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.: PACTR201707001644767 Date of Approval: 20/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title IMPACT OF DIFFERENT NEURODYNAMIC TENSION TECHNIQUES ON H REFLEX OF SCIATIC NERVE
Official scientific title IMPACT OF DIFFERENT NEURODYNAMIC TENSION TECHNIQUES ON H REFLEX OF SCIATIC NERVE
Brief summary describing the background and objectives of the trial this study cover literature gap concerning the effect of different neurodynamic tension (NDT) techniques of(2 slump techniques (tensioner and slider), 2 straight leg raising techniques (1.distal slider: hip and knee flexion, ankle dorsiflexion and toes extension-2.proximal sliders: knee extension,ankle plantarflexion, toes flexion), and new innovation (piriformis technique) that utilize stretching exercise as NDT technique by putting patient in crook lying position, ipsilateral (hip external rotation 45 degree, knee flexed 90 degree, heel is rested on the other contralateral knee (loading on piriformis), asking to increase flexion of the ipsilateral hip by increasing the flexion of the contralateral hip (loading on sciatic nerve this will increasing tension of piriformis and sciatic nerve). then determine the effect of these different NDT techniques on motor neuron excitability of sciatic nerve in healthy subjects by measuring its H Reflex and H/M Ratio,to determine the best technique that can influence motor neuron excitability.this will help therapists who are involved in the prevention and management of peripheral nerve disorders, particularly those affecting the sciatic nerve and its branches. Information from this research will increase the understanding of the effect of NDT techniques on sciatic nerve excursion that can be expected in healthy people and help in using them as a prophylactic treatment for subjects who are susceptible to have sciatica due to their life style. Furthermore, therapists can use this technique to enhance the rehabilitation period and decrease the duration of treatment, in addition this will influence the patients economically by decreasing the number of sessions required for treatment. Also it will provide clinicians¿ greater knowledge of physiological effects associated with the movement of nerves in the lower limb.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ND
Disease(s) or condition(s) being studied effect of neurodynamic tension techniques on H reflex and H/M ratio of sciatic nerve in normal subjects
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/04/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 12/09/2016
Actual Last follow-up date 02/10/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?_nfpb=true&_pageLabel=portals_app_atmregistry_portal_page_38
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group straight leg raising(distal slider) this whole NDT technique is done 2 times( one time with oscillation of hip and ankle joint and other time without oscillation) the NDT technique hold for 30 second and repeated 5 times and this procedure is done one tie with oscillation and the other time without oscillation subject supine lying, hip is 45° flexed, knee flexed with ankle dorsiflexed and toes extended and hold in this position for 30 seconds 5 times and make the whole procedure one time with oscillation of hip and ankle joint and the other time without oscillation then measure H reflex and H/M ratio of sciatic nerve using EMG apparatus 3 times,(before, after NDT,after NDT with oscillation) 20
Experimental Group slump technique (slider mobilization) this whole NDT technique is done 2 times( one time with oscillation of hip and knee joint and other time without oscillation)then measure H reflex and H/M ratio after both times the technique repeated again and again for 10 minutes approximatly once without oscillation then with oscillation passive knee extension (from 80º flexion to 20° flexion measured by universal goniometer and active cervical extension (from full comfortable cervical flexion to full comfortable cervical extension then measure H reflex and H/M ratio using EMG apparatus 3 times,(before, after NDT,after NDT with oscillation) 20
Experimental Group slump technique (tensioner mobilization) this whole NDT technique is done 2 times( one time with oscillation of hip and ankle joint and other time without oscillation) the NDT technique hold for 30 second and repeated 5 times and this procedure is done one tie with oscillation of (knee joint extension and cervical flexion) and the other time without oscillation passive knee extension (from 80º flexion to 20° flexion measured by universal goniometer and active cervical flexion (from full comfortable cervical extension to full comfortable cervical flexion then measure H reflex and H/M ratio using EMG apparatus 3 times,(before, after NDT,after NDT with oscillation) 20
