Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy
Primary Purpose
Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Decompression + Hot pack , TENS , Mobilization , Exercise Therapy
Hot pack , TENS, Mobilization, Exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Decompression, radiculopathy, acute, chronic
Eligibility Criteria
Inclusion Criteria:
- history of radicular pain with straight leg raise (SLR).
- Patients in the acute phase of (up to 6 weeks) included in group A
- Patients in chronic phase of (more than 6 weeks) included in group B
Exclusion Criteria:
- Any systemic soft tissue and bony disease.
- Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
- Any recent surgery.
- Patient with any cervical or thoracic problem.
- Patients with any other serious pathology/red flags
Sites / Locations
- DHQ hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Group A
Group B
Group C
Arm Description
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Hot pack , TENS, Mobilization, Exercise therapy
Outcomes
Primary Outcome Measures
Visual Analogue Scale
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
Secondary Outcome Measures
MODIFIED OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Full Information
NCT ID
NCT04674917
First Posted
December 16, 2020
Last Updated
March 4, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04674917
Brief Title
Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy
Official Title
Effects of Decompression on Pain, Range of Motion and Function in Patient With Acute vs Chronic Lumbar Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 30, 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
Yes
5. Study Description
Brief Summary
The study will be done to evaluate the effectiveness of Lumbar Spinal Decompression in patients with acute vs chronic lumbar radiculopathy. Study design will be Randomized control trial and sample size will be 30. Duration of study was of 6 month, convenient sampling was done. Data will be collected from DHQ Daska were randomly allocated in three groups via lottery method, baseline assessment was done. Patients of both gender (male and female) from 18 to 50 years with lumbar radiculopathy diagnosed through X-ray and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week. Whole procedure of treatment program will given to patients and written informed consent will be taken. Basic tools will be Visual analog scale (VAS), SLR, ODI, Inclinometer. Data was analyzed by using SPSS version 21
Detailed Description
Low back pain (LBP) is one of the most common musculoskeletal conditions treated by physical therapists. Although lumbar traction is frequently used by physical therapists in the treatment of patients with LBP. We will use Manual Lumber Spinal Traction on patients with acute vs chronic lumber radiculopathy. The current study will determine the effect of decompression in relieving pain, increase range of motion and improving function in patients of acute and chronic lumbar radiculopathy. Lumbar traction (LT) is routinely used on its own or in conjunction with other treatments for the management of lumbar sciatica. We will use Manual lumbar traction along with hot pack, tens, mobilization and exercise therapy. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Decompression, radiculopathy, acute, chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Arm Title
Group B
Arm Type
Experimental
Arm Description
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Arm Title
Group C
Arm Type
Other
Arm Description
Hot pack , TENS, Mobilization, Exercise therapy
Intervention Type
Other
Intervention Name(s)
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Intervention Description
Group A which includes the acute group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..
The basic treatments are
Hot Pack
TENSE
Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.
Intervention Type
Other
Intervention Name(s)
Decompression + Hot pack , TENS , Mobilization , Exercise Therapy
Intervention Description
Group B which includes the chronic group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..
The basic treatments are
Hot Pack
TENSE
Mobilization ( on lumbar L1 toL5 )
Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.
Intervention Type
Other
Intervention Name(s)
Hot pack , TENS, Mobilization, Exercise therapy
Intervention Description
Group C which is our control group to compare it with the groups A and B to study the effects of decompression on lumbar radiculopathy The basic treatments are
Hot Pack
TENSE
Mobilization ( on lumbar L1 toL5 )
Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
The third treatment which is mobilization will be given 1 time on each joint of lumbar spine It is kept in mind that in this group we will not apply the decompression along with the above treatments.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
Time Frame
4th week
Secondary Outcome Measure Information:
Title
MODIFIED OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Time Frame
4th Week
Other Pre-specified Outcome Measures:
Title
Inclinometer
Description
An inclinometer or clinometer is an instrument used for measuring angles of slope (or tilt), elevation, or depression of an object with respect to gravity's direction.
Time Frame
4th Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history of radicular pain with straight leg raise (SLR).
Patients in the acute phase of (up to 6 weeks) included in group A
Patients in chronic phase of (more than 6 weeks) included in group B
Exclusion Criteria:
Any systemic soft tissue and bony disease.
Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
Any recent surgery.
Patient with any cervical or thoracic problem.
Patients with any other serious pathology/red flags
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ hospital
City
Daska
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31456418
Citation
Cheng YH, Hsu CY, Lin YN. The effect of mechanical traction on low back pain in patients with herniated intervertebral disks: a systemic review and meta-analysis. Clin Rehabil. 2020 Jan;34(1):13-22. doi: 10.1177/0269215519872528. Epub 2019 Aug 28.
