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Effects of Low Intensity Pulsed Ultrasound on Clinical and Radiological Outcomes in Patients with Early Stage Lumbar Spondylolysis: A Randomized Controlled Trial

Protocol summary

Study aim
To compare the effect of routine physical therapy with routine physical therapy and low intensity pulsed ultrasound on clinical and radiological outcomes in patients with early stage lumbar spondylolysis.
Design
A concealed, randomized, blinded, controlled clinical trial with a parallel group design of 34 patients, enrolled between May 2020 and November 2020, and followed for one year
Settings and conduct
The list of diagnosed cases will be obtained from the department of orthopedics, patients will be randomly selected and will be approached by principal investigator after informed consent taken and their approval and ethical approval they will be included in the study. The principal investigator will be known to the type of treatment but the assessor here will be kept blinded by labeling treatment A and treatment B to either group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age: 20-40 years, Both Gender, Married living with their spouse as Oswestry Low Back Pain Disability Questionnaire is consisted of a part based on sexual activity, Diagnosed cases of early stage spondylolysis on x-ray and Symptomatic low-back pain since more than 4 weeks. Exclusion Criteria: History of neurological or autonomic deficits, History of other fracture or bony abnormalities, History of rheumatic disease, History of other spinal problems, History of post-menopausal female, History of osteoporosis, History of osteopenia
Intervention groups
Group A: will receive the routine physical therapy alone. Group B: will receive the routine physical therapy and low intensity pulsed ultrasound.
Main outcome variables
Pain, Quality of Life, Muscle Strength, Functional Disability and X-ray findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200206046396N1
Registration date: 2020-05-02, 1399/02/13
Registration timing: prospective

Last update: 2020-05-02, 1399/02/13
Update count: 0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Fahad Tanveer
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 35184348
Email address
fahadtanveer3.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-15, 1399/02/26
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Low Intensity Pulsed Ultrasound on Clinical and Radiological Outcomes in Patients with Early Stage Lumbar Spondylolysis: A Randomized Controlled Trial
Public title
Effects of Low Intensity Pulsed Ultrasound on Clinical and Radiological Outcomes in Patients with Early Stage Lumbar Spondylolysis: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 20-40 years Both Gender Married living with their spouse as Oswestry Low Back Pain Disability Questionnaire is consisted of a part based on sexual activity Diagnosed cases of early stage spondylolysis on x-ray Symptomatic low-back pain since more than 4 weeks
Exclusion criteria:
History of neurological or autonomic deficits History of other fracture or bony abnormalities History of rheumatic disease History of other spinal problems History of post-menopausal female History of osteoporosis History of osteopenia
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blind as the treatment groups will be named as group A or group B. Assessor will not aware about group A and group B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board of University Institute of Physical Therapy, The University of Lahore
Street address
1 Km Off Raiwind Road, Lahore
City
Lahore
Postal code
54792
Approval date
2020-01-22, 1398/11/02
Ethics committee reference number
IRB-UOL-FAHS/690/2020

Health conditions studied

1

Description of health condition studied
Early Stage Lumbar Spondylolysis
ICD-10 code
M43.06
ICD-10 code description
Spondylolysis, lumbar region

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and 8, 20 weeks after intervention
Method of measurement
Numeric Pain Rating Scale

2

Description
Quality of Life
Timepoint
Before intervention and 8, 20 weeks after intervention
Method of measurement
World Health Organization Quality of Life-Bref

3

Description
Functional Disability
Timepoint
Before intervention and 8, 20 weeks after intervention
Method of measurement
Oswerty Disability Index

4

Description
Muscle Strength
Timepoint
Before intervention and 8, 20 weeks after intervention
Method of measurement
Hand Held Dynamometry

5

Description
Radiological Union
Timepoint
Before intervention and 8, 20 weeks after intervention
Method of measurement
X-ray

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group– will get Routine Physical Therapy + Low Intensity Pulsed Ultrasound 60 minutes of session, Alternative three days/ week for 12 weeks.
Category
Treatment - Other

2

Description
Control Group– will get Routine Physical Therapy 40 minutes of session, Alternative three days/ week for 12 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Orthopedic Surgery, University of Lahore Teaching Hospital, Lahore.
Full name of responsible person
Dr. Imran Salim Malik
Street address
1 Km off Defense Road, Lahore
City
Lahore
Postal code
74000
Phone
+92 42 37553435
Email
imransmalik@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof Dr Ashfaq Ahmad
Street address
1 Km Off Raiwind Road, Lahore
City
Lahore
Postal code
54792
Phone
+92 42 35322501
Email
ashfaaqpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
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
The University of Lahore
Full name of responsible person
Fahad Tanveer
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 Km Off Raiwind Road, Lahore
City
Lahore
Province
Punjab
Postal code
54792
Phone
+92 42 35184348
Email
fahadtanveer3.pt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Fahad Tanveer
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 Km Off Raiwind Road, Lahore
City
Lahore
Province
Punjab
Postal code
54792
Phone
009235184348
Email
fahadtanveer3.pt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University pf Lahore
Full name of responsible person
Fahad Tanveer
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 Km Off Raiwind Road, Lahore
City
Lahore
Province
Punjab
Postal code
54792
Phone
+92 42 35184348
Email
fahadtanveer3.pt@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
after publication of the study
To whom data/document is available
people working in academic institutions and researchers
Under which criteria data/document could be used
on informed request from the investigator
From where data/document is obtainable
via email / telephonic contact with investigator
What processes are involved for a request to access data/document
on email request data will be provided within week
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