Compare the Effects of Decompression on Lumber Disc Protrusion Patient
Primary Purpose
Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physiotherapy
Lumber Spinal Decompression
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Decompression, Disc herniation, ODI, LBP
Eligibility Criteria
Inclusion Criteria:
- MRI of lumbar spine showing lumbar disc bulge
- Localized and radiating pain more than 5 on NPRS
Exclusion Criteria
- Lumbar spondylolisthesis
- Spinal stenosis
- Fracture of lumbar spine
- Spinal tumor
- Ankylosing spondylitis
- Patients taking blood thinner medication
Sites / Locations
- Abdul Ghaffor Sajjad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Physiotherapy
Lumber spinal decompression
Arm Description
It includes the pre-physiotherapy session by conventional physiotherapy
It includes the pre-physiotherapy session iby lumber spinal decompression along with conventional therapy.
Outcomes
Primary Outcome Measures
Numeric pain rating scale for back
It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient
Flexion Range of Motion of lumber
Double inclinometer is used
SLR
Single Inclinometer
Side bending Lumber ROm
Double inclinometer
Extension Lumber ROM
Double inclinometer is used
Secondary Outcome Measures
Full Information
NCT ID
NCT04860609
First Posted
April 21, 2021
Last Updated
September 2, 2021
Sponsor
Aqua Medical Services (Pvt) Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04860609
Brief Title
Compare the Effects of Decompression on Lumber Disc Protrusion Patient
Official Title
Compare the Effect of Spinal Decompression in Lumber Spine Disc Protrusion Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aqua Medical Services (Pvt) Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria. The sampling technique is convenient sampling . The study compare the effects of conventional Physical Therapy and Decompression Therapy and determine the effectiveness of Decompression as treatment procedure for patients with Lumbar disc protrusion. The data collection procedure included the NPRS, ODI, structural questionnaire and assesment on the 1st, 4th and 8th visit. Data will be analyzed on IBM SPSS-21 {Statistical Procedure of Social Sciences} software. The assessment will be done on 1st, 4th and 8th visits. after checking the normality of the date the Parametric/Non Parametric test will be apply to compare the means of the these groups. The 95% confidence interval will be used in term OD p value 0.05
Detailed Description
Low back pain is the common problem of our society, 80% people experience back pain at some stage of their life. Low Back pain life time prevalence is 65% to 80% and It is estimated that 28% experience disabling low back pain sometime during their lives.Point prevalence ranged from 12% to 33%, 1-year prevalence ranged from 22% to 65%, and lifetime prevalence ranged from 11% to 84%.Back pain peak prevalence age is 40-50, First episode of start in the 20's and recurrence rates between 39-71%. Women tend to be affected more in cervical spine problem then men and Men tend to more affected in lumbar spine problem than women. Majority (80-90%) of low back disorders occur at the L4/5 and/or L5/S1. The occupational risk factor include driving (P<0.001), lifting, carrying, pulling, pushing, and twisting (P<0.001 for all variables) as well as nondriving vibrational exposure (P<0.001).
Maitland divides lumber spine problems into two groups, in first group the L4/5 and L5/S1 intervertebral discs are frequently a source of symptoms and second group have postural, muscles balance, muscles weakness, muscles spasm degenerative changes and mechanical movement disorders problems. The L5-S1 Segment is the most common site of problem in the spine because this level bears more weight, Center of gravity passes directly through this vertebra, transition L5 Mobile and S1 Stable, Large angle B/w L5 & S1 and great amount of movement.
The intervertebral disk makes up 1/3 of the total length of vertebral column. The disc contains 85% to 90% of water, but the amount decrease up to 65% with age. The water binding capacity of the disc decrease with age and degenerative changes begin to occur after 2nd decade of the life. The Facet joint carry 20-25% axial body load but this may reach 70% with degeneration of the Disc. The most significant biochemical change to occur in disc degeneration is loss of proteoglycan. This loss is responsible for a fall in the osmotic pressure of the disc matrix and therefore a loss of hydration. Loading may thus lead to inappropriate stress concentrations along the endplate or in the annulus.
Decompression therapy is a result oriented approach but it expensive and minimum availability in Pakistan. In physical therapy we use different exercise to solve the multiple spine problems. Some exercise used to treat orthopedic component such as mobilization, manipulation, SNAGS, and traction. Some exercise used to treat myogenic component such as Muscle energy technique, neuromuscular reeducation, active isolated stretch etc. Some exercise used to treat neurogenic component such as Neurodynamics, Active release technique etc. As we know the fascia is important component in our body most of the time the fascia restriction make the patient condition verse. Guy Voyer introduce the systems of exercise more the 35 years ago which works specially on spine at every intervertebral level including costal and pelvic articulation. These exercises are called Elongation Longitudinaux avec Decoaption Osteo-Articulaire (ELDOA) or simply Longitudinal Osteo-Articular De-coaptation Stretching (LOADS). It can be describe as fascial stretch that's localizes tension at the level of a specific spinal segment and create decompression. In which he combined improving the tone of the intrinsic muscles of the spine along with reinforcing the extrinsic muscles related to the spine aim the back and stretching the interlinking paraspinal muscles. ELDOA exercise is design for every level of the spine from base of the skull to sacro iliac joint. In each ELDOA exercise we create fascial tension above and below the joint or disc that one is trying to "open up" or decompress. The outcomes include; Release vertebral compression, improved blood circulation, Disc re-hydration, improve muscle tone and awareness. One of my study also proved that ELDOA Exercises improve the pain and functional level in the spinal disc protrusion patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Decompression, Disc herniation, ODI, LBP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control group will recevie conventional physiotherapy sessions while the experimental group receive conventional along with decompression
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
It includes the pre-physiotherapy session by conventional physiotherapy
Arm Title
Lumber spinal decompression
Arm Type
Experimental
Arm Description
It includes the pre-physiotherapy session iby lumber spinal decompression along with conventional therapy.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
The treatment will be given in the following way.
Tens
Infrared/Moist Heat heat for 10 minutes at low back region.
Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
Postural Education
Home Plan
Bed Rest with lumbar Sacral Support
Home plan:
Exercises Posture Correction Precautions Contra indication
Intervention Type
Other
Intervention Name(s)
Lumber Spinal Decompression
Intervention Description
The treatment will be given in the following way.
Tens
Infrared/Moist Heat heat for 10 minutes at low back region.
Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
Postural Education
Home Plan
Decompression therapy session lumbar spinal decompression therapy for 30 minutes.
Home plan:
Exercises Posture Correction Precautions Contra indication
Primary Outcome Measure Information:
Title
Numeric pain rating scale for back
Description
It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient
Time Frame
8th weeks
Title
Flexion Range of Motion of lumber
Description
Double inclinometer is used
Time Frame
8th weeks
Title
SLR
Description
Single Inclinometer
Time Frame
8th weeks
Title
Side bending Lumber ROm
Description
Double inclinometer
Time Frame
8th week
Title
Extension Lumber ROM
Description
Double inclinometer is used
Time Frame
8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MRI of lumbar spine showing lumbar disc bulge
Localized and radiating pain more than 5 on NPRS
Exclusion Criteria
Lumbar spondylolisthesis
Spinal stenosis
Fracture of lumbar spine
Spinal tumor
Ankylosing spondylitis
Patients taking blood thinner medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghaffor Sajjad, PhD
Organizational Affiliation
Shifa tameer-e-millat university Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abdul Ghaffor Sajjad
City
Islamabad
State/Province
Capital
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Compare the Effects of Decompression on Lumber Disc Protrusion Patient
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