Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy

Cairo University (CU)

Status: Completed

Conditions: Post Prostatectomy; Pudendal Neuralgia; Transcutaneous Electrical Nerve Stimulation

Treatments: Device: Acupuncture-like) transcutaneous Electrical Nerve Stimulation; Drug: Gabapentin; Device: conventional Transcutaneous Electrical Nerve Stimulation; Other: Traditional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07348952

Mohamed-Phd

Details and patient eligibility

About

The purpose of this study was to evaluate the therapeutic efficacy of two different Transcutaneous Electrical Nerve Stimulation modes in improving the pudendal neuralgia and its intractable perineal pain.

Full description

The need for this study will be developed from the lack in quantitative knowledge and information in the published studies about the effects of two different transcutaneous electrical nerve stimulation modes in cases of pudendal neuralgia. The significance of this study will be raised from the persistence of this neuralgia and its intractable pain that may result in severe morbidity with repeated local injections, pain medications and numerous surgical attempts to alleviate pain as well as the increase in the period of hospitalization plus the delay in returning to normal life. So, this study will be conducted to add new information about the effect of different transcutaneous electrical nerve stimulation modes in relieving chronic pudendal neuralgia post-prostatectomy, which may help the field of physical therapy and patients suffering from pudendal neuralgia.

Enrollment: 60 patients

Sex: Male

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients will be chosen after a routine medical examination.
• All patients will be approximately the same age (from 50-60 years old).
• All patients have chronic pudendal neuralgia post-prostatectomy surgery.
• They have not take another physical therapy electro- modality except the traditional physical therapy in the form of pelvic floor exercises.
• All of them will be non smokers and will be under own prescribed medications described by their physicians.
• The pain is located in the pudendal nerve distribution area.
• Pain intensity increased in the sitting position.
• There were no symptoms of nocturnal pain.
• Pain with no objective sensory impairment.
• Pain was relieved by diagnostic pudendal nerve block.
• Another clinical standard provides extra support to the diagnosis of pudendal neuralgia.
• Pain symptoms may be associated with sexual dysfunction.

Exclusion criteria

• Patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or having imaging anomalies that may explain the symptoms.
• Patients who take anticoagulant drugs or have any coagulation disorder.
• Patients who will be unable to complete the study.
• Patients with pain, which is caused by malignant or autoimmune diseases.
• Patients with life threatening disorders as renal failure, myocardial infarction or others will be excluded from the study.
• Patients who suffering from skin diseases, diabetes, varicose veins, trauma and peripheral vascular diseases will be excluded.
• Patients who suffering from myasthenia gravis, hyperthyroidism, hemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

conventional Transcutaneous Electrical Nerve Stimulation

Experimental group

Description:

was composed of 30 patients who received the conventional transcutaneous electrical nerve stimulation in addition to the traditional physical therapy and medical care for 3 months.

Treatment:

Other: Traditional physical therapy

Device: conventional Transcutaneous Electrical Nerve Stimulation

Drug: Gabapentin

Acupuncture-like) transcutaneous Electrical Nerve Stimulation

Active Comparator group

Description:

that was composed of 30 patients who received the SLR (Acupuncture-like) transcutaneous Electrical Nerve Stimulation in addition to the traditional physical therapy and medical care for 3 months

Treatment:

Other: Traditional physical therapy

Drug: Gabapentin

Device: Acupuncture-like) transcutaneous Electrical Nerve Stimulation