Primary DysmenorrheaTENSinPainNCT03446859
TENS on Pain Intensity in Primary Dysmenorrhea
A study testing TENS in people with Primary Dysmenorrhea, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial summary
Dysmenorrhoea is a common problem in women of reproductive age. It is associated with painful uterine contractions and discomfort. The primary aim of the study was to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity associated with primary dysmenorrhoea among female… Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNigeria
- Study dates
- 4 Aug 2017to 16 Feb 2018
- 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 16 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants with primary dysmenorrhoea, who is single, between the ages of 16 to 30 and have no history of conception, the primary dysmenorrhoea should be at least for five days.
Who cannot join
- Individuals presenting with pelvic diseases.
- Individuals with cardiac problem.
- Undergraduate with primary dysmenorrhoea but with history of conception.
- Undergraduate with primary dysmenorrhoea currently using analgesia for pain relief.
- Undergraduate with primary dysmenorrhoea not up to five days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Amelioration of Pain Associated With Primary Dysmenorrhea in Female Undergraduates of a Nigerian University
Dysmenorrhoea is a common problem in women of reproductive age. It is associated with painful uterine contractions and discomfort. The primary aim of the study was to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity associated with primary dysmenorrhoea among female undergraduate students of Obafemi Awolowo University.
The study involved 50 females undergraduates of Obafemi Awolowo University with primary dysmenorrhoea lasting for at least 5 days. They were allocated in to two groups equally. One group was treated with TENS and other group served as control. The treatment was for 5 days and Pain intensity was measured before and after the treatment in the two groups. The post treatment pain intensity was then compared.
Read the detailed description
Subjects
Participants for this study were female undergraduates of OAU presenting with primary dysmenorrhoea.
Sample size determination
Sample size calculation was performed using the following equation: n = (Z2 P (1-P))/(d2), where n = sample size, Z = Z statistic corresponding to a chosen level of confidence, P = expected prevalence, and d = precision. In the calculation; Z will be= 0.9, P= 0.19 and d= 0.05. This calculation will result in a sample size of 50. TENS will be applied for 25 participants and 25 for control.
Sampling technique
A purposive sampling was use to select the Obafemi Awolowo University female students among the undergraduate (participants are volunteers). The consent of the participants were obtained.
Research design It is a true experimental study.
Instrument - Transcutaneous electrical nerve stimulation (MH6000 Combo, MH6100 EMS, MH6200 TENS) manufactured by Medihightec Medical Co., LTD 30175 Hannover, Germany.
- Electrodes (a squared shaped 40 by 40 MM made in the USA).
- Cotton wool
- Methylated Spirit
- Couch
- A Visual Analogue Scale (VAS) (10 Point numerical scale) to rate pain perception of the subjects.
Procedure
Ethical approval was obtained from Health and Ethic Research Committee of Institute of Public Health, Obafemi Awolowo University. Subjects were randomly allocated to two groups. TENS group of 25 and the control of 25. The subjects in the Experimental group was placed in supine lying in a comfortable position as possible. The abdomen to the inguinal region was decently exposed, cleaned using methylated spirit and cotton wool for electrode placement, after inspection of the area for cuts, skin infections or any abnormalities. The absence of such skin conditions as well as intact skin sensation indicates suitability for further procedures. A pair of electrodes ( inactive electrodes) was placed a little below the umbilicus ( Right and Left) and the other pair(active electrode) along the inguinal region at the level of pubic symphysis ( Right and Left) according to. A quadripolar method was used for electrode placement.
Before the commencement of the procedure the subjects was educated about Visual Analogue Scale (VAS).This include how to indicate their pain level. The treatment period lasted for 30 minutes for each treatment sessions and it is once a day for a period of three days that is for the 1st, 3rd and 5th day . The other group did not receive TENS, they served as control. Pain intensity was assessed on the first, 3rd and 5th day from the two groups. Dependent t test was used to compare the mean value of pain intensity within the group on first and 5th day and independent t test was used to compare the mean value of pain intensity on the first day and 5th day between Experimental and control group. Alpha level was set at 0.05
- Conditions
- Primary Dysmenorrhea
- Being tested
- TENS
- Keywords
- Transcutaneous nerve electrical stimulation,, Pain intensity, Primary dysmenorrhea, Female, Undergraduates
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSOther
Also called Experimental
First, there was explanation of the overall test procedure. The subject was placed in supine lying in a comfortable position.A pair of electrodes (inactive electrodes) was placed a little below the umbilicus (Right and Left) and the other pair (active electrode) along the inguinal region at the level of pubic symphysis (Right and Left) according to (Akinbo et al 2000).
