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.: PACTR202308709555945 Date of Approval: 25/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Lumbar Proprioceptive Training on Cortisol, Proinflammatory Cytokines, Pain and Functional ability in Patients with Lumbar Radiculopathy.
Official scientific title Effect of Lumbar Proprioceptive Training on Cortisol, Proinflammatory Cytokines, Pain and Functional ability in Patients with Lumbar Radiculopathy.
Brief summary describing the background and objectives of the trial Lumbar radiculopathy causes loss of work force. It is considered a significant health problem.Proprioceptive impairment alters the motor control a, the timing and accuracy of motor signals and leads to postural and muscular activity changes. This reduces the stability of the spine and increases the load on the spine. Isokinetic exercises improve the strength of muscles in different musculoskeletal disorders. The purpose of the current study is to investigate the effect of lumbar proprioception training on both cortisol and pro inflammatory cytokines in addition to pain and functional ability in lumbar radiculopathy patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/11/2022
Actual trial start date 10/11/2022
Anticipated date of last follow up 30/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 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 isokinetic dynamometer device and selected physical therapy program three times per week for six consecutive weeks The patients were given five to ten minutes to warm up by walking before starting treatment. Patients were asked to assume sitting position in the Biodex isokinetic dynamometer and their lower extremities were stabilized by thigh and tibial pads. The spinal range of motion was adjusted between 30-degree flexion and 15-degree hyperextension as recorded through the Biodex system. Patients were exercised at speed 60 degree/second, 120 degree/second, and180degree/second for five repetitions in each velocity with a rest period of 20 seconds between each speed. The patient was blind folded to eliminate visual input during exercise. The researcher asked the patient to move trunk from the initial position to the angle being demonstrated by the dynamometer and then to return the trunk to the initial position. The patients were asked to remember the position that was demonstrated and then return again the trunk to that position. selected physical therapy program (electrical stimulation as transcutaneous electrical nerve stimulation (TENS),ultra sound (US) and lumbar core stability exercise. 15
Control Group selected physical therapy program three times per week six weeks selected physical therapy program :transcutaneous electrical stimulation (TENS) and ultrasound and lumbar spine stability exercises. The TENS was applied for 15 minutes. The patient lied prone then four electrodes were placed on lumbar spine, the burst mode was used, with twenty sec duration and interval time three seconds, and the intensity was 20-50 mA . The Ultrasound was used for five minutes with parameters 1w/cm2 with frequency of 1 MHZ in continuous mode over paravertebral low back region. The program of lumbar spine stability exercise consisted of curl up, bridge, prone and side bridge, bridge with knee extension, and quadruped exercises for 20 to 25 minutes according to the physical ability of each patient. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) The patients with (L4, L5) (L5, S1) disc herniation with radiculopathy referred from neurological or orthopedic department after doing MRI of lumbar spine. 2) Patients age ranged from 30 -45 years old. 3) The duration from onset of pain was from 3-12 months. 4) The selected patients in the study were ambulant independently. 1) Patients with any pathology preventing neural tissue testing (eg: restriction of joint range of motion, lumbar myelopathy, fracture, instability). 2) Patients with history of previous lumbar surgery, gross neurological deficits and inflammatory arthritis. 3) Patients with medical red flags as severe psychiatric disorder or cognitive deficits. 4) Medically unstable and uncooperative patients. 5) Causes of hyper cortisolism other than radiculopathy as diabetes, chronic renal failure, pituitary or adrenal gland tumor. Adult: 19 Year-44 Year 30 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
Yes 21/06/2022 Research Ethical committee at faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
11 ahmed El-Zayat St,bein al sarayat, Dokki,Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measurement of serum cortisol level was done for each patient by using immulite ® 2000 systems analyzers. Measurement of pro inflammatory cytokines level was done for each patient by using Stat Fax 2100 Microplate Reader device. The patients were assessed pre and post treatment.
Secondary Outcome Pain intensity Pain was assessed by using a visual analog scale (VAS).Functional ability was evaluated by Modified Oswestry Low Back Disability Questionnaire pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic and Isokinetic lab Faculty of physical therapy Cairo University 11 ahmed El-Zayat St , Bein El sarayat, Dokki,Giza Giza 12612 Egypt
Al Kasr El Aini Hospital Cairo University Al Kasr Al Aini St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy 11 Ahmed El-Zayat St - bein elsarayat- dokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy 11 Ahmed el zayat st. Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Darwesh ashraf.darwesh@cu.edu.eg +201111462073 11 Ahmed El-Zayat St.Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Assistant professor in the department of physical therapy for Neuromuscular disorders and its surgery
Role Name Email Phone Street address
Scientific Enquiries amira bahlol ptamirabahlol@gmail.com +201009193018 elmahalla elkubra
City Postal code Country Position/Affiliation
Gharbia Egypt physiotherapist at mahalla general hospital
Role Name Email Phone Street address
Public Enquiries shereen Mohamed shereensaadeldin@hotmail.com +201009288931 11 Ahmed El-zayat St.Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer at the neurological department Faculty of physical therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data (IPD) collected during the trial ,After deidentification will be shared for research purposes only Informed Consent Form data requests can be submitted starting 9 months after article publication and the data will be made accessible for up 24 months. only researchers in the project can see 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