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.: PACTR202009541417744 Date of Approval: 04/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of simultaneous application of position release technique and Maitland mobilization technique on nerve conduction velocity at patients with sciatica.
Official scientific title The effect of simultaneous application of position release technique and Maitland mobilization technique on nerve conduction velocity at patients with sciatica.
Brief summary describing the background and objectives of the trial One the most common compailns in patients with low back pain LBP is sciatica. Sciatica is sensory manifestation of nerve root compression at lower lumbar spine. Low back pain is considered the major cause that make patients seek medical and physical therapy advise. Compression on nerve root is the main contributing case of sensory and motor radilcolpathy. This comprrsion comes from maniny factors as disc prolplse, canal stenosis and osteophystis. Spasm of piriforms muscle could csues sensory radicolpathy( scitica). The comprssion at nerve root comprmise the vas nervous the blood suuply source for the enrve which results on nerve ischmia which in turn make the nerve anouxous ( angry nerve) and by the end the patients compialns from sciatica. 60 patients diagnosied with low back pain with scitica will be recruited by the treating therapist from the out patient clinic at faculty of physical therapy cairo university .subjects were include in the study after signed a consent form and be educated about the whole procedure steps.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LBP INIT PRT
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2020
Actual trial start date 01/09/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group POSTION RELEASE TECHNIQUE AND MAITLAND MOBILIZATION TECHNIUQE treatemnt tecknique FIVE TIMES EACH SESSION THREE TIME PER WEEK 6 WEEK This program lasts for 3 sessions per week for 6 weeks. This group received the experimental treatment technique. This technique is the first time to be used through this paper. The technique includes the combination application of position release technique of the piriformis muscle and Maitland mobilization of L5-S1 segment during the treatment. We target the maximizing effect of both technique and safe patients and therapist time. Position release technique includes putting the muscles passively in shortened position for 90 seconds which induce immediate relaxation of the treated muscles. We applied this technique for the piriformis muscle of the affected leg. The patient lay prone laying position and the therapist stands at the pelvis level beside the affected leg. The patients leg moved outside the bed in hip and knee flexion. Then the moved in hip abduction and external rotation till a comfortable position achieved after that the leg rested on a smale chair beside the bed. This alignment put the leg in gravity dependent position which enhance the blood suplly for the scitic nerve and granted a rexation for piriformis which in turn decrease the compression on the sciatic nerve. This aligment should continue for 90 seconds and during this alignment we applied Maitland posterior anterior mobilization technique for L5-S1 segment which is the core of the treatment. This technique was received to the patients for 6 weeks in the pattern of three times per week it was associated with the traditional rehabilitation program. Maitland mobilization technique: The therapist locate the L5-S1 segment by palpating both iliac crest then go central to be at L4-L5 intervertebral disc. Then the therapist go further down to palpate L5 spine process. The patients use supported grasp which include the therapist support on hand web space and the other hand web space then the therapist rest the ulnar side of the lower hand on top of the spines process of L5.the therapist push down gent 30
Control Group sham treatment technique FIVE SESSION THREE TIME PER WEEK 6 WEEKS They received the same tradition physical therapy for 3 per week for 6 weeks and they received sham treating technique as comparison. The sham technique includes that patient was assuming prone lyiung position with the affects was rests on the small chair in hip and knee flexion position only. The therapist stands beside the patients pelvis and just palpte the patient lower lumbar spine without any mobilization manuvers and this lasts for 30 seconds. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-MALE 2- FEMALE 3-LOW BACK PAIN WITH SCIATICA 1-Invase surgery in lumbar spine 2-motor manifestation of lower limb as drop foot Diabetes mellitus rheumatoid arthritis previous history of tumor pregnancy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 45 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
No 25/08/2020 FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
7 ELZAYYTA ST DOKKI 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome NERVE CONDUCTION VELOCITY OF SCIATIC NERVE PRE AND POST
Secondary Outcome VAS PRE AND POST
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FACULTY OF PHYSICAL THERAPY CAIRO UNIVERSITY 7 ELZAYYAT ST DOKKI 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mahmoud diab 7th zayat dokki 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FACULTY OF PHYSICAL THERAP 7 ELZAYYAT ST DOKKI 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud diab 7th zayat street dokki 12511 Egypt
mohamed ibrahem 7th zayat dokki 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAHMOUD ABD elhaleem mahmoud.diab@pt.cu.edu.eg 01117750496 7th elzayyat
City Postal code Country Position/Affiliation
dokki 12511 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries mohamed abd elhay dr.mahmouddiab11@gmail.com 01126213339 7 elzayyat st
City Postal code Country Position/Affiliation
dokki 12511 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries eman mohamed eman_pt88@yahoo.com 01025806209 7 elzayyat st
City Postal code Country Position/Affiliation
dokki 12511 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the trail the nerve conduction velocity Informed Consent Form,Statistical Analysis Plan one year the critira will be accessed by the publication of trials in international journal
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 URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information