The TENS equipment was switched on and the intensity was set at a level tolerable by each participant's. The treatment period lasted for 30 minutes for each treatment sessions and the procedure was carried out once a day on the 1st, 3rd and 5th days (Akinbo et.al 2000). Pain intensity was measured pre treatment and post treatment each day of treatment using the visual analogue scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | It consists of 25 subjects with primary dysmenorrhea which were put on TENS for 30 minutes, three for 3 days. The subject were placed in supine lying in a comfortable position as possible. The abdomen to the inguinal region were decently exposed and cleaned, after inspection of the area for cuts, skin infections or any abnormalities. A pair of electrodes ( inactive electrodes) will be placed a little below the umbilicus ( Right and Left) and the other pair(active electrode) along the inguinal region at the level of pubic symphysis ( Right and Left) according to (Akinbo et al 2000). A quadripolar method will be used for electrode placement. Receives: Other: TENS |
| Control | No intervention | These are 25 subjects which were not in any intervention. These were subjects that were not placed on TENS and were not used to drug taken for the amelioration of the dysmenorrhea. They were educated on the purpose of research and their inform consent was obtained. Their pain intensity was measured firs, third and 5th days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
The scale is from 0-5. 0 is no pain 3 is severe pain and 5 is excruciating pain
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start4 Aug 2017
- Primary completion10 Nov 2017
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects were randomly allocated to two groups, experimental and control
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
- Investigators
- Adesola O Ojoawo, PhD, Principal investigator, Obafemi Awolowo University, Ile Ife. Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446859
- Sponsor's protocol ID
- OJO/2018/001
- Acronym
- TENSinPain
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45.
PubMed 15493566Adams JM, Taylor AE, Schoenfeld DA, Crowley WF Jr, Hall JE. The midcycle gonadotropin surge in normal women occurs in the face of an unchanging gonadotropin-releasing hormone pulse frequency. J Clin Endocrinol Metab. 1994 Sep;79(3):858-64. doi: 10.1210/jcem.79.3.7521353.
PubMed 7521353
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Amelioration of Pain Associated With Primary Dysmenorrhea in Female Undergraduates of a Nigerian University
- ClinicalTrials.gov ID
- NCT03446859
- Acronym / sponsor ID
- TENSinPain / OJO/2018/001
- Conditions
- Primary Dysmenorrhea
- Keywords
- Transcutaneous nerve electrical stimulation,, Pain intensity, Primary dysmenorrhea, Female, Undergraduates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 27 Feb 2018 (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.
Dysmenorrhoea is a common problem in women of reproductive age. It is associated with painful uterine contractions and discomfort. The primary aim of the study was to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity associated with primary dysmenorrhoea among female undergraduate students of Obafemi Awolowo University.
The study involved 50 females undergraduates of Obafemi Awolowo University with primary dysmenorrhoea lasting for at least 5 days. They were allocated in to two groups equally. One group was treated with TENS and other group served as control. The treatment was for 5 days and Pain intensity was measured before and after the treatment in the two groups. The post treatment pain intensity was then compared.
Detailed description
Subjects
Participants for this study were female undergraduates of OAU presenting with primary dysmenorrhoea.
Sample size determination
Sample size calculation was performed using the following equation: n = (Z2 P (1-P))/(d2), where n = sample size, Z = Z statistic corresponding to a chosen level of confidence, P = expected prevalence, and d = precision. In the calculation; Z will be= 0.9, P= 0.19 and d= 0.05. This calculation will result in a sample size of 50. TENS will be applied for 25 participants and 25 for control.
Sampling technique
A purposive sampling was use to select the Obafemi Awolowo University female students among the undergraduate (participants are volunteers). The consent of the participants were obtained.
Research design It is a true experimental study.
Instrument - Transcutaneous electrical nerve stimulation (MH6000 Combo, MH6100 EMS, MH6200 TENS) manufactured by Medihightec Medical Co., LTD 30175 Hannover, Germany.
- Electrodes (a squared shaped 40 by 40 MM made in the USA).
- Cotton wool
- Methylated Spirit
- Couch
- A Visual Analogue Scale (VAS) (10 Point numerical scale) to rate pain perception of the subjects.
