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Completed

NCT Number: NCT07119697

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

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.

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Key information

Conditions

Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

25 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University Hospital

Riyadh, 10219, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Shacklock Neural Mobilization

Other

In the SNM group, participants lay supine with hips neutral and knees flexed to 45 degrees. Therapists applied the remote slider technique by extending the knee near end-range and dorsiflexing the ankle to 15 degrees, performed in 3 sets of 15 reps with 30-second rests. Each session lasted 20 minutes including setup. Progression was made by increasing hip flexion in 5 degrees increments when a VAS pain reduction of ≥2 cm was observed. This technique, based on neurodynamic principles, was designed to reduce neural mechanosensitivity and improve mobility in patients with lumbar radiculopathy.

McKenzie Extension Principle

Other

MEP group was treated with MEP in a prone position, starting with 10 repetitions of active trunk extension, holding end-range for 3 seconds. If no symptom centralization occurred, therapists progressed from patient-applied overpressure (EIL-POP) to clinician-applied grade III mobilizations (3 oscillations/second), following McKenzie's force progression model. Each session included 3 sets of 10 repetitions with 1-minute rest between sets, totaling 15 minutes of active intervention. For unilateral symptoms, the approach advanced to hips-off-center techniques involving a 15 degree lateral shift. This graded sequence aimed to reduce nerve root compression and promote symptom centralization.

Hydrocollator hot packs

Other

Both groups received standardized thermotherapy using hydrocollator-heated moist hot packs (40 degrees centigrade, wrapped in 6-8 towel layers) applied to the lumbar region for 15-20 minutes to improve tissue compliance and reduce pain. Participants were positioned prone or side-lying based on comfort and symptom severity; semi-prone positions with pillow support were used for those with heightened sensitivity to maintain spinal neutrality. Thermotherapy was administered five times in week 1 and three times weekly during weeks 2-3. Skin condition and comfort were monitored. This pre-treatment method promoted transient pain relief and muscle relaxation, enhancing tolerance to subsequent therapeutic interventions.

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Functional Disability

    Time frame: 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.

  3. Lumbar Range of Motion

    Time frame: 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.

  4. Neurodynamic Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Efficacy of Shacklock Neural Mobilization vs. McKenzie Extension Principle in Lumbar Radiculopathy: A Randomized Comparative Trial on Pain and Functional Disability

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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