Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy

Lumbar Radiculopathy Clinical Trial

Official title:

Effects of Decompression on Pain, Range of Motion and Function in Patient With Acute vs Chronic Lumbar Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674917
• Other study ID #: REC/LHR/20/1051 Mariam Waseem
• Status: Completed
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: March 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Other:
• Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
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.
• Decompression + Hot pack , TENS , Mobilization , Exercise Therapy
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.
• Hot pack , TENS, Mobilization, Exercise therapy
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.

Locations

Country	Name	City	State
Pakistan	DHQ hospital	Daska	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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. — View 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. — View 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.

Hallur SS, Brismée 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. — View 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. — View Citation

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

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inclinometer	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.	4th Week
Primary	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	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	4th Week