Procedure
Ethical approval was obtained from Health and Ethic Research Committee of Institute of Public Health, Obafemi Awolowo University. Subjects were randomly allocated to two groups. TENS group of 25 and the control of 25. The subjects in the Experimental group was placed in supine lying in a comfortable position as possible. The abdomen to the inguinal region was decently exposed, cleaned using methylated spirit and cotton wool for electrode placement, after inspection of the area for cuts, skin infections or any abnormalities. The absence of such skin conditions as well as intact skin sensation indicates suitability for further procedures. A pair of electrodes ( inactive electrodes) was placed a little below the umbilicus ( Right and Left) and the other pair(active electrode) along the inguinal region at the level of pubic symphysis ( Right and Left) according to. A quadripolar method was used for electrode placement.
Before the commencement of the procedure the subjects was educated about Visual Analogue Scale (VAS).This include how to indicate their pain level. The treatment period lasted for 30 minutes for each treatment sessions and it is once a day for a period of three days that is for the 1st, 3rd and 5th day . The other group did not receive TENS, they served as control. Pain intensity was assessed on the first, 3rd and 5th day from the two groups. Dependent t test was used to compare the mean value of pain intensity within the group on first and 5th day and independent t test was used to compare the mean value of pain intensity on the first day and 5th day between Experimental and control group. Alpha level was set at 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects were randomly allocated to two groups, experimental and control
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Other: TENSIt consists of 25 subjects with primary dysmenorrhea which were put on TENS for 30 minutes, three for 3 days. The subject were placed in supine lying in a comfortable position as possible. The abdomen to the inguinal region were decently exposed and cleaned, after inspection of the area for cuts, skin infections or any abnormalities. A pair of electrodes ( inactive electrodes) will be placed a little below the umbilicus ( Right and Left) and the other pair(active electrode) along the inguinal region at the level of pubic symphysis ( Right and Left) according to (Akinbo et al 2000). A quadripolar method will be used for electrode placement. |
| Control | No intervention | –These are 25 subjects which were not in any intervention. These were subjects that were not placed on TENS and were not used to drug taken for the amelioration of the dysmenorrhea. They were educated on the purpose of research and their inform consent was obtained. Their pain intensity was measured firs, third and 5th days |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants with primary dysmenorrhoea, who is single, between the ages of 16 to 30 and have no history of conception, the primary dysmenorrhoea should be at least for five days.
Key exclusion criteria (5 listed)
- Individuals presenting with pelvic diseases.
- Individuals with cardiac problem.
- Undergraduate with primary dysmenorrhoea but with history of conception.
- Undergraduate with primary dysmenorrhoea currently using analgesia for pain relief.
- Undergraduate with primary dysmenorrhoea not up to five days.
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 |
|---|---|---|
| TENSAlso: ExperimentalFirst, there was explanation of the overall test procedure. The subject was placed in supine lying in a comfortable position.A pair of electrodes (inactive electrodes) was placed a little below the umbilicus (Right and Left) and the other pair (active electrode) along the inguinal region at the level of pubic symphysis (Right and Left) according to (Akinbo et al 2000). The TENS equipment was switched on and the intensity was set at a level tolerable by each participant's. The treatment period lasted for 30 minutes for each treatment sessions and the procedure was carried out once a day on the 1st, 3rd and 5th days (Akinbo et.al 2000). Pain intensity was measured pre treatment and post treatment each day of treatment using the visual analogue scale (VAS). | Other | TENS |
Primary outcome
Visual analogue scale
Time frame: 5 days
The scale is from 0-5. 0 is no pain 3 is severe pain and 5 is excruciating 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 27 Feb 2018.
- Background: PubMed 15493566Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45.
- Results publication: PubMed 7521353Adams JM, Taylor AE, Schoenfeld DA, Crowley WF Jr, Hall JE. The midcycle gonadotropin surge in normal women occurs in the face of an unchanging gonadotropin-releasing hormone pulse frequency. J Clin Endocrinol Metab. 1994 Sep;79(3):858-64. doi: 10.1210/jcem.79.3.7521353.
- Individual participant dataSharing planned: No. No plan
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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.
Adesola O Ojoawo, PhD principal investigator
Obafemi Awolowo University, Ile Ife. Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Primary Dysmenorrhea, run by Obafemi Awolowo University at 1 site in Nigeria.
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 1 inclusion and 5 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 27 Feb 2018. 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 Nigeria. 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: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446859, which also lists 2 linked publications.
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 27 Feb 2018.