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Protocol summary
A single blinded randomised controlled trial, conducted on 64 patients, equally divided into two groups, single centered study
A single blinded randomised controlled trial, conducted on 60 patients, equally divided into two groups, single centered study
A single blinded randomised controlled trial, conducted on 6460 patients, equally divided into two groups, single centered study
General information
1
1
1
1
empty
There were few typing and conceptual mistakes and synopsis was updated a bit with advise of supervisor
There were few typing and conceptual mistakes and synopsis was updated a bit with advise of supervisor
All random numbers will be enclosed in sealed envelopes. A third person (who will further not be the part of research) will open envelops and the patients will be allocated to the mentioned group accordingly. In this way the patient will get blinded to the allocated treatment group.
An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients
All random numbersAn independent assessor, who will be enclosed in sealed envelopes. A third person (whoa senior and experienced physiotherapist and further will further not be the part of research)study will open envelops andperform the assessment of patients will be allocated to the mentioned group accordingly. In this way the patient will get blinded to the allocated treatment group.
Primary outcomes
#1
Inclinometer
Clinical Test (Modified-Modified Schober's Test)
InclinometerClinical Test (Modified-Modified Schober's Test)
Intervention groups
#1
Control group: The control group will receive conventional physiotherapy including electrotherapy and general exercise. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) General exercise aimed at increasing the patient’s level of physical activity (including simple exercises such as short walks, stretching and strengthening of the major muscle groups, such as gluteus and rectus abdominis)
Control group: The control group will receive conventional physiotherapy including electrotherapy and trunk stability exercises. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) Trunk stability Exercises
Control group: The control group will receive conventional physiotherapy including electrotherapy and general exercisetrunk stability exercises. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) General exercise aimed at increasing the patient’s level of physical activity (including simple exercises such as short walks, stretching and strengthening of the major muscle groups, such as gluteus and rectus abdominis)Trunk stability Exercises
Protocol summary
Study aim
To compare the effects of non-surgical spinal decompression therapy in addition to routine physical therapy in patients with lumber radiculopathy.
Design
A single blinded randomised controlled trial, conducted on 60 patients, equally divided into two groups, single centered study
Settings and conduct
Pain Center, single blinded study (patient will be blinded to the recruited group)
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Both male and female patients, Age between 25-55 years, Clinically and radiologically diagnosed patients (by neuro-surgeon) of lumbar radiculopathy, Unilateral radiating low back pain (LBP) for at least 3 months, Willing to participate in the study
Exclusion Criteria
Recent fracture or dislocation of lumber vertebra, History of surgery on lumber spine, hip or pelvis, Spinal tumors or infections in the intervertebral disc, Inflammatory diseases such as rheumatism, Spinal deformity such as scoliosis, Spondylolysthesis, Osteoporosis below first lumber vertebra (L1), Patients taking medications e.g Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for pain, Severe disc degeneration, Pregnant females, Having three or more herniation
Intervention groups
60 patients will be randomly divided into control and experimental groups. The control group will receive routine physical therapy while the experimental group will receive spinal decompression therapy alongwith the routine physical therapy.
Main outcome variables
1. Pain intensity
2. Level of disability
3. Quality of life
4. lumber Range of motion
5. Endurance
General information
Reason for update
There were few typing and conceptual mistakes and synopsis was updated a bit with advise of supervisor
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20190717044238N1
Registration date:2019-12-23, 1398/10/02
Registration timing:prospective
Last update:2021-03-25, 1400/01/05
Update count:2
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-01-10, 2018/10/20
Expected recruitment end date
2641-06-10, 2020/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial
Public title
The effects of non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients
Age between 25-55 years
Clinically and radiologically diagnosed patients (by neuro-surgeon) of lumbar radiculopathy
Radiating Low Back Pain for at least 3 months
Willing to participate in the study
Exclusion criteria:
Recent fracture or dislocation of lumber vertebra
History of surgery on lumber spine, hip or pelvis
Spinal tumors or infections in the intervertebral disc
Inflammatory diseases such as rheumatism
Spinal deformity such as scoliosis
Spondylolysthesis
Osteoporosis below L1
Patients taking medications e.g NSAIDS for pain
Severe disc degeneration
Pregnant females
Having three or more herniation
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By using computer generated random number table, patients will be randomly assigned into two groups. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be the part of research) will open envelops and the patients will be allocated to the mentioned group accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board
Street address
The University of Lahore,Pakistan
City
Lahore
Postal code
54000
Approval date
2639-12-11, 2018/09/20
Ethics committee reference number
IRB-UOL-FAHS/373-X/2018
Health conditions studied
1
Description of health condition studied
Lumber Radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
Pain Intensity
Timepoint
before intervention and after 4 weeks of intervention
Method of measurement
Visual Analogue Scale
2
Description
Lumber range of motion
Timepoint
before intervention and after 4 weeks of intervention
Method of measurement
Clinical Test (Modified-Modified Schober's Test)
Secondary outcomes
1
Description
Quality of Life
Timepoint
before intervention and after 4 weeks of intervention
Method of measurement
SF 36 scoring calculator will be used
2
Description
Level of disability
Timepoint
before intervention and after 4 weeks of intervention
Method of measurement
ODI scoring calculator
3
Description
Endurance
Timepoint
before intervention and after 4 weeks of intervention
Method of measurement
Stop Watch will be used to calculate the endurance time
Intervention groups
1
Description
Control group: The control group will receive conventional physiotherapy including electrotherapy and trunk stability exercises. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) Trunk stability Exercises
Category
Treatment - Other
2
Description
Intervention group: In addition to the interventions given in control group, participants in the experimental group will also receive spinal decompression therapy. The treatment session of 20 minutes will be given three days a week, for a total of 4 weeks. For non-surgical spinal decompression therapy of lumbar spine, the patient will be in supine lying position on a motorized table, which has movable lower half. A harness is placed around the hips and is attached to the lower table near the feet. The upper part of the table remains in a fixed position while the lower part, to which the patient is harnessed, slides back and forth to provide the traction and relaxation. Decompression isolates the distraction forces to a specific motor unit of the spine and affects a specific disc level.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Pain Center
Full name of responsible person
Fareeha Amjad
Street address
The University of Lahore,Pakistan
City
Lahore
Postal code
54000
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Web page address
https://pk.enrollbusiness.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Fareeha Amjad
Street address
The University of Lahore,Pakistan
City
Lahore
Postal code
54000
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Web page address
https://www.uol.edu.pk
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
Public
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
Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore,Pakistan
City
Lahore
Province
Pakistan
Postal code
54000
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Web page address
https://www.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore,Pakistan
City
Lahore
Province
Pakistan
Postal code
54000
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Web page address
https://www.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore,Pakistan
City
Lahore
Province
Pakistan
Postal code
54000
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Web page address
https://www.uol.edu.pk
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
All collected identified IPD
When the data will become available and for how long
Data will be available after the completion of study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator "Fareeha Amjad" on email address: fari_fairy22@yahoo.com
From where data/document is obtainable
Fareeha Amjad, fari_fairy22@yahoo.com
What processes are involved for a request to access data/document
Data/document can be accessed through communicating with principle investigator "Fareeha Amjad" on institutional email address: fari_fairy22@yahoo.com