Spinal Decompression Therapy in Radicular Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT04701879|
Recruitment Status : Completed
First Posted : January 8, 2021
Last Update Posted : September 5, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Radiculopathy Lumbar||Other: Spine decompression with core stability exercises Other: Spine decompression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Spinal Decompression Therapy With Core Stability Exercises in Radicular Chronic Low Back Pain|
|Actual Study Start Date :||November 15, 2018|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||February 28, 2021|
Active Comparator: Spine decompression with core stability exercises
Interventions in experimental group includes Hot pack, Spinal decompression therapy and core stability exercises
Other: Spine decompression with core stability exercises
Experimental: Spine decompression
Intervention includesHot pack and spinal decompression therapy ..
Other: Spine decompression
40 minutes per session
-Decompression therapy on alternate days for 8 visits.
- The Oswestry Disability Index (ODI) [ Time Frame: 0 Day ]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) [ Time Frame: 4th Day ]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) [ Time Frame: 8th Day ]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.
- Numeric pain rating scale [ Time Frame: 0 day, 4th day, 8th day ]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.
- Plank test [ Time Frame: 0 day, 4th day, 8th day ]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.
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|Ages Eligible for Study:||20 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Radicular low back pain with minimum 3 months of duration
- Both gender ( male and female)
- Age 20-60 years
- Limited Straight Leg Raise.
- With marked bony and soft tissue disease.
- Less than 20 and more than 60 years of age.
- Patients who don't have MRI reports
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701879
|Aqua research Center|
|Islamabad, Federal, Pakistan, 44000|
|Principal Investigator:||Dr M.Umer Iqbal, MS||Shifa Tameer e milat University|
|Responsible Party:||Mir Arif Hussain, Assistant professor, Aqua Medical Services (Pvt) Ltd|
|Other Study ID Numbers:||
|First Posted:||January 8, 2021 Key Record Dates|
|Last Update Posted:||September 5, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Core stability exercises
Low Back Pain
Peripheral Nervous System Diseases
Nervous System Diseases