Protocol summary
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Study aim
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To compare the effects of non-surgical spinal decompression therapy in addition to routine physical therapy in patients with lumber radiculopathy.
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Design
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A single blinded randomised controlled trial, conducted on 60 patients, equally divided into two groups, single centered study
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Settings and conduct
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Pain Center, single blinded study (patient will be blinded to the recruited group)
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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1. Pain intensity
2. Level of disability
3. Quality of life
4. lumber Range of motion
5. Endurance
General information
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Reason for update
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data collection has been completed
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20190717044238N1
Registration date:
2019-12-23, 1398/10/02
Registration timing:
prospective
Last update:
2021-07-06, 1400/04/15
Update count:
2
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Registration date
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2019-12-23, 1398/10/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-20, 1397/07/28
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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2020-01-01, 1398/10/11
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Actual recruitment end date
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2021-04-01, 1400/01/12
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Trial completion date
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2021-06-01, 1400/03/11
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Scientific title
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The effects of non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial
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Public title
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The effects of non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-20, 1397/06/29
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Ethics committee reference number
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IRB-UOL-FAHS/373-X/2018
Health conditions studied
1
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Description of health condition studied
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Lumber Radiculopathy
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ICD-10 code
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M54.16
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ICD-10 code description
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Radiculopathy, lumbar region
Primary outcomes
1
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Description
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Pain Intensity
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Timepoint
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before intervention and after 4 weeks of intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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Lumber range of motion
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Timepoint
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before intervention and after 4 weeks of intervention
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Method of measurement
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Clinical Test (Modified-Modified Schober's Test)
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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before intervention and after 4 weeks of intervention
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Method of measurement
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SF 36 scoring calculator will be used
2
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Description
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Level of disability
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Timepoint
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before intervention and after 4 weeks of intervention
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Method of measurement
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ODI scoring calculator
3
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Description
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Endurance
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Timepoint
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before intervention and after 4 weeks of intervention
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Method of measurement
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Stop Watch will be used to calculate the endurance time
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The University of Lahore
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected identified IPD
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When the data will become available and for how long
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Data will be available after the completion of study and will remain available till 6 months
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To whom data/document is available
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Data will be available for other people almost 6 months after the completion of study
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Under which criteria data/document could be used
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The data/document could be used by communicating with the principle investigator "Fareeha Amjad" on email address: fari_fairy22@yahoo.com
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From where data/document is obtainable
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Fareeha Amjad, fari_fairy22@yahoo.com
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What processes are involved for a request to access data/document
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Data/document can be accessed through communicating with principle investigator "Fareeha Amjad" on institutional email address: fari_fairy22@yahoo.com
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Comments
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N/A