Primary DysmenorrheaNCT05439096
Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea
A study testing Functional Exercise and High Frequency Transcutaneous Electrical Nerve Stimulation in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Functional Exercise and High Frequency Transcutaneous Electrical Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 28 Jul 2022
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed instance of primary dysmenorrhea
- Age somewhere in the range of 18 and 30 years,
- A history of lower stomach torment for in excess of 6 periods.
- Moderate or serious torment, with a numeric rating scale (NRS) score ≥5 out of 10.
- No elective treatment including TENS inside multi month before enlistment in the investigation; and
- Provision of educated agree preceding enlistment in the examination.
Who cannot join
- Pregnant or Breastfeeding,
- History of medical procedure of the lower midsection,
- Heart sickness,
- Cancer,
- Severe mental problems.
- Those who couldn't utilize TENS, for instance, in view of a lasting pacemaker or skin infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Comparative Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Pain and Sleep Quality in Students With Primary Dysmenorrhea
The objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea.
Read the detailed description
A Randomized Control Trial study will be directed at Riphah International University Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist the patients. Patients will be enrolled according to the pre-characterized criteria. Sample size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The patients of one group will recieve exercise therapy and patients of other group will recieve high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be assessed following a month of treatment . Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences version 20.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Functional Exercise, High Frequency Transcutaneous Electrical Nerve Stimulation
- Keywords
- Functional Exercise, High Frequency, Transcutaneous Electrical Nerve Stimulation, Primary Dysmenorrhea, Menstrual Pain, Randomized Control Trial
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ExerciseOther
Among Functional Exercises, cobra position is most effective in reducing pelvic pain while others are cat and fish position.Kegel exercises along with other strengthening activities for pelvic floor muscles have been accounted for in writing to favorably affect primary dysmenorrheal.
High Frequency Transcutaneous Electrical Nerve StimulationOther
Transcutaneous electrical nerve stimulation, best treat primary dysmenorrhea. Transcutaneous Electrical Nerve Stimulation is proposed as an incredible spasm decrease, lessening torment, decline of analgesics and improving personal satisfaction in primary dysmenorrhea patients.
| Study group | Role | What they receive |
|---|---|---|
| Functional Exercise | Experimental | * 2 stretching exercises
* 1 yoga exercises
* 2 core strengthening exercises
* 2 pelvic area exercises
* Kegel exercises
* Warm up for 5 minutes the apply perform exercise 3 times a week for 8 weeks and 45 minutes duration at a time Receives: Other: Functional Exercise |
| High Frequency Transcutaneous Electrical Nerve Stimulation | Experimental | High frequency TENS by below mentioned parameters will be applied.
* Pulse waveform = Biphasic waveform
* Pulse recurrence = 50 to 120 Hz
* Phase duration = 100 µsec
* Current amplitudes = highest tolerable intensity with continuous adjustment
* Skin arrangement = flawless skin region.
* Type of electrodes = Self-adhesive
* Size and location of electrodes = It will be adjusted specifically to each woman according to the typical area of her pain. Receives: Other: High Frequency Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
A Visual Analogue Scale is a measurement instrument, Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Mar 2021
- Primary completion20 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439096
- Sponsor's protocol ID
- REC-FSD-00250
- Status last verified
- Mar 2023
- First submitted
- 27 Jun 2022
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Pain and Sleep Quality in Students With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05439096
- Acronym / sponsor ID
- REC-FSD-00250
- Conditions
- Primary Dysmenorrhea
- Keywords
- Functional Exercise, High Frequency, Transcutaneous Electrical Nerve Stimulation, Primary Dysmenorrhea, Menstrual Pain, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 30 Jun 2022 (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 objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea.
Detailed description
A Randomized Control Trial study will be directed at Riphah International University Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist the patients. Patients will be enrolled according to the pre-characterized criteria. Sample size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The patients of one group will recieve exercise therapy and patients of other group will recieve high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be assessed following a month of treatment . Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences version 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Exercise | Experimental | Other: Functional Exercise* 2 stretching exercises * 1 yoga exercises * 2 core strengthening exercises * 2 pelvic area exercises * Kegel exercises * Warm up for 5 minutes the apply perform exercise 3 times a week for 8 weeks and 45 minutes duration at a time |
| High Frequency Transcutaneous Electrical Nerve Stimulation | Experimental | Other: High Frequency Transcutaneous Electrical Nerve StimulationHigh frequency TENS by below mentioned parameters will be applied. * Pulse waveform = Biphasic waveform * Pulse recurrence = 50 to 120 Hz * Phase duration = 100 µsec * Current amplitudes = highest tolerable intensity with continuous adjustment * Skin arrangement = flawless skin region. * Type of electrodes = Self-adhesive * Size and location of electrodes = It will be adjusted specifically to each woman according to the typical area of her pain. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed instance of primary dysmenorrhea
- Age somewhere in the range of 18 and 30 years,
- A history of lower stomach torment for in excess of 6 periods.
- Moderate or serious torment, with a numeric rating scale (NRS) score ≥5 out of 10.
- No elective treatment including TENS inside multi month before enlistment in the investigation; and
Key exclusion criteria (6 listed)
- Pregnant or Breastfeeding,
- History of medical procedure of the lower midsection,
- Heart sickness,
- Cancer,
- Severe mental problems.
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 |
|---|---|---|
| Functional ExerciseAmong Functional Exercises, cobra position is most effective in reducing pelvic pain while others are cat and fish position.Kegel exercises along with other strengthening activities for pelvic floor muscles have been accounted for in writing to favorably affect primary dysmenorrheal. | Other | Functional Exercise |
| High Frequency Transcutaneous Electrical Nerve StimulationTranscutaneous electrical nerve stimulation, best treat primary dysmenorrhea. Transcutaneous Electrical Nerve Stimulation is proposed as an incredible spasm decrease, lessening torment, decline of analgesics and improving personal satisfaction in primary dysmenorrhea patients. | Other | High Frequency Transcutaneous Electrical Nerve Stimulation |
Primary outcome
Visual Analogue Scale
Time frame: 12th Week
A Visual Analogue Scale is a measurement instrument, Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
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 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
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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.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Exercise and High Frequency Transcutaneous Electrical Nerve Stimulation in people with Primary Dysmenorrhea, 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 6 inclusion and 6 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 9 Mar 2023. 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?
Visual Analogue Scale (time frame: 12th Week). 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 9 Mar 2023.