Shacklock Neural Mobilization vs. McKenzie on Pain and Functional Disability in Lumbar Radiculopathy

Not Applicable

Completed

• Conditions: Lumbar Radiculopathy

• Registration Number: NCT07119697
• Lead Sponsor: King Saud University

Brief Summary

This randomized comparative trial evaluates the efficacy of Shacklock neural mobilization versus the McKenzie extension principle in patients with lumbar radiculopathy. The study aims to compare both interventions in terms of their effectiveness in reducing pain and improving functional disability. Outcomes will be measured using validated tools such as the Visual Analog Scale (VAS) for pain and the Oswestry Disability Index (ODI). The trial seeks to inform evidence-based physiotherapeutic approaches for managing lumbar radiculopathy.

Detailed Description

This randomized comparative trial is designed to assess and compare the efficacy of Shacklock Neural Mobilization (SNM) and the McKenzie Extension Principle (MEP) in the management of lumbar radiculopathy. Lumbar radiculopathy is commonly associated with nerve root compression, resulting in significant pain and functional limitations. While SNM focuses on restoring normal neurodynamic mobility and reducing mechanosensitivity of the nervous system, MEP targets spinal mechanical derangements through repeated extension movements. Despite their widespread clinical use, direct comparative evidence on their effectiveness remains limited.

The study utilizes a two-arm, parallel-group design with repeated measures. Participants diagnosed with lumbar radiculopathy were randomly assigned to one of two intervention groups: the SNM group or the MEP group. Each group received their respective intervention over a structured three-week treatment period.

Interventions were administered by qualified physiotherapists following standardized protocols. Pain intensity and functional disability were measured using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI), respectively. Assessments were conducted at baseline and weekly thereafter until the end of the intervention period.

Study Timeline

• Study Start: 2021-04-07
• Primary Completion: 2021-07-19
• Study Completion: 2021-11-26
• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

It required participants to have subacute lumbar radiculopathy (3-6 months duration) with radiating pain to or beyond the knee, with or without neurological signs, and MRI-confirmed mild disc bulge. Eligibility also required meeting at least three of four standardized test item cluster criteria and the ability to read and understand English.

Exclusion Criteria

It included a history of spinal trauma or surgery, presence of systemic diseases (such as rheumatoid arthritis or diabetes), severe disc pathology (e.g., sequestration), spinal deformities (e.g., scoliosis >10°), chronic radiculopathy lasting more than one year, or current use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	3 weeks	Pain intensity was measured using the Visual Analog Scale (VAS), a 10-cm horizontal line anchored by no pain (0) and worst imaginable pain. The VAS is a validated and reliable tool, with excellent test-retest reliability (ICC = 0.94) and strong correlations with other pain measures. Patients marked their pain after a 10-minute rest to minimize activity-induced fluctuations, and assessments were conducted at standardized time points throughout the intervention period.
Functional Disability	3 weeks	The Oswestry Disability Index (ODI) version 2.1a was used to assess functional limitations related to lumbar radiculopathy. This 10-item questionnaire, scored from 0 to 100%, has demonstrated excellent internal consistency (α = 0.90) and test-retest reliability (ICC = 0.91) in lumbar spine conditions. Participants completed the ODI independently under standardized conditions, ensuring accurate assessment of daily activity limitations associated with radiculopathy.
Lumbar Range of Motion	3 weeks	Spinal mobility was objectively assessed using a modified Schober's test combined with digital inclinometry (Baseline® inclinometer). Flexion was measured using Schober's method, while extension was assessed with the inclinometer placed at the T12-L1 level. Three consecutive readings were taken and averaged for each direction following a standardized warm-up protocol to minimize viscoelastic tissue effects and ensure consistency across assessments.
Neurodynamic Assessment	3 weeks	The Straight Leg Raise (SLR) test was conducted using a standardized protocol known for high sensitivity in detecting nerve root compression when combined with ankle dorsiflexion. A Baseline® 12 plastic goniometer was used to measure the angle at which radicular symptoms were first reproduced. The hip was moved at a controlled rate of 10 degree, second to differentiate neural from musculoskeletal responses. This approach allows for consistent and reliable monitoring of neurodynamic changes throughout the intervention period.

Trial Locations

Locations (1)

King Saud University Hospital; 🇸🇦 Riyadh, Saudi Arabia