Experimental Group piriformis neural mobilization technique this whole NDT technique is done 2 times( one time with oscillation of hip and ankle joint and other time without oscillation) the NDT technique hold for 30 second and repeated 5 times and this procedure is done one tie with oscillation and the other time without oscillation crook lying position, hip 45° external rotation, knee flexed 90°, heel is rested on the other knee (loading on piriformis)asking to increase flexion of hip (loading on sciatic nerve)whole procedure done one time with oscillation of hip joint and the other time without oscillation then measure H reflex and H/M ratio using EMG apparatus 3 times,(before, after NDT,after NDT with oscillation) 20
Experimental Group straight leg raising(proximal slider) this whole NDT technique is done 2 times( one time with oscillation of hip and ankle joint and other time without oscillation)then measure H reflex and H/M ratio after both times the technique repeated again and again for 10 minutes approximatly once without oscillation then with oscillation subject supine lying, hip is 45° flexed, knee extended with ankle plantarlexed and toes flexed and hold in this position for 30 seconds 5 times and make the whole procedure done one time with oscillation of hip and ankle joint and the other time without oscillation then measure H reflex and H/M ratio of sciatic nerve using EMG apparatus 3 times,(before, after NDT,after NDT with oscillation) 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Body Mass Index (BMI) doesn¿t exceed 25 kg/m2 2) No complaint from back pain 3) No history of surgery in the back 4) No significance difference in demographical data. 1) Pregnancy 2) Sciatica 3) Total or partial hip replacement 20 Year(s) 30 Year(s) Both
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 02/08/2016 cairo university
Ethics Committee Address
Street address City Postal code Country
el-tahrir st. infront of ben el-sarayat traffic-dokki- Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurment of H reflex and H/M ratio usinf EMG apparatus 1- before making the intervention. 2-after making each one of intervention and hold it for 30 seconds and repeat it 5 times. 3- after making each one of intervention with oscillation and hold it for 30 seconds and repeat it 5 times.
Secondary Outcome determinethe effect of different NDT techniques on motor neuron excitability after measuring the H reflex and H/M ratio before and after the application of NDT technique and compare between the 2 results
Secondary Outcome determine the best technique that can influence motor neuron excitability. by comparing between the measures of H reflex and H/M ratio of the 5 NDT techniques and choose the best technique between them that can influence the motor neuron excitability
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
asid 14th may road alexandria 21311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy cairo university el-tahrir st. in front of ben elsarayat traffic- dokki- giza giza 11432 Egypt
faculty of physical therapy pharos university kanal almahmoudeya st. Smouha alexandria 21311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university el-tahrir st. in front of ben elsarayat traffic- dokki- giza giza 11432 Egypt University
Primary Sponsor faculty of physical therapy pharos university kanal al mahmoudeya st. Smouha alexandria 21311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
basma mohammed ibrahiem smouha, asid compound, building 6, floor 9, flat 5 alexandria 21311 Egypt
basma mohammed ibrahiem smouha, asid compound, building 6, floor 9, flat 5 alexandria 21311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator basma ibrahiem dr.basma@yahoo.com 002-01004512344 smouha-14th may road-asid compound
City Postal code Country Position/Affiliation
alexandria 21311 Egypt assistant lecturer in faculty of physical therapy pharos university
Role Name Email Phone Street address
Principal Investigator basma ibrahiem dr.basma@yahoo.com 002-01004512344 asid compound-14th may road-smouha
City Postal code Country Position/Affiliation
alexandria 21311 Egypt assistant lecturer in faculty of physical therapy-pharos university
Role Name Email Phone Street address
Public Enquiries basma ibrahiem dr.basma_ib@yahoo.com 00201004512344 asid compound-14th may road-smouha
City Postal code Country Position/Affiliation
alexandria Egypt assistant lecturer in faculty of physical therapy-pharos university
Role Name Email Phone Street address
Scientific Enquiries basma ibrahiem dr.basma_ib@yahoo.com 00201004512344 asid compound-14th may road-smouha
City Postal code Country Position/Affiliation
alexandria 21311 Egypt assistant lecturer in faculty of physical therapy-pharos university
REPORTING
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