Clinical trial NCT04860609: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Decompression
Disc herniation
ODI
LBP
Lead sponsor: Aqua Medical Services (Pvt) Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group will recevie conventional physiotherapy sessions while the experimental group receive conventional along with decompression
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. MRI of lumbar spine showing lumbar disc bulge
2. Localized and radiating pain more than 5 on NPRS

Exclusion Criteria

1. Lumbar spondylolisthesis
2. Spinal stenosis
3. Fracture of lumbar spine
4. Spinal tumor
5. Ankylosing spondylitis
6. Patients taking blood thinner medication

Primary outcomes:
measure: Numeric pain rating scale for back
timeFrame: 8th weeks
measure: Flexion Range of Motion of lumber
timeFrame: 8th weeks
measure: SLR
timeFrame: 8th weeks
measure: Side bending Lumber ROm
timeFrame: 8th week
measure: Extension Lumber ROM
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Abdul Ghaffor Sajjad
state: Capital
Study officials:
affiliation: Shifa tameer-e-millat university Islamabad
name: Abdul Ghaffor Sajjad, PhD
role: PRINCIPAL_INVESTIGATOR
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