Lumbar RadiculopathyNCT07119697
Shacklock Neural Mobilization vs. McKenzie on Pain and Functional Disability in Lumbar Radiculopathy
A study testing Shacklock Neural Mobilization, McKenzie Extension Principle and Hydrocollator hot packs in people with Lumbar Radiculopathy, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Shacklock Neural Mobilization, McKenzie Extension Principle and Hydrocollator hot packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Apr 2021to 26 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Shacklock Neural Mobilization vs. McKenzie Extension Principle in Lumbar Radiculopathy: A Randomized Comparative Trial on Pain and Functional Disability
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.
Read the 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
- Being tested
- Shacklock Neural Mobilization, McKenzie Extension Principle, Hydrocollator hot packs
- Keywords
- Oswestry Disability Index (ODI), McKenzie Method, Neural Mobilization, Radiculopathy, Exercise Therapy, Rehabilitation Outcome
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shacklock Neural MobilizationOther
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 PrincipleOther
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 packsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: McKenzie Extension Principle; Other: Hydrocollator hot packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start7 Apr 2021
- Primary completion19 