Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202104532195177 Date of Approval: 21/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of integrated neuromuscular inhibition technique versus electro-acupuncture stimulation of posterior tibial nerve on myofascial male chronic pelvic pain
Official scientific title Impact of integrated neuromuscular inhibition technique versus electro-acupuncture stimulation of posterior tibial nerve on myofascial male chronic pelvic pain
Brief summary describing the background and objectives of the trial The practical work was done from June 2019 to May 2020. The Patient were referred to outpatient clinic of physical therapy, the referral from urological out-clinics. The patient's age was from 25 to 65. The patients assigned into 3 groups by single blind randomization, they classified to three groups of equal numbers by one-to-one way: The A group (20 patients) received integrated neuromuscular inhibition technique (INIT) and pelvic floor exercise, the B group (20 patients) received electroacupuncture on posterior tibial nerve as using acupuncture TENS as neuromodulation of pelvic floor muscle as noninvasive technique and pelvic floor exercise, controlled group (20 patients) received pelvic floor exercise only. The inclusive criteria were patients with chronic pelvic pain as complaints of pain at least 6 months in groin, genitals, upper part of lower abdomen, pelvic floor muscle spasm and perineal pain without clear abnormalities on urological examination. Exclusive Criteria were patients age under 25, symptoms exciting for less than 6 months, active or recurrent urinary tract infection, bladder or kidney stones, Bacterial prostatitis, severe cardiopulmonary disease, neurological disorder like (MS, stroke) and patients under analgesic treatment.9
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 30/06/2019
Actual trial start date 30/06/2019
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date 31/05/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A. This group was treated with INIT that include (ischemic compression technique, Strain counter strain and muscle energy technique) It is well documented that trigger points may produce pelvic pain; these trigger points can be found in the levator ani muscle group, obturator internus, coccygeus, abdominals, gluteals, adductors, iliotibial band, tensor fascia latae quadricep, piriformis and quadratus lumborum 12 weeks This group was treated with INIT that include (ischemic compression technique, Strain counter strain and muscle energy technique) It is well documented that trigger points may produce pelvic pain; these trigger points can be found in the levator ani muscle group, obturator internus, coccygeus, abdominals, gluteals, adductors, iliotibial band, tensor fascia latae quadricep, piriformis and quadratus lumborum 20
Experimental Group Group B Acupuncture transcutaneous electrical nerve stimulation (TENS) had been delivered to the posterior tibial nerve via a combination of electrode and generator components. Acupuncture needles (0.25 × 25 mm; Kungsholmsgatan, Sweden) were sited unilaterally at the Spleen (SP) 6 and Kidney (KI) 2 points 12 weeks the needles were then attached to TENS machine (Model DH-808, made by DAE Han in Korea). The low-voltage stimulator (9 volts) had an adjustable pulse intensity according to patient tolerance, a fixed pulse width of 200 microseconds and a frequency of 10Hz. The device produces an adjustable electrical impulse to acupuncture needle that travels to the sacral nerve plexus via the tibial nerve. The participant was instructed to increase the intensity to induce a motor and/or sensory response in the tibial nerve. 20
Control Group Group C 1, 25 cycles/day (5 min total); week 2, 50 cycles/day (10 min total); week 3, 75 cycles/day (15 min total); weeks 4–24, 100 cycles/day (20 min total). 12 weeks The pelvic floor muscle exercise program was based on contraction of the pelvic floor muscles for 6 s followed by rest for 6 s, resulting in 5 contraction cycles/min. The number of contraction cycles was increased 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with chronic pelvic pain as complaints of pain at least 6 months. patients with chronic pelvic pain in groin, genitals, upper part of lower abdomen, pelvic floor muscle spasm. patients with chronic pelvic pain without clear abnormalities on urological examination. patients age under 25. symptoms exciting for less than 6 months. active or recurrent urinary tract infection, bladder or kidney stones, Bacterial prostatitis. severe cardiopulmonary disease. neurological disorder like (MS, stroke) and patients under analgesic treatment. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/04/2019 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
been el sarayat giza 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Arabic version of the National Institutions of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) 0-43 points
Secondary Outcome serum cortisol level 9-35
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university hospitals gamaa street giza Egypt
haram hospital pyramids street giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud HamadaMohamed 4th discret giza 0020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mahmoud hamada 4th district street giza 0020 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
mahmoud hamada mohamed 4th discreet giza 0020 Egypt
mohamed naeem mohamed beni sueif cairo 0020 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud hamada dr.mahmoudhamada@acu.edu.eg 002001111750888 4th discreet street
City Postal code Country Position/Affiliation
giza 0020 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries mohamed naeem dr.mohamednaeem@yahoo.com 002001096968910 cairo
City Postal code Country Position/Affiliation
cairo 0020 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries kadry ahmed elnemera81@hotmail.com 002001111852447 cairo
City Postal code Country Position/Affiliation
cairo 0020 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sixty male patients diagnosed as pelvic pain with myofascial origin, refereed from urological department, one year of study period. An informed written consent of each participant was collected. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan immediately following publication, no end date any one wishing to access data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/04/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information