Results Reference
background
PubMed Identifier
27559274
Citation
Swanson BT, Riley SP, Cote MP, Leger RR, Moss IL, Carlos J Jr. Manual unloading of the lumbar spine: can it identify immediate responders to mechanical traction in a low back pain population? A study of reliability and criterion referenced predictive validity. J Man Manip Ther. 2016 May;24(2):53-61. doi: 10.1179/2042618614Y.0000000072.
Results Reference
background
PubMed Identifier
31078315
Citation
Rubinic DM, Koo V, Dudley J, Owens SC. Changes in Spinal Height After Manual Axial Traction or Side Lying: A Clinical Measure of Intervertebral Disc Hydration Using Stadiometry. J Manipulative Physiol Ther. 2019 Mar-Apr;42(3):187-194. doi: 10.1016/j.jmpt.2019.03.005. Epub 2019 May 9.
Results Reference
background
PubMed Identifier
32246656
Citation
Asiri F, Tedla JS, D Alshahrani MS, Ahmed I, Reddy RS, Gular K. Effects of patient-specific three-dimensional lumbar traction on pain and functional disability in patients with lumbar intervertebral disc prolapse. Niger J Clin Pract. 2020 Apr;23(4):498-502. doi: 10.4103/njcp.njcp_285_19.
Results Reference
background
PubMed Identifier
31015852
Citation
Mo Z, Li D, Zhang R, Chang M, Yang B, Tang S. Comparisons of the Effectiveness and Safety of Tuina, Acupuncture, Traction, and Chinese Herbs for Lumbar Disc Herniation: A Systematic Review and Network Meta-Analysis. Evid Based Complement Alternat Med. 2019 Mar 20;2019:6821310. doi: 10.1155/2019/6821310. eCollection 2019.
Results Reference
background
PubMed Identifier
28624722
Citation
Mitchell UH, Beattie PF, Bowden J, Larson R, Wang H. Age-related differences in the response of the L5-S1 intervertebral disc to spinal traction. Musculoskelet Sci Pract. 2017 Oct;31:1-8. doi: 10.1016/j.msksp.2017.06.004. Epub 2017 Jun 9.
Results Reference
background
PubMed Identifier
27838140
Citation
Isner-Horobeti ME, Dufour SP, Schaeffer M, Sauleau E, Vautravers P, Lecocq J, Dupeyron A. High-Force Versus Low-Force Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation: A Preliminary Randomized Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):645-654. doi: 10.1016/j.jmpt.2016.09.006. Epub 2016 Nov 9.
Results Reference
background
PubMed Identifier
30961554
Citation
Tadano S, Tanabe H, Arai S, Fujino K, Doi T, Akai M. Lumbar mechanical traction: a biomechanical assessment of change at the lumbar spine. BMC Musculoskelet Disord. 2019 Apr 9;20(1):155. doi: 10.1186/s12891-019-2545-9.
Results Reference
background
Citation
Creighton D, Schweiger A, Cubr S. Immediate Effects of Side Lying Manual Lumbar Traction in Patients with Painful Active Lumbar Motion. Journal of International Academy of Physical Therapy Research. 2017;8(1):1071-6.
Results Reference
background
PubMed Identifier
30568333
Citation
Oh H, Choi S, Lee S, Choi J, Lee K. The impact of manual spinal traction therapy on the pain and Oswestry disability index of patients with chronic back pain. J Phys Ther Sci. 2018 Dec;30(12):1455-1457. doi: 10.1589/jpts.30.1455. Epub 2018 Nov 21.
Results Reference
background
Citation
Kisner C, Colby LA, Borstad J. Therapeutic exercise: foundations and techniques: Fa Davis; 2017.
Results Reference
background
PubMed Identifier
26813755
Citation
Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
Results Reference
background
PubMed Identifier
26418868
Citation
Szulc P, Wendt M, Waszak M, Tomczak M, Cieslik K, Trzaska T. Impact of McKenzie Method Therapy Enriched by Muscular Energy Techniques on Subjective and Objective Parameters Related to Spine Function in Patients with Chronic Low Back Pain. Med Sci Monit. 2015 Sep 29;21:2918-32. doi: 10.12659/MSM.894261.
Results Reference
background
PubMed Identifier
32723102
Citation
Lo WLA, Lei D, Leng Y, Huang H, Wang B, Yu Q, Li L. Impact of nonsurgical spinal decompression on paraspinal muscle morphology and mechanical properties in young adults with low back pain. J Int Med Res. 2020 Jul;48(7):300060520919232. doi: 10.1177/0300060520919232.
Results Reference
background
PubMed Identifier
32709513
Citation
Hallur SS, Brismee JM, Sizer PS, Dierick F, Dewan BM, Thiry P, Sobczak S. Three-Dimensional Spinal Position With and Without Manual Distraction Load Increases Spinal Height. J Manipulative Physiol Ther. 2020 May;43(4):267-275. doi: 10.1016/j.jmpt.2019.04.007. Epub 2020 Jul 21.
Results Reference
background
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Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy
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