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Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Decompression with 30%
Decompression with 40%
Decompression with 50%
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Pain, Radiculopathy, Lumbar, Decompression

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both Genders
  • Age between 30 to 50 years
  • Unilateral Radiculopathy
  • Limited SLR (Less than 60 degree)
  • Pain on Numeric Pain Rating Scale < 7
  • BMI ≤ 30

Exclusion Criteria:

  • Severe paraspinal Muscle Spasm
  • Acute prolapse intervertebral disc
  • Bilateral Positive SLR
  • Osteoporotic
  • H/O Spinal Fracture

Sites / Locations

  • Max spine rehab centre, G8 markaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Decompression with 30%

Decompression with 40%

Decompression with 50%

Arm Description

Decompression with 30% and mobilization

Decompression with 40% and mobilization

Decompression with 50% and mobilization

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni-dimensional measure of pain intensity in adults(21). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
SLR through Inclinometer
The Straight Leg Raise (SLR) test is a neurodynamic test. Neurodynamic tests check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. These tests, along with relevant history and decreased range of motion, are considered by some to be the most important physical signs of disc herniation, regardless of the degree of disc injury. SLR is a neural tension test that can be used to rule in or out neural tissue involvement as a result of a space occupying lesion, often a lumbar disc herniation. It is one of the most common neurological tests of the lower limb
Oswestry Disability Index
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Most effective for persistent severe disability while the Roland-Morris is better for mild to moderate disability. Questionnaire examines perceived level of disability in 10 everyday activities of daily living

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
August 5, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04852900
Brief Title
Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy
Official Title
Effects of Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
July 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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 study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.
Detailed Description
Decompression therapy differs from traction-based therapy in that the traction applied to the spine in decompression therapy is typically alternated between lower and higher levels of tension for predetermined periods of time. In either therapy, spinal tension is maintained for the period's typically extending 30-minutes or longer. This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Pain, Radiculopathy, Lumbar, Decompression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decompression with 30%
Arm Type
Experimental
Arm Description
Decompression with 30% and mobilization
Arm Title
Decompression with 40%
Arm Type
Experimental
Arm Description
Decompression with 40% and mobilization
Arm Title
Decompression with 50%
Arm Type
Experimental
Arm Description
Decompression with 50% and mobilization
Intervention Type
Other
Intervention Name(s)
Decompression with 30%
Intervention Description
Hot Pack for 10 mins Soft Tissue Mobilization Muscle Strengthening Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Decompression with 40%
Intervention Description
Hot Pack for 10 mins Soft Tissue Mobilization Muscle Strengthening Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Decompression with 50%
Intervention Description
Hot Pack for 10 mins Soft Tissue Mobilization Muscle Strengthening Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni-dimensional measure of pain intensity in adults(21). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
6th week
Title
SLR through Inclinometer
Description
The Straight Leg Raise (SLR) test is a neurodynamic test. Neurodynamic tests check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. These tests, along with relevant history and decreased range of motion, are considered by some to be the most important physical signs of disc herniation, regardless of the degree of disc injury. SLR is a neural tension test that can be used to rule in or out neural tissue involvement as a result of a space occupying lesion, often a lumbar disc herniation. It is one of the most common neurological tests of the lower limb
Time Frame
6th week
Title
Oswestry Disability Index
Description
Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Most effective for persistent severe disability while the Roland-Morris is better for mild to moderate disability. Questionnaire examines perceived level of disability in 10 everyday activities of daily living
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both Genders Age between 30 to 50 years Unilateral Radiculopathy Limited SLR (Less than 60 degree) Pain on Numeric Pain Rating Scale < 7 BMI ≤ 30 Exclusion Criteria: Severe paraspinal Muscle Spasm Acute prolapse intervertebral disc Bilateral Positive SLR Osteoporotic H/O Spinal Fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazish Rafique, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max spine rehab centre, G8 markaz
City
Islamabad
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28613587
Citation
Alexander CE, Varacallo M. Lumbosacral Radiculopathy. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430837/
Results Reference
background
PubMed Identifier
31788391
Citation
Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
Results Reference
background
PubMed Identifier
28715939
Citation
Chen BL, Guo JB, Zhang HW, Zhang YJ, Zhu Y, Zhang J, Hu HY, Zheng YL, Wang XQ. Surgical versus non-operative treatment for lumbar disc herniation: a systematic review and meta-analysis. Clin Rehabil. 2018 Feb;32(2):146-160. doi: 10.1177/0269215517719952. Epub 2017 Jul 17.
Results Reference
background
PubMed Identifier
26882505
Citation
Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Park KB, Shin BC, Lee MS, Ha IH. Long-Term Course of Alternative and Integrative Therapy for Lumbar Disc Herniation and Risk Factors for Surgery: A Prospective Observational 5-Year Follow-Up Study. Spine (Phila Pa 1976). 2016 Aug 15;41(16):E955-E963. doi: 10.1097/BRS.0000000000001494.
Results Reference
background
PubMed Identifier
22543563
Citation
Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
Results Reference
background
Citation
Abdurrahman G, Şener Ü, Karabacak H, Kağan Ü. Kadın ve erkek genç erişkinler arasında fiziksel aktivite ve yaşam kalitesi farklılıklarının araştırılması. Kocatepe Tıp Dergisi. 2011;12(3):145-50.
Results Reference
background
PubMed Identifier
28505956
Citation
Demirel A, Yorubulut M, Ergun N. Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1015-1022. doi: 10.3233/BMR-169581.
Results Reference
background
Citation
Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.
Results Reference
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Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

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