Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

Lumbar Radiculopathy Clinical Trial

Official title:

Effects of Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852900
• Other study ID #: REC/00856 Iqra Hamid
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

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