Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia
Primary Purpose
Pudendal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise therapy program plus TENS therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pudendal Neuralgia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study group
Control group
Arm Description
Participants in the study group received exercise therapy program plus additional TENS therapy
Participants in the study group received exercise therapy program plus sham TENS
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509518
Brief Title
Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia
Official Title
The Effectiveness of Selected Physical Therapy Exercise Program With or Without Transcutaneous Electrical Nerve Stimulation on Male Patients With Pudendal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
December 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pudendal Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Participants in the study group received exercise therapy program plus additional TENS therapy
Arm Title
Control group
Arm Type
Other
Arm Description
Participants in the study group received exercise therapy program plus sham TENS
Intervention Type
Other
Intervention Name(s)
Exercise therapy program plus TENS therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Neumerical rating scale
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia
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