NCT04509518

Brief Summary

To study the efficacy of adding Transcutaneous Electrical Nerve Stimulation (TENS) to selected physical therapy exercise program on pain in patients with pudendal neuralgia. Fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this study. Methods: patients were assigned randomly into two groups equal in number; study and control groups with 26 patients in each. All patients were receiving the same physical therapy exercise program, in addition to the same prescribed analgesic medication. Patients in the study group received additional TENS therapy and those in the control group received sham TENS. Treatment was provided three sessions per week for twelve successive weeks. The participants underwent baseline and post treatment assessment for pain level as measured by three methods; Serum Cortisol Level (SCL), Daily Etodolac intake dose (DEID), and Numerical Pain Rating Scale (NPRS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

August 9, 2020

Last Update Submit

August 9, 2020

Conditions

Pudendal Neuralgia

Outcome Measures

Primary Outcomes (1)

  • Neumerical rating scale

    It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain"conditions tend to have higher values

    12 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Participants in the study group received exercise therapy program plus additional TENS therapy

Other: Exercise therapy program plus TENS therapy

Control group

OTHER

Participants in the study group received exercise therapy program plus sham TENS

Other: Exercise therapy program plus TENS therapy

Interventions

Exercise therapy program plus TENS therapyOTHER

All patients were receiving the same physical therapy exercise program, 3 times per week for 12 weeks in the form of pelvic floor relaxation exercises, diastasis correction exercises , myofascial trigger points release, connective tissue manipulation and progressive abdominal strengthening exercises. Pelvic floor relaxation exercises included pelvic floor release stretches, Proprioceptive Neuromuscular Facilitation technique, and pelvic floor drop exercises in addition to TENS therapy The standard protocol for TENS therapy in this group was 20 minutes of 100 Hz frequency, pulse duration of 200 µsec, three times a week for successive 12 weeks

Control groupStudy group

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nonsmoking male patients
  • Diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia
  • Ages ranged between 30 to 50 years
  • Did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training.

You may not qualify if:

  • Those who had history of skin malignancy
  • Diabetes
  • Sensory disorders
  • Circulatory insufficiency
  • Acute infection of the treatment area
  • Renal failure
  • Myocardial infarction
  • Communication problems, or those with pace maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 12, 2020

Study Start

February 10, 2018

Primary Completion

April 5, 2019

Study Completion

December 7, 2019

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Locations

EG(1)