Pain, PostoperativeNCT03761862
Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation
An observational study of Pain, Postoperative and Neural Therapy of Huneke, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Neural Therapy of Huneke, Dysmenorrhea
- What is being tested?
- Neural Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Dec 2018
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who undergo bilateral tubal ligation admitted to the training and research hospital.
Who may be able to join
- Patients who undergo bilateral tubal ligation
Who cannot join
- Previous abdominal surgery
- Patients with diseases that could have neurologic complications (DM, SLE ...)
About this study
Official title: Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients
The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.
- Conditions
- Pain, Postoperative, Neural Therapy of Huneke, Dysmenorrhea, Dyspareunia, Sterilization, Tubal
- Being tested
- Neural Therapy
- Medical subject headings
- Pain, Postoperative, Dysmenorrhea, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural TherapyProcedure or surgery
Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.
| Study group | Role | What they receive |
|---|---|---|
| Control | The control group with bilateral tubal ligation Receives: Procedure: Neural Therapy | |
| Neural Therapy | The treatment group Receives: Procedure: Neural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe pain.
Measured: 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Jan 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761862
- Sponsor's protocol ID
- Neuraltherapyinbtl
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients
- ClinicalTrials.gov ID
- NCT03761862
- Acronym / sponsor ID
- Neuraltherapyinbtl
- Conditions
- Pain, Postoperative, Neural Therapy of Huneke, Dysmenorrhea, Dyspareunia, Sterilization, Tubal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Dec 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.
The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Neural TherapyThe control group with bilateral tubal ligation |
| Neural Therapy | – | Procedure: Neural TherapyThe treatment group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergo bilateral tubal ligation admitted to the training and research hospital.
Key inclusion criteria (1 listed)
- Patients who undergo bilateral tubal ligation
Key exclusion criteria (2 listed)
- Previous abdominal surgery
- Patients with diseases that could have neurologic complications (DM, SLE ...)
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 |
|---|---|---|
| Neural TherapyNeural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness. | Procedure or surgery | Control, Neural Therapy |
Primary outcome
Pain scores
Time frame: 1 year later
Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe 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 4 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Neural Therapy of Huneke, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 2 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 scores (time frame: 1 year later). 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 4 Dec 2018.