Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05531500 |
| Other study ID # |
pelvic pain outcome |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2022 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Assiut University |
| Contact |
Medhat SA Farghaly, Master |
| Phone |
2001095105568 |
| Email |
medhatsradwan[@]aun.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators aim from this study, to determine the safety and efficacy of pulsed
radiofrequency in the management of pudendal neuralgia, compared to current a standard
intervention, which is corticosteroid injection for PN, as part of multidisciplinary pain
management.
Description:
The aim of this study is toillustrate whether pulsed radiofrequency treatment is safe and
effective intreating the chronic perineal pain associated with PN or pudendal nerve
compression; and whether it can be used as an integral part of its multidisciplinary
managementBased on literature, the prevalence of Chronic Pelvic Pain (CPP) in general
population ranges between 5.7% and 26.6%(Ahangari, 2014). There are many countries and
regions with no published data in the field of CPP (Ahangari, 2014). CPP is a great burden to
the patients and the healthcare systems (Latthe et al., 2006). About £154 million was the
estimated cost of treatment for the women who suffer from CPP per year (Cheong and William
Stones, 2006). CPP affects one's movement and their posture due to the secondary hyperalgesia
in the pelvic muscles leading to diminished proprioception. About 50%- 70% of women with CPP
have limitation on their daily activity(Ahangari, 2014). PN occurs in men, but the
incidence/prevalence is not well studied. The principle therapy for chronic neuropathic pain
is to eliminate the underlying causes of the pain (Belgrade, 2003), for PN this may involve
surgical decompression. Pharmacotherapy and physiotherapy are two different options for
treatment of neuropathic pain but they each come with limitations and drawbacks. Different
techniques for pudendal nerve block have been described for managing PN but they have
complications that may be serious such, vascular injury or intravascular injection with
toxicity. The indication of surgery is in patients with failure of conservative treatment or
other PNB techniques / modalities and includes decompression or neuromodulation.
Type of the study: A retrospective randomized controlled study Study Setting: University
college London hospital
Sample Size Calculation:
Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007). A
calculated minimum sample of the cases is 60 patients, 30 in each group.
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
Total number of the cases is 60 patients, 30 in each group.
Intervention(s):
1. Informed written consent: - A copy of the signed Informed Consent form will be given to
the participant.
The original signed form will be retained at the study site and a copy placed in the
medical notes.
2. The patient is placed in the prone position
3. The ischial spine is then located using fluoroscopic X ray.
4. Aseptic cleaning of the skin in the target area
5. Patient will randomly be allocated to the control group receiving steroid and local
anaesthetic injection or treatment group receiving pulsed radiofrequency treatment and
local anaesthetic. Randomisation will be performed using sealed envelopes. I. Local
anaesthetic and corticosteroid injection (control group)
▪ Under X-Ray guidance, the Needle (22G 5-10 cm insulated radiofrequency needle) is
advanced perpendicular to the skin and placed transgluteally, directly avoiding the
adjacent sciatic nerve at either the extremity of the ischial spine between the
sacrotuberous and sacrospinous ligaments.
- Sensory Electrostimulationis used to identify the nerve. For the motor stimulation,
a unilateral contraction of the anal sphincter indicates that the inferior anal
nerve had been stimulated while for the sensory stimulation, a sensation of
tingling or numbness in the perineal region may be felt by the patient.
- Contrast injected to avoid intravascular injection. A blinded operator sets the
radiofrequency machine for a timer alert at five minutes.
- After confirming the exact location of the needle tip, 4 mL of 1% lidocaine and 3.3
of dexamethasone in 1 mL are injected. II. Pulsed radiofrequency
(Treatment/intervention group)
- Needle is placed using the same technique as above and contrast medium is injected.
- Lesion: - Radiofrequency current will be applied for 5 minutes, 120 ms, at 2 Hz,
with maximum tissue temperature increased to 42°C. (usually not felt by the
patient)
- 4 mL of 1% lidocaine and 1 mL of NaCl .9% are injected.
6. Post procedure instructions:- ▪ Standard post procedure monitoring for 1 hour in theatre
recovery, including treatment of nausea/vomiting and localized pain with standard
intravenous/oral medication.
- Immediate adverse events reporting.
- Standard hospital post procedure instructions
Research outcome measures:
1. Primary Endpoint:
Reduction in at least 1.5 point pain as measured by Numerical Rating Scale Secondary
Endpoint A. NRS at 0, 1 and 12 weeks B Quality of Life Assessment at baseline, week 1,
week 6 and week 12 a. EDQ5-5L b. SF-12 c. Brief Pain Inventory d. Global response
Assessment C. Mood assessment at baseline, week 6 and week 12
a. Pain Catastrophising Questionnaire b. Beck Depression Inventory II c. Hamilton
Anxiety Rating Scale d. Sexual function assessment (questionnaire) at baseline, weeks 6
and 12 e. Lower urinary tract symptom assessment at baseline, weeks 6 and 12 f. Bristol
Female Lower Urinary Tract Symptoms (BFLUTS-SF) g Review of pain medication use at weeks
6, 12 compared to baseline. h. Assessment of all patients against Nantes criteria at
baseline
2.5-Data management and analysis (Details needed): Data collection. Telephone review -
Week 1
1. Telephone review in 1 week to assess for complication and side effcte profile.
2. Global pelvic pain NRS scores over telephone.
3. Adverse events reporting.
b. Telephone review at 6 weeks and 12 weeks
1. review pelvic pain
2. Questionaires: global pelvic pain, QoL and function
3. Medication review
1. S - Study/Statistical design (e.g. randomised controlled trial, case control study,
pilot study):
2. Prospective
3. Parallel group ( 2 different groups)
4. No active Control
5. Randomized
6. Single blinded
7. multicentric study (at UCLH center)
Statistical methods:
i. All data will be collected and cleaned by Excel program then will be analyzed with
SPSS software (Statistical Package for the Social Sciences, version 16, SSPS Inc, and
Chicago, USA). ii. Continuous parametric data between two groups, two sample T test will
be used.
iii. Continuous parametric data between more than 2 groups, ANOVA test will be used.
iv. Descriptive statistics will be done in the form of mean and standard error (SE).
v. Frequency of qualitative variables and Chi-square test will be done. vi. In
Categorical data, Chi-squared test will be used.
