Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04852900
Other study ID # REC/00856 Iqra Hamid
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date July 10, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 10, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Decompression with 30%
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
Decompression with 40%
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
Decompression with 50%
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

Locations

Country Name City State
Pakistan Max spine rehab centre, G8 markaz Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Abdurrahman G, Sener Ü, Karabacak H, Kagan Ü. Kadin ve erkek genç eriskinler arasinda fiziksel aktivite ve yasam kalitesi farkliliklarinin arastirilmasi. Kocatepe Tip Dergisi. 2011;12(3):145-50.

Alexander CE, Varacallo M. Lumbosacral Radiculopathy. StatPearls [Internet]: StatPearls Publishing; 2019.

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

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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"). 6th week
Primary 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 6th week
Primary 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 6th week
See also
  Status Clinical Trial Phase
Terminated NCT05047679 - The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy N/A
Withdrawn NCT03543033 - Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT03133845 - Shaping Anesthetic Techniques to Reduce Post-operative Delirium N/A
Completed NCT06087107 - Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy N/A
Terminated NCT05022251 - Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Recruiting NCT04212949 - The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy N/A
Terminated NCT03952377 - Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain Phase 1/Phase 2
Recruiting NCT06339931 - Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy. N/A
Recruiting NCT04540068 - Prediction of TEI Success in Sciatica
Recruiting NCT05953727 - Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients N/A
Recruiting NCT05922228 - Effects of Neural Flossing and PNF on Lumbar Radiculopathy N/A
Completed NCT05449288 - Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
Completed NCT05874427 - Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form N/A
Terminated NCT01443819 - Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy Phase 3
Recruiting NCT05535010 - The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy. N/A
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Completed NCT04674917 - Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy N/A
Not yet recruiting NCT06296303 - Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients N/A
Completed NCT04887285 - Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections N/A