ConstipationNCT06303011
Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.
A study testing Transcutaneous Electrical Nerve Stimulator and TENS on para sacral area with Abdominal Massage in people with Constipation, run by Riphah International University at 1 site in Pakistan.
Trial summary
Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Read more about this study
- Who is it for?
- Ages 14 to 35 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Transcutaneous Electrical Nerve Stimulator and TENS on para sacral area with Abdominal Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Mar 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 14 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 14 -35year
- Only females
- Laxatives at least once or more for 2weeks
- Non pregnant
- Chronic Constipation more then 6 months
Who cannot join
- Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions.
- Pregnant females suspected pregnant subjects, as well as those who were breast-feeding
- Non co-operative patients
- Female with underlying disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Abdominal Massage With TENS on Para Sacral Versus Sacral Area on Symptom Severity and Quality of Life in Severe Chronic Constipation Among Young Females
Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.
Read the detailed description
This study will be a Randomized Clinical trial and will be conducted at services Hospital in Lahore. The study will be completed with in the time duration of eight months. Purposive sampling technique will be used to collect the data. A sample size of Total 24 patients will be taken in this study. Patients will be divided into two groups.(Group A will be treated with TENS on sacral area and abdominal massage where as Group B will be treated with TENS on par sacral area and abdominal massage).PAC-SYM Questionaire,PAC-QOL Questionaire will be used to ask some questions related to patients 'symptoms and abdominal cramps or bloating.. All participants of the study will fill the PAC-SYMQ and PAC-QOL Q on day 1 as pre treatment values and at the end of 4th session as post treatment values respectively. The collected data will be analyzed on SPSS-25.
Keywords : constipation, Quality of life , abdominal massage.
- Conditions
- Constipation
- Being tested
- Transcutaneous Electrical Nerve Stimulator, TENS on para sacral area with Abdominal Massage
- Keywords
- Constipation, Quality of life, Abdominal massage
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulatorOther
TENS will be applied on sacral and parasacral area. Frequency 10Hz, Pulse duration 200μs, Stimulation duration 20min
TENS on para sacral area with Abdominal MassageOther
TENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200μs Stimulation duration 20min
| Study group | Role | What they receive |
|---|---|---|
| Group: A | Experimental | TENS on sacral areas with Abdominal Massage Receives: Other: Transcutaneous Electrical Nerve Stimulator |
| Group: B | Active comparator | TENS on para sacral area with Abdominal Massage Receives: Other: TENS on para sacral area with Abdominal Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC-SYM Questionnaire
It is a self-reported questionnaire consisting of 12 symptoms divided into three domains: abdominal, rectal and stool, with responses rated on a. 5-point.The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.
PAC-SYM Questionnaire Validity is 0.68 to 0.72 and reliability is 0.75to 0.89
Measured: 8 weeks
PAC-QOL Questionnaire
The following questions are designed to measure the impact constipation has had on your daily life over the past 2 weeks. The overall PAC-QOL score consisted of four domains: physical discomfort, psycho- social discomfort, satisfaction, and worries and concerns. A lower score indicated a better outcome for symptomatic relief and QOL. PAC-QOL Questionnaire Validity is 0.76 to 3.41 and reliability is >0.80.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303011
- Sponsor's protocol ID
- S22C14G92003
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Massage With TENS on Para Sacral Versus Sacral Area on Symptom Severity and Quality of Life in Severe Chronic Constipation Among Young Females
- ClinicalTrials.gov ID
- NCT06303011
- Acronym / sponsor ID
- S22C14G92003
- Conditions
- Constipation
- Keywords
- Constipation, Quality of life, Abdominal massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 12 Mar 2024 (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.
Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.
Detailed description
This study will be a Randomized Clinical trial and will be conducted at services Hospital in Lahore. The study will be completed with in the time duration of eight months. Purposive sampling technique will be used to collect the data. A sample size of Total 24 patients will be taken in this study. Patients will be divided into two groups.(Group A will be treated with TENS on sacral area and abdominal massage where as Group B will be treated with TENS on par sacral area and abdominal massage).PAC-SYM Questionaire,PAC-QOL Questionaire will be used to ask some questions related to patients 'symptoms and abdominal cramps or bloating.. All participants of the study will fill the PAC-SYMQ and PAC-QOL Q on day 1 as pre treatment values and at the end of 4th session as post treatment values respectively. The collected data will be analyzed on SPSS-25.
Keywords : constipation, Quality of life , abdominal massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group: A | Experimental | Other: Transcutaneous Electrical Nerve StimulatorTENS on sacral areas with Abdominal Massage |
| Group: B | Active comparator | Other: TENS on para sacral area with Abdominal MassageTENS on para sacral area with Abdominal Massage |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 14 -35year
- Only females
- Laxatives at least once or more for 2weeks
- Non pregnant
- Chronic Constipation more then 6 months
Key exclusion criteria (4 listed)
- Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions.
- Pregnant females suspected pregnant subjects, as well as those who were breast-feeding
- Non co-operative patients
- Female with underlying disease
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulatorTENS will be applied on sacral and parasacral area. Frequency 10Hz, Pulse duration 200μs, Stimulation duration 20min | Other | Group: A |
| TENS on para sacral area with Abdominal MassageTENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200μs Stimulation duration 20min | Other | Group: B |
Primary outcome
PAC-SYM Questionnaire
Time frame: 8 weeks
It is a self-reported questionnaire consisting of 12 symptoms divided into three domains: abdominal, rectal and stool, with responses rated on a. 5-point.The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined. PAC-SYM Questionnaire Validity is 0.68 to 0.72 and reliability is 0.75to 0.89
PAC-QOL Questionnaire
Time frame: 8 weeks
The following questions are designed to measure the impact constipation has had on your daily life over the past 2 weeks. The overall PAC-QOL score consisted of four domains: physical discomfort, psycho- social discomfort, satisfaction, and worries and concerns. A lower score indicated a better outcome for symptomatic relief and QOL. PAC-QOL Questionnaire Validity is 0.76 to 3.41 and reliability is >0.80.
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 22 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Faiza Taufiq, PPDPT principal investigator
Riphah International University, Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulator and TENS on para sacral area with Abdominal Massage in people with Constipation, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 4 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 22 Apr 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 Pakistan. 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?
PAC-SYM Questionnaire (time frame: 8 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 22 Apr 2024.