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

NCT ID: NCT07119697

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2021-11-26

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.

Conditions

Lumbar Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SNM Group

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.

Group Type: EXPERIMENTAL

Shacklock Neural Mobilization

Intervention Type: 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.

Hydrocollator hot packs

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

McKenzie Extension Principle

Intervention Type: 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

Intervention Type: 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.

Interventions

Shacklock Neural Mobilization

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.

Intervention Type: OTHER

McKenzie Extension Principle

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.

Intervention Type: OTHER

Hydrocollator hot packs

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

AMIR IQBAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Ahmad H. Alghadir, PhD

Role: STUDY_CHAIR

Rehabilitation Reseach Chair; King Saud University

Locations

King Saud University Hospital

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RRC-2021-10

Identifier Type: -

Identifier Source: org_study_id