The aim of this study to see the effect of radial extracorporeal shock wave therapy for sciatic pain with herniation
Improve patients quality of life
Design
randomized clinical trails, parallel group single blinded with sample of 28 patients taking from single center
Settings and conduct
Data will be conducted from OPD of Physiotherapy department of Madinah Teaching Hospital.
in this study patient will be blinded to their treatment
Participants/Inclusion and exclusion criteria
Patients of 30-45 years of age having moderate to sever low back and buttock pain runs down to the leg and have positive straight leg raising test and slump test and Patients have numbness or weakness and feeling of pins and needles in lower back, buttock, legs or feet and chronic condition last one to three months are included in the study
Patients with acute pain, Spinal fractures, Previous history of any inflammatory disease, Presence of any implant, Pregnancy, Any malignant condition, Epiphyseal plate in the area, fixed contractures in lower limb, phobia from shockwaves, Any perceptive and cognitive disorders and Uncooperative patients are excluded from the study
Intervention groups
total 28 patients are included in the study which are equally divided into two group 14 patients in treatment group (A) that receives baseline treatment including moist hot packs and mechanical traction for 10 minutes and then perform McKenzie exercises and then apply radial extracorporeal shockwave with frequency of 5HZ and 1000 shocks/session, three sessions per week for one month and 14 patients in control group (B) that receives baseline treatment including moist hot packs for 10 minutes, mechanical traction for 10 minutes then do McKenzie exercises (extension approach) without application of shockwave therapy
Main outcome variables
pain,
functional improvement
General information
Reason for update
Acronym
rESWT trial
IRCT registration information
IRCT registration number:IRCT20210112050014N1
Registration date:2021-04-10, 1400/01/21
Registration timing:registered_while_recruiting
Last update:2021-04-10, 1400/01/21
Update count:0
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Rafia Bibi
Name of organization / entity
The University Of Faisalabad
Country
Pakistan
Phone
+92 41 8868326
Email address
dpt-fa11-067@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-15, 1399/11/27
Expected recruitment end date
2021-05-15, 1400/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of radial extracorporeal shockwave therapy for sciatic pain with disc herniation
Public title
Effect of radial extracorporeal shockwave therapy for sciatic pain with disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both males and females between the age of 30-45 years having low back pain
patient with moderate to severe low back and buttock pain runs down to the leg and having positive straight leg raising test between the angle of 30 to 70 degree
patients have numbness and weakness and feeling of pins and needles in affected leg and feet
pain that worsen with movement
chronic sciatic pain lasts for 1 to 3 months
psychological stable patients
Exclusion criteria:
acute pain
bilateral sciatica
spinal fractures
pregnancy
previous history of any inflammatory disease
presence of any implant
epiphyseal plate in the area
any malignant condition
patients with fixed contractures in the lower limb
patients having phobia with shockwaves
Age
From 30 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done through the computer generated system on openEpi website for sample size calculation
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study patient will be blind. He/ she is not the one who will choose the treatment by themselves voluntarily. Treatment option will be written on two chits and patient will select one treatment chit.
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of The University Of Faisalabad
Street address
Sargodha Road, University Town, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2021-01-28, 1399/11/09
Ethics committee reference number
TUF/Dean/2021/06
Health conditions studied
1
Description of health condition studied
sciatic pain resulting from disc herniation
ICD-10 code
M54.30
ICD-10 code description
Sciatica, unspecified side
Primary outcomes
1
Description
pain
Timepoint
Pain will be measured at the time of initial assessment, then after two weeks and after fourth week
Method of measurement
Visual analogue scale consist of 0 to 10 numbering for measurement of pain intensity ask patients to select any number from 0 to 10
Secondary outcomes
1
Description
disability
Timepoint
Questioner will be used at the time of assessment then after two weeks and after fourth week
Method of measurement
The patient is instructed to put a mark next to each appropriate statement, at the beginning of treatment, a patient’s score was 12 and, at the conclusion of treatment, her score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
Intervention groups
1
Description
treatment group (A) receive baseline treatment include moist hot packs for 10 minutes at lower back then apply mechanical traction for 10 minutes then do shockwave therapy at paravertebral area of L4, L5 and S1 with frequency of 5 HZ and 1000 shocks/session then do McKenzie exercise (extension approach). total 3 sessions will be perform once a week for 4 weeks
Category
Rehabilitation
2
Description
Control group (B) receive baseline treatment includes moist hot pack for 10 minutes then apply mechanical traction for 10 minutes then do McKenzie exercises (extension approach) and shockwave therapy will not apply in control group. Total three sessions will perform per week for 4 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Dr. Rafia BiBi, PT
Street address
Sargodha Road, University Town, Faisalabad, Punjab