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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Doaa A. Osman, PhD
- Número de telefone: 01115792245
- E-mail: Doaa.osman@cu.edu.eg
Estude backup de contato
- Nome: Radwa Ayad Mohamed, M.Sc
Locais de estudo
-
-
-
Giza, Egito
- Faculty of Physical Therapy, Cairo University
-
Contato:
- Doaa A. Osman, PhD
- Número de telefone: 01115792245
- E-mail: Doaa.osman@cu.edu.eg
-
Contato:
- Radwa Ayad Mohamed, M.Sc
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anal Resting Pressure Assessed by Anorectal Manometry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Mohamed Ahmed Mohamed Awad, PhD, Professor, Cairo University
- Diretor de estudo: Doaa A. Osman, PhD, Ass. Professor, Cairo University
- Diretor de estudo: Hesham Mahmoud Salah El-Din, PhD, Professor, Cairo University
- Investigador principal: Radwa Ayad Mohamed, M. Sc, PhD Student, Cairo University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/006002
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .