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.: PACTR201911908748188 Date of Approval: 04/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neural mobilization versus myofascial release after lumbar spine fusion.
Official scientific title Neural mobilization versus myofascial release to stabilization exercises after lumbar spine fusion: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Lumbar spine fusion largely (LSF) affects trunk muscles strength and endurance and some patients may still have pain and disability for months or years after surgery. Scar tissue formation is part of the normal healing process after back surgery and it can be a cause of pain. Neural mobilization and myofascial release improves pain and disability in patients with low back pain , but the effect of them after LSF remains uncertain. Objectives: this study will be conducted to investigate the effect of adding neural mobilization or myofascial release to stabilization exercises on pain and disability after lumbar spine fusion and compare them to each others.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/05/2019
Actual trial start date 10/06/2019
Anticipated date of last follow up 10/09/2019
Actual Last follow-up date 19/03/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Stabilization Exrecises 3 sessions per week 4 weeks The main goal in this exercise protocol is to restore and maintain the stability of the spine by retraining the main stabilizing muscles of the trunk through multi-step progressive stages. During the first session, the patients will be educated about the muscles involved in core stability. In addition, they will be taught movements that emphasize on the activation of central core stability muscles. Participants will learn the abdominal drawing-in maneuver (ADiM) and activation of lumbar paraspinal muscles (especially LM), as well as how to maintain them in static (supine and quadruped) positions. In subsequent sessions, muscle activation will be combined with other functional movements, and participants will learn how to retain the maneuver in dynamic positions (while sitting and moving the limbs in a controlled and slow motion on the floor or on a Swiss ball) and in normal physical actions during the day. 20 Active-Treatment of Control Group
Experimental Group Neural mobilization 3 sessions per week 4 weeks Neural mobilization will be given for approximately 12-15 minutes per session including 30 sec hold and 1 min rest. The straight leg raise will be done for inducing longitudinal tension (traction) at the sciatic nerve while maintaining extension at the knee. In order to induce dural motion through the sciatic nerve; the leg was raised past 35 degrees in order to take up slack in the nerve. Since the sciatic nerve is completely stretched at 70 degrees, pain beyond that point is usually of hip, sacroiliac, or lumbar spine origin. The unilateral straight leg raise causes traction on the sciatic nerve, lumbosacral nerve roots, and dura mater. To introduce additional traction (i.e., sensitization) into the proximal aspect of the sciatic nerve, hip adduction will be added to the straight leg raise. 20
Experimental Group Myofascial release 3 sessions per week 4 weeks Myofascial release will be applied to thoracolumbar fascia, Quadratus Lumborum, Piriformis and hamstring muscles. From prone lying position, counter pressure will be applied by one hand and the other hand will apply a slow stretch in the opposite direction till a tissue barrier is felt. A sustained pressure is applied into the restricted tissue barrier for about 90 – 120 seconds until release is felt. The therapist follows the release into a new tissue barrier and holds and so on until the tissue becomes softer and more pliable 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients of both genders with lumbar spine fusion with a primary diagnosis of spondylolisthesis or degenerative disc disease with or without spinal stenosis or chronic low back pain after previous surgery for disc herniation. 1. Previous lumbar fusion surgery. 2. Degenerative or idiopathic scoliosis. 3. Inflammatory disease and history of malignancy. 4. Paralysis. 5. Osteoporosis of the spine. 6. Primary joint disease such as active rheumatoid arthritis. 7. Metabolic bone disease. 8. Severe psychiatric disturbance. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 50 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 05/05/2019 Ethics committee of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat St. Beinelsarayat, Dokky, Giza Giza 12618 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Disability by Oswestry Disability Index immediate before starting treatment, immediate after finishing treatment and one month later
Secondary Outcome Pain by Visual Analogue Scale immediate before starting treatment, immediate after finishing treatment and one month later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethics committee of faculty of physical therapy cairo university 7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Elsayed Mohamed Ali Helal 20 Yathreb St., Sector 20 Sadat City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 Ahmed Elzayat St. BienElsarayat, Dokky, Giza Giza 12618 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohsen Mohamed ElSayyad 7 Ahmed Elzayat St. BienElsarayat, Dokky Giza Egypt
Nabil Mahmoud AbdelAal 7 Ahmed Elzayat St., BienElsarayat, Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Helal mohamedhelalpt@gmail.com +201206550332 20 yathreb St., Sector 20
City Postal code Country Position/Affiliation
Sadat Egypt Physiotherapist
Role Name Email Phone Street address
Public Enquiries Nabil Abdel Aal Nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed Elzayat St., BienElsarayat, Dokky
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Mohsen Elsayyad dr_sayyad1@hotmail.com +201019661445 7 Ahmed Elzayat St., BienElsarayat, Dokky
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Mohsen Elsayyad dr_sayyad@hotmail.com +201019661445 7 Ahmed Elzayat St., BienElsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Nabil AbdelAal nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed Elzayat St., BienElsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) Statistical Analysis Plan,Study Protocol 6 months following publication Anyone who wishes to access the 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 URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information