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.: PACTR201901663419409 Date of Approval: 29/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of Shockwave Therapy Combined with Neural Mobilization on Adolescents with Idiopathic Scoliosis
Official scientific title The Effects of Shockwave Therapy Combined with Neural Mobilization on Adolescents with Idiopathic Scoliosis
Brief summary describing the background and objectives of the trial BACKGROUND: The development and progression of Adolescent idiopathic scoliosis (AIS)are proposed to result from vertebral column overgrowth through a lordoscoliotic maladaptation of the spine to the subclinical tether of a relatively short spinal cord. conservative management of scoliosis became a timely and interesting topic in the field of physical therapy and health services. That¿s why the application of extracorporeal shockwave therapy(ESWT)has become a subject of growing interest and its importance in the treatment of spine pathology e.g. adolescent idiopathic scoliosis has become increasingly recognized. OBJECTIVES: This study will be conducted to investigate and compare the effect of neural mobilization program, ESWT and neural mobilization added ESWT in the treatment of patients with AIS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial shockwave and neural mobilization
Anticipated trial start date 01/07/2019
Actual trial start date
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional physical therapy program in addition shockwave therapy The whole program will be applied two sessions/ week for twelve consecutive weeks. conventional physical therapy program will include: (infrared radiation and FITS method as physiotherapeutic scoliosis-specific exercises). infrared radiation for 15 minutes at a distance of 50 cm from the back region for warming up. FITS method will be performed as an outpatient program two times a week for 45 minutes for all groups. In this study, extracorporeal shockwave therapy will be applied to the group (A) and (C) only with a total number of eight sessions (one session every ten days for twelve consecutive weeks All patients in the three groups will receive the treatment program for twelve consecutive weeks All groups will receive infrared radiation for 15 minutes at a distance of 50 cm from the back region for warming up. b)The exercise mechanics of FITS are as follows: 1. Sensory-motor balance training to improve nervous system control over the muscle’s function. 2. Mobilization and myofascial techniques to eliminate myofascial restrictions which limit three-plane corrective movement. 3. 3D correction breathing to increase derotation movement and improve breathing mechanism. 4. Corrective patterns – active correction. 5. Neuromuscular Re-education. 6. Auto-correction in activities of daily living (Berdishevsky et al., 2016). c) Application procedures for extracorporeal shockwave therapy: a) The patient will be in an inclined prone kneeling with the shoulders flexed and abducted and the head rested on the hands or on the plinth (Weiss, 2017). b) Treatment will be directly paravertebral on both sides of the vertebral column (never directly on the spinous processes). c) The apical area of scoliosis is the focus of treatment (mainly on the concave side) and the orientation of application will be in the cranial direction. d) The researcher will apply ultrasonic gel to the treatment area 20 Active-Treatment of Control Group
Experimental Group conventional physical therapy program in addition to neural mobilization and shockwave therapy The whole program will be applied two sessions/ week for twelve consecutive weeks. conventional physical therapy program will include: (infrared radiation and FITS method as physiotherapeutic scoliosis-specific exercises). infrared radiation for 15 minutes at a distance of 50 cm from the back region for warming up. FITS method will be performed as an outpatient program two times a week for 45 minutes for all groups. In this group, extracorporeal shockwave therapy will be applied for the group (C) with a total number of eight sessions (one session every ten days for twelve consecutive weeks neural mobilization technique in slump-sitting will be applied for the group (C) The stretch force for this technique is held for 15 to 20 seconds, released, and then repeated several times. All patients in the three groups will receive the treatment program for twelve consecutive weeks a) Infrared radiation: All groups will receive infrared radiation for 15 minutes at a distance of 50 cm from the back region for warming up. b)The exercise mechanics of FITS are as follows: 1. Sensory-motor balance training to improve nervous system control over the muscle’s function. 2. Mobilization and myofascial techniques to eliminate myofascial restrictions which limit three-plane corrective movement. 3. 3D correction breathing to increase derotation movement and improve breathing mechanism. 4. Corrective patterns – active correction. 5. Neuromuscular Re-education. 6. Auto-correction in activities of daily living (Berdishevsky et al., 2016). c) Application procedures for extracorporeal shockwave therapy: a) The patient will be in an inclined prone kneeling with the shoulders flexed and abducted and the head rested on the hands or on the plinth (Weiss, 2017). b) Treatment will be directly paravertebral on both sides of the vertebral column (never directly on the spinous processes). c) The apical area of scoliosis is the focus of treatment (mainly on the concave side) and the orientation of application will be in the cranial direction. d) The researcher will apply ultrasonic gel to the treatment area..). neural mobilization technique The stretch force for this technique is held for 15 to 20 seconds, released, and then repeated several times In this group, the neural mobilization technique in slump-sitting will be applied to the group (C) Patient position and procedure: - Begin with the patient sitting upright. - Have the patient slump by flexing the neck, thorax, and low back. - Apply overpressure to the cervical spine. - Dorsiflex the ankle and then extend the knee as much as possible. - Release the overpressure on the spine and have the patient actively extend the neck to see if symptoms decrease. - Increase and release the stretch force by moving one joint in the chain a few degrees, such as knee flexion and extension or ankle dorsiflexion and plantarflexio 20
