Pudendal NeuralgiaTENSNCT04455659
Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
A study testing Trans-cutaneous Electrical Nerve Stimulation and Conventional physical therapy exercise in people with Pudendal Neuralgia, run by Cairo University at 1 site in Egypt.
Trial summary
Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell… Read more about this study
- Who is it for?
- Ages 30 to 50 years, men only
- Conditions the study is for
- Pudendal Neuralgia
- What is being tested?
- Trans-cutaneous Electrical Nerve Stimulation and Conventional physical therapy exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2019to 25 May 2020
- 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 30 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male with ages ranged from 30 to 50 years.
- Suffering from pudendal neuralgia and its intractable perineal pain that persists for a minimum one month beyond the acute onset.
- Pelvic pain with sitting that relived by standing or toilet sitting.
- Anal pain, dyspareunia and genital pain
Who cannot join
- Those who had history of skin malignancy.
- Diabetic,
- Sensory disorders,
- Circulatory insufficiency
- Acute infection of the treatment area,
- Renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell exercise, relaxation exercise and underwater exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received only the traditional physical therapy exercise for the same period of time. Intensity of pain by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake are measured pre and post treatment.
- Conditions
- Pudendal Neuralgia
- Being tested
- Trans-cutaneous Electrical Nerve Stimulation, Conventional physical therapy exercise
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-cutaneous Electrical Nerve StimulationDevice
Also called Conventional physical therapy exercise
TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode
Conventional physical therapy exerciseProcedure or surgery
physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times
| Study group | Role | What they receive |
|---|---|---|
| TENS + Conventional physical therapy exercise | Experimental | Not described Receives: Device: Trans-cutaneous Electrical Nerve Stimulation; Procedure: Conventional physical therapy exercise |
| conventional physical therapy exercise | Active comparator | Not described Receives: Procedure: Conventional physical therapy exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (NRS)
Numeric Rating Scale (NRS) for pain is a one-dimensional measure of pain intensity in adults, including those with chronic pain .It is an instrument tool to measure the intensity of pain, Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
Measured: 8 weeks of treatment
Secondary outcomes (2)
Serum cortisol level
A venous blood sample of 8 CC was taken at the morning, centrifuged and stored at 20ºC till analyzed, Normal cortisol level ranged from 9-25 µg/dL at morning and patients with painful conditions tended to have higher than normal SCL
Measured: 8 weeks of treatment
Calculation of Etodolac Intake (ELI) in mg
It was done before and after the treatment program
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start20 Jan 2019
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455659
- Sponsor's protocol ID
- 1720
- Acronym
- TENS
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will share study protocol after 6 months from publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
- ClinicalTrials.gov ID
- NCT04455659
- Acronym / sponsor ID
- TENS / 1720
- Conditions
- Pudendal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 2 Jul 2020 (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.
Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell exercise, relaxation exercise and underwater exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received only the traditional physical therapy exercise for the same period of time. Intensity of pain by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake are measured pre and post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS + Conventional physical therapy exercise | Experimental | Device: Trans-cutaneous Electrical Nerve Stimulation, Procedure: Conventional physical therapy exercise |
| conventional physical therapy exercise | Active comparator | Procedure: Conventional physical therapy exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male with ages ranged from 30 to 50 years.
- Suffering from pudendal neuralgia and its intractable perineal pain that persists for a minimum one month beyond the acute onset.
- Pelvic pain with sitting that relived by standing or toilet sitting.
- Anal pain, dyspareunia and genital pain
Key exclusion criteria (6 listed)
- Those who had history of skin malignancy.
- Diabetic,
- Sensory disorders,
- Circulatory insufficiency
- Acute infection of the treatment area,
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 |
|---|---|---|
| Trans-cutaneous Electrical Nerve StimulationAlso: Conventional physical therapy exerciseTENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode | Device | TENS + Conventional physical therapy exercise |
| Conventional physical therapy exercisephysical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times | Procedure or surgery | TENS + Conventional physical therapy exercise, conventional physical therapy exercise |
Primary outcome
Pain intensity (NRS)
Time frame: 8 weeks of treatment
Numeric Rating Scale (NRS) for pain is a one-dimensional measure of pain intensity in adults, including those with chronic pain .It is an instrument tool to measure the intensity of pain, Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
2 secondary outcomes
Serum cortisol level
Time frame: 8 weeks of treatment
Calculation of Etodolac Intake (ELI) in mg
Time frame: 8 weeks of treatment
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 2 Jul 2020.
- Individual participant dataSharing planned: Yes. we will share study protocol after 6 months from publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-cutaneous Electrical Nerve Stimulation and Conventional physical therapy exercise in people with Pudendal Neuralgia, run by Cairo University at 1 site in Egypt.
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 4 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 2 Jul 2020. 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 Egypt. 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?
Pain intensity (NRS) (time frame: 8 weeks of treatment). 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 2 Jul 2020.