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

• Sponsor: Foundation University Islamabad (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05314049
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Disk Prolapse; Disk Herniated Lumbar; Sciatic Radiculopathy	Procedure: Mckenzie Extension Protocol; Procedure: Lumbar SNAGs; Device: inferential therapy; Device: Heat Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Back Pain [2 weeks]

   Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.

2. Lumbar Range of Motion [2 weeks]

   Disability will be measured via inclinometer. A higher score signifies good outcome.

3. Postural Stability [2 weeks]

   Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.

4. Lumbar Disability [2 weeks]

   Disability will be measured via Oswestry Disability Index.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Foundation University Islamabad
• ClinicalTrials.gov Identifier: NCT05314049
• Other Study ID Numbers: FUI/CTR/2022/4
• First Posted: Apr 6, 2022
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Back Pain; Low Back Pain; Prolapse

Study Results

No Results Posted as of Apr 6, 2022