximately 3-5 minutes to allow anal sphincter tone to return to baseline.
Basal anal pressure will then be recorded at rest over 60 seconds.
The outcome will be expressed in mmHg.
|
8 weeks
|
|
Anal Squeeze Pressure Assessed by Anorectal Manometry
大体时间：8 weeks
|
Anal squeeze pressure will be assessed using anorectal manometry during voluntary contraction of the anal sphincter and pelvic floor muscles.
Participants will perform three maximum voluntary squeezes, each maintained for approximately 5 seconds, with a 30-second recovery period between attempts.
The average pressure obtained from the three attempts will be used for analysis and expressed in mmHg.
|
8 weeks
|
|
Anal Strain Pressure Assessed by Anorectal Manometry
大体时间：8 weeks
|
Anal strain pressure will be assessed using anorectal manometry during simulated defecation.
Participants will be instructed to perform a bearing-down maneuver to simulate defecation.
Three straining attempts will be performed, with each attempt lasting approximately 15 seconds and separated by a 30-second recovery interval.
The average pressure obtained from the three attempts will be used for analysis and expressed in mmHg.
|
8 weeks
|
|
Anal Sphincter Endurance Assessed by Anorectal Manometry
大体时间：8 weeks
|
Anal sphincter endurance will be assessed using anorectal manometry during a sustained maximum voluntary contraction.
Endurance will be defined as the length of time for which the participant can maintain pressure during the maximum voluntary contraction.
The outcome will be recorded in seconds, with a longer duration indicating greater ability to sustain the contraction.
|
8 weeks
|
|
Rectal Sensitivity Assessed by Anorectal Manometry
大体时间：8 weeks
|
Rectal sensitivity will be assessed using graded balloon distension during anorectal manometry.
Participants will be instructed to report the first rectal sensation, desire or urgency to defecate, and maximum tolerated sensation during progressive balloon inflation.
The corresponding balloon volumes will be recorded in milliliters (mL).
Lower sensory threshold volumes indicate greater rectal sensitivity, whereas higher threshold volumes indicate reduced rectal sensitivity.
|
8 weeks
|
|
Rectal Compliance Assessed by Anorectal Manometry
大体时间：8 weeks
|
Rectal compliance will be assessed during anorectal manometry using controlled rectal balloon distension.
Compliance will be determined from the relationship between changes in balloon volume and corresponding changes in steady-state intrarectal pressure (ΔV/ΔP).
Higher values indicate greater rectal distensibility, whereas lower values indicate greater resistance to rectal distension.
|
8 weeks
|
|
Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
大体时间：8 weeks
|
Health-related quality of life will be assessed using the 36-item Short Form Health Survey (SF-36).
The questionnaire evaluates eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Each domain is scored from 0 to 100, with higher scores indicating a more favorable health status.
|
8 weeks
|
合作者和调查者
调查人员
- 学习椅：Mohamed Ahmed Mohamed Awad, PhD、Professor, Cairo University
- 研究主任：Doaa A. Osman, PhD、Ass. Professor, Cairo University
- 研究主任：Hesham Mahmoud Salah El-Din, PhD、Professor, Cairo University
- 首席研究员：Radwa Ayad Mohamed, M. Sc、PhD Student, Cairo University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.