Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain

Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain

Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Disk Herniated Lumbar; Sciatic Radiculopathy; Disk Prolapse
• Intervention / Treatment: Procedure: Mckenzie Extension Protocol; Procedure: Lumbar SNAGs; Device: inferential therapy; Device: Heat Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Osama, PhD*; Phone Number: +923325540436; Email: osama@fui.edu.pk
• Study Contact Backup: Name: Muhammad Osama, PhD*; Email: osama@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both male and female participants
• aged 18-50 years old
• low back pain intensity less than 80/100mm on visual analogue scale
• positive centralization phenomenon
• low signal intensity of IV disc on T2 - weighted MRI
• high intensity zone towards the posterior aspect of the disc on MRI

Exclusion Criteria:

Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Procedure: Mckenzie Extension Protocol; Mckenzie Extension Exercise Protocol will be performed by participants in prone position; Procedure: Lumbar SNAGs; Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position; Device: inferential therapy; 4 pole inferential therapy in combination with superficial heating for 20 minutes; Device: Heat Therapy; superficial heating for 20 minutes
Active Comparator: Active Comparator Group	Procedure: Mckenzie Extension Protocol; Mckenzie Extension Exercise Protocol will be performed by participants in prone position; Device: inferential therapy; 4 pole inferential therapy in combination with superficial heating for 20 minutes; Device: Heat Therapy; superficial heating for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back Pain	Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.	2 weeks
Lumbar Range of Motion	Disability will be measured via inclinometer. A higher score signifies good outcome.	2 weeks
Postural Stability	Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.	2 weeks
Lumbar Disability	Disability will be measured via Oswestry Disability Index.	2 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Prolapse; Radiculopathy
• Other Study ID Numbers: FUI/CTR/2022/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No