Control Group neural mobilization technique and conventional physical therapy program neural mobilization technique The stretch force for this technique is held for 15 to 20 seconds, released, and then repeated several times. conventional physical therapy program:( infrared radiation and FITS method) - infrared radiation: All groups will receive infrared radiation for 15 minutes at a distance of 50 cm from the back region for warming up. - FITS method It will be performed as an outpatient program two times a week for 45 minutes for all groups. two sessions/ week for twelve consecutive weeks All patients in the three groups will undergo a conventional physical therapy program two sessions/ week for twelve consecutive weeks which includes infrared radiation and FITS method as physiotherapeutic scoliosis-specific exercises. In this study, neural mobilization technique in slump-sitting will be applied for the group (B) Patient position and procedure: - Begin with the patient sitting upright. - Have the patient slump by flexing the neck, thorax, and low back. - Apply overpressure to the cervical spine. - Dorsiflex the ankle and then extend the knee as much as possible. - Release the overpressure on the spine and have the patient actively extend the neck to see if symptoms decrease. - Increase and release the stretch force by moving one joint in the chain a few degrees, such as knee flexion and extension or ankle dorsiflexion and plantarflexion. - The stretch force for this technique is held for 15 to 20 seconds, released, and then repeated several times. - After the therapist has performed several treatments and learned the tissue response, the patient is will be taught self-stretching (Butler, 2000; Kisner and Colby, 2012). 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusive criteria: ¿ All participants¿ diagnosis is AIS. ¿ The participant's age is between 10 to 18 years. ¿ All participants have a Cobb angle from 15 to 30 degrees. ¿ All participants are not practicing any sort of physical exercise. Exclusive criteria: ¿ Participants who had previous spinal surgery. ¿ Participants who had received physical therapy program in the last three months. ¿ Participants who had a medical diagnosis other than AIS. ¿ Participants who had any other spine disorders. ¿ Participants who had leg length discrepancies. ¿ Participants with congenital postural deformities. ¿ Participants with a definitive visual disorder. ¿ Participants with spinal cord injury or acute or unstable neurological signs. ¿ Participants with cauda equina symptoms related to the spine including changes in bowel or bladder control and perineal sensation. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 18 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 06/05/2018 research ethical committee
Ethics Committee Address
Street address City Postal code Country
7 ahmed el zayat- dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Measurement of finger to floor distance (FFD): at the beginning of the treatment program and at the end of twelve consecutive weeks.
Primary Outcome 2. Measurement of Angle of trunk rotation: at the beginning of the treatment program and at the end of twelve consecutive weeks.
Secondary Outcome 3. Cobb angle measurement by X-ray: at the beginning of the treatment program and at the end of twelve consecutive weeks.
Secondary Outcome 4. the relative length of spinal cord to the vertebral column by MRI. at the beginning of the treatment program and at the end of twelve consecutive weeks.
Secondary Outcome the level of functional ability at the beginning of the treatment program and at the end of twelve consecutive weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy and rehabilitation center 6 Qena-Safaga road Qena 83523 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sallam Ali Shoura 12 Third Neighborhood, 1st District New Qena 83523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor south valley university qena Qena 83523 Egypt University
Primary Sponsor Sallam Ali Shoura 12 Third Neighborhood, 1st District New Qena 83523 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Amir Mohamed Saleh Abbas el akkad cairo 11765 Egypt
Dr. Ahmed Ebrahim Ahmed 7 Ahmed el zayat, dokki Giza 12611 Egypt
Dr. Wael Mohamed Wagdy Qena-safaga road Qena 83523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Amir Saleh amirsalehed@hotmail.com 01006668168 Abbas el akkad
City Postal code Country Position/Affiliation
cairo 11765 Egypt Professor of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries mohamed sarhan sarhanpt@svu.edu.eg 01115005202 Qena-Safaga road
City Postal code Country Position/Affiliation
qena 83523 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Principal Investigator Sallam Shoura sallampt@svu.edu.eg 01000693632 12 Third Neighborhood, 1st District
City Postal code Country Position/Affiliation
New Qena 83523 Egypt assistant lecturer of Physical Therapy south valley University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data, and measurements data Study Protocol 2 years open
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