Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy

NCT04674917 | Completed DMC

• 1 other identifier: REC/LHR/20/1051 Mariam Waseem
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Radiculopathy

Keywords

Decompression, radiculopathy, acute, chronic

Outcome Measures

Primary Outcomes (1)

• 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

  4th week

Secondary Outcomes (1)

• MODIFIED OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE

  4th Week

Other Outcomes (1)

• Inclinometer

  4th Week

Study Arms (3)

Group A

EXPERIMENTAL

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Other: Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Group B

EXPERIMENTAL

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Other: Decompression + Hot pack , TENS , Mobilization , Exercise Therapy

Group C

OTHER

Hot pack , TENS, Mobilization, Exercise therapy

Other: Hot pack , TENS, Mobilization, Exercise therapy

Interventions

Decompression + Hot pack , TENS , Mobilization , Exercise Therapy OTHER

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 1. Hot Pack 2. TENSE 3. 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.

Group B

Hot pack , TENS, Mobilization, Exercise therapy OTHER

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 1. Hot Pack 2. TENSE 3. 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.

Group C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ hospital

Daska Kalan, Punjab Province, Pakistan

Location

Related Publications (15)

• 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.

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• 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.

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  PMID: 31078315 BACKGROUND

• 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.

  PMID: 32246656 BACKGROUND

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  PMID: 31015852 BACKGROUND

• 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.

  PMID: 28624722 BACKGROUND

• 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.

  PMID: 27838140 BACKGROUND

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  PMID: 30961554 BACKGROUND

• 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.

  BACKGROUND

• 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.

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• Kisner C, Colby LA, Borstad J. Therapeutic exercise: foundations and techniques: Fa Davis; 2017.

  BACKGROUND

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  PMID: 26813755 BACKGROUND

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• 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.

  PMID: 32709513 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Bronchiolitis Obliterans Syndrome

Interventions

Decompression; Transcutaneous Electric Nerve Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Syed Shakil Ur Rehman

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 19, 2020
• Study Start: March 30, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)