To determine the effect of graston instrument soft tissue mobilization in patients with sciatic nerve entrapment.
Design
Randomized Clinical Trial
Settings and conduct
Fatima Memorial Hospital Shadman Lahore.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Onset of radicular low back pain of less than 12 weeks.
2. Pain upon active SLR in 30-70̊. Sensitivity: 0.67 (11) Specificity: 0.26 (12)
3. Age group in range of 30-60 years.
4. Male only.
5. Sciatic nerve entrapment diagnosed on MRI
Exclusion Criteria
1. Spinal Fracture.
2. Spinal tumor or any malignancy.
3. Psychiatric Disorder.
4. History of Osteoporosis.
5. Rheumatologic disorders.
6. Pain beyond 70̊ or below 30̊ on active SLR.
7. Positive compression and distraction test of SI joint.
8. Positive gaenslen’s test.
9. Any red flags.
Intervention groups
Group A: Participants will receive graston instrument soft tissue mobilization.
Group B: Participants will receive combine treatment of graston instrument technique with lumbar traction and neural mobilization.
EFFECTS OF GRASTON INSTRUMENT SOFT TISSUE MOBILIZATION IN PATIENTS WITH SCIATIC NERVE ENTRAPMENT
Public title
EFFECTS OF GRASTON INSTRUMENT SOFT TISSUE MOBILIZATION IN PATIENTS WITH SCIATIC NERVE ENTRAPMENT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Onset of radicular low back pain of less than 12 weeks.
Pain upon active SLR in 30-70̊. Sensitivity: 0.67(11) Specificity: 0.26 (12)
Age group in range of 30-60 years.
Male only.
Sciatic nerve entrapment diagnosed on MRI.
Exclusion criteria:
Spinal Fracture.
Spinal tumor or any malignancy.
Psychiatric Disorder.
History of Osteoporosis.
Rheumatologic disorders.
Pain beyond 70̊ or below 30̊ on active SLR.
Positive compression and distraction test of SI joint.
Positive gaenslen’s test
Any red flags.
Age
From 30 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Patient will be recruited into Group A and Group B by lottery method (without replacement).
Blinding (investigator's opinion)
Single blinded
Blinding description
Single Blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah College of Rehabilitation and Allied Health Sciences
Street address
13-14-C-Civic centre , Near Hamdard Chowk, Township Lahore
City
Lahore
Postal code
54000
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
RCR&AHS/REC/MS-OMPT/S19/004
Health conditions studied
1
Description of health condition studied
Sciatic Nerve Entrapment
ICD-10 code
M54.30
ICD-10 code description
Sciatica, unspecified side
Primary outcomes
1
Description
Pain
Timepoint
Treatment will be given to both groups for 4 weeks, 3 sessions per week and post treatment evaluation will be done after two weeks and follow up evaluation after one month by NPRS.
Method of measurement
Numeric Pain Rating Scale
2
Description
Functional Disability
Timepoint
Treatment will be given to both groups for 4 weeks, 3 sessions per week and post treatment evaluation will be done after two weeks and follow up evaluation after one month by MODI.
Method of measurement
Modified Oswestry Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Graston technique with help of graston instrument is applied (3 sessions per week for 4 weeks)
Category
Treatment - Other
2
Description
Intervention group B: Graston technique along with lumber traction (Mechanical) and neural mobilization. (3 sessions per week for 4 weeks)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Memorial Hospital Shadman Lahore
Full name of responsible person
Dr Farhia Shah
Street address
Shadman Rd, Ichhra Lahore, Punjab 54000
City
Lahore
Postal code
54000
Phone
+92 42 35940444
Email
farhia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University QIE Campus
Full name of responsible person
Dr Syed Shakeel ur Rehman
Street address
13-14-C-Civic Centre, Near Hamdard Chowk,Township Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Fax
Email
shakil.urrehman@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University QIE Campus
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University QIE Campus
Full name of responsible person
Muhammad Shahzad Qadree
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Centre Near Hamdard Chowk Township Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
shhzdqadree@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University QIE Campus
Full name of responsible person
Prof. Dr. Syed Shakeel ur Rehman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Centre Near Hamdard Chowk Township Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
shakil.urrehman@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University QIE Campus
Full name of responsible person
Muhammad Shahzad Qadree
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Centre Near Hamdard Chowk Township Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 302 8350237
Email
shhzdqadree@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available