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

NCT07119697 | Completed DMC

• 1 other identifier: RRC-2021-10
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Keywords

Oswestry Disability Index (ODI); McKenzie Method; Neural Mobilization; Radiculopathy; Exercise Therapy; Rehabilitation Outcome

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  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.

  3 weeks

• Functional Disability

  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 weeks

• Lumbar Range of Motion

  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.

  3 weeks

• Neurodynamic Assessment

  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.

  3 weeks

Study Arms (2)

SNM Group

EXPERIMENTAL

SNM Group exhibited 22 participants who received allocated intervention, including Shacklock Neural Mobilization and hydrocollator packs for 15-20 minutes per session, 3-5 days weekly for three weeks.

Other: Shacklock Neural Mobilization; Other: Hydrocollator hot packs

MEP Group

ACTIVE COMPARATOR

MEP Group exhibited 22 participants who received allocated intervention, including the McKenzie Extension Principle and hydrocollator packs for 15-20 minutes per session, 3-5 days weekly for three weeks.

Other: McKenzie Extension Principle; Other: Hydrocollator hot packs

Interventions

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.

SNM Group

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.

MEP Group

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.

MEP Group; SNM Group

Eligibility Criteria

• Age: 25 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University Hospital

Riyadh, 10219, Saudi Arabia

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Prof. Ahmad H. Alghadir, PhD

  Rehabilitation Reseach Chair; King Saud University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: April 7, 2021
• Primary Completion: July 19, 2021
• Study Completion: November 26, 2021
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 weeks
• Access Criteria: Peer reviewing intended

Locations

SA (1)