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Spinal Decompression Therapy in Radicular Chronic Low Back Pain

Primary Purpose

Radiculopathy Lumbar

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Spine decompression with core stability exercises
Spine decompression
Sponsored by
Aqua Medical Services (Pvt) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy Lumbar focused on measuring Physical therapy, Spinal decompression, Core stability exercises, Radiculopathy Lumbar

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Radicular low back pain with minimum 3 months of duration
  • Both gender ( male and female)
  • Age 20-60 years
  • Limited Straight Leg Raise.

Exclusion Criteria:

  • With marked bony and soft tissue disease.
  • Less than 20 and more than 60 years of age.
  • Patients who don't have MRI reports

Sites / Locations

  • Aqua research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spine decompression with core stability exercises

Spine decompression

Arm Description

Interventions in experimental group includes Hot pack, Spinal decompression therapy and core stability exercises

Intervention includesHot pack and spinal decompression therapy ..

Outcomes

Primary Outcome Measures

The Oswestry Disability Index (ODI)
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
The Oswestry Disability Index (ODI)
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
The Oswestry Disability Index (ODI)
The most reliable tool used by clinicians to determine the functional disability of patients. Nowadays, the gold standard tool used for the functional outcomes of the lower back is ODI.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
September 2, 2021
Sponsor
Aqua Medical Services (Pvt) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04701879
Brief Title
Spinal Decompression Therapy in Radicular Chronic Low Back Pain
Official Title
Effect of Spinal Decompression Therapy With Core Stability Exercises in Radicular Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 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
The study design was randomized control trial and sampling technique was lottery method. After inclusion and exclusion criteria, sample populations were divided into experimental (group A) and control group (group B). Spinal decompression therapy in combination with core stability exercises were given to experimental group as intervention while spinal decompression therapy given alone to the control group. Assessment was taken on after 1st session, 4th session and 8th session of physical therapy intervention. Data were entered and analyzed by SPSS version 21.
Detailed Description
Lower back pain is a common disorder that include any discomfort in the lumbar area below the origin of ribs and above the area of buttocks.Lower back pain with disability is 2nd most often reason for the wastage of time & money.Almost all people suffer from lower back pain at some age of their life .Both genders are effected equally by low back pain. The common problem of lower back pain are when you lift a heavy object prolonged unsupported sitting, accidents, sedentary life style. Sedentary life style could be the cause of low back pain usually when strenuous workout done on weekends as compared to minimal activities on week days. Lumbar area of the back hold and support the weight of the upper body and body do twisting and bending at this area. Specific or non-specific lower back pain is the classifications. Pain caused by any deformity, injury or any physical activity is called non-specific lower back pain.Non-specific lower back pain cannot be having any specific pathology, changes in behavior of movement pattern due to fear avoidance having bad postural control cause this non-specific pain.Lower back pain is one of the general health setbacks globally. It is the leading cause of people's absence from work and limits their activities.Prevalence and burden of low back pain increased with aging.Spinal decompression can create a opposite intradiscal pressure to promote led back of the herniated or bulging disc material and this oppsosity in the disc will cause influx of healing nutrients and other substances into the disc Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.A strong core is important to the healthy spine. Abdominal muscle can help the back muscle supporting supine. If core muscle are weak, supine carry extra pressure on your back muscles. For this stabilizing and core exercises are important to strengthen back spine. By increasing endurance of these muscles core muscle should be strong. Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.In 2008, a researcher found that stabilization exercises helpful in spinal rehabilitation to prevent from any sports injury. Another study by Hodges in 2003 stated that exercises for central muscle is an developing process; additional work necessary to purify and authenticate move forward, mainly with reference to understand the neurobiology of chronic pain.A study in 2011 on comparison between stabilization plan and Pilates technique for treating Low back pain. Their results showed that, Pereira technique is not is not helpful in get better back pain and function, in comparison with control and lumbar stabilization exercise groups.In exercise plan Mat and gym ball exercise for strength training and step box were used to develop an independent habit of exercise .these exercise plan intend to increase strength of muscle and decrease pain. As a main exercise walking is, safe, suitable and easy to decrease low back pain because it does not involve forceful and twisting forward flexion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy Lumbar
Keywords
Physical therapy, Spinal decompression, Core stability exercises, Radiculopathy Lumbar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spine decompression with core stability exercises
Arm Type
Active Comparator
Arm Description
Interventions in experimental group includes Hot pack, Spinal decompression therapy and core stability exercises
Arm Title
Spine decompression
Arm Type
Experimental
Arm Description
Intervention includesHot pack and spinal decompression therapy ..
Intervention Type
Other
Intervention Name(s)
Spine decompression with core stability exercises
Intervention Description
50 minutes per session Decompression with core stability on alternate days for 8 visits.
Intervention Type
Other
Intervention Name(s)
Spine decompression
Intervention Description
40 minutes per session -Decompression therapy on alternate days for 8 visits.
Primary Outcome Measure Information:
Title
The Oswestry Disability Index (ODI)
Description
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
Time Frame
0 Day
Title
The Oswestry Disability Index (ODI)
Description
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
Time Frame
4th Day
Title
The Oswestry Disability Index (ODI)
Description
The most reliable tool used by clinicians to determine the functional disability of patients. Nowadays, the gold standard tool used for the functional outcomes of the lower back is ODI.
Time Frame
8th Day
Other Pre-specified Outcome Measures:
Title
Numeric pain rating scale
Description
The NPRS is used as an alternative tool of VAS in which the subject responds to the intensity of pain from 0 to 10. The total number of NPRS is 0 to 10 from which zero is considered as no pain, one to three is considered as mild pain, four to six considered as moderate pain and seven up to 10 considered as severe pain. the patient is guided to score the intensity of pain from zero to ten by own self.
Time Frame
0 day, 4th day, 8th day
Title
Plank test
Description
The test used to assess the strength of core muscles is known as plank test. It controls the endurance of the back/core stabilizing muscles. The starting position of the participants is to support the body by their elbows and forearm when off from the ground. The patient is guided to hold this position maximally. The test will be ended if the participants are unable to hold this position and time is noted by stopwatch. Total completed time will be the score to assess the core muscle strength.
Time Frame
0 day, 4th day, 8th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Radicular low back pain with minimum 3 months of duration Both gender ( male and female) Age 20-60 years Limited Straight Leg Raise. Exclusion Criteria: With marked bony and soft tissue disease. Less than 20 and more than 60 years of age. Patients who don't have MRI reports
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr M.Umer Iqbal, MS
Organizational Affiliation
Shifa Tameer e milat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aqua research Center
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Spinal Decompression Therapy in Radicular Chronic Low Back Pain

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