Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome
2026년 8월 13일 업데이트: Doaa A. Osman, Cairo University
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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Doaa A. Osman, PhD
- 전화번호: 01115792245
- 이메일: Doaa.osman@cu.edu.eg
연구 연락처 백업
- 이름: Radwa Ayad Mohamed, M.Sc
연구 장소
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Giza, 이집트
- Faculty of Physical Therapy, Cairo University
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연락하다:
- Doaa A. Osman, PhD
- 전화번호: 01115792245
- 이메일: Doaa.osman@cu.edu.eg
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연락하다:
- Radwa Ayad Mohamed, M.Sc
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score
기간: 8 weeks
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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.
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8 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anal Resting Pressure Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Anal Squeeze Pressure Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Anal Strain Pressure Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Anal Sphincter Endurance Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Rectal Sensitivity Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Rectal Compliance Assessed by Anorectal Manometry
기간: 8 weeks
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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.
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8 weeks
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Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
기간: 8 weeks
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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.
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8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 의자: Mohamed Ahmed Mohamed Awad, PhD, Professor, Cairo University
- 연구 책임자: Doaa A. Osman, PhD, Ass. Professor, Cairo University
- 연구 책임자: Hesham Mahmoud Salah El-Din, PhD, Professor, Cairo University
- 수석 연구원: Radwa Ayad Mohamed, M. Sc, PhD Student, Cairo University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 20일
기본 완료 (추정된)
기본 완료
2026년 12월 20일
연구 완료 (추정된)
연구 완료
2026년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- P.T.REC/012/006002
약물 및 장치 정보, 연구 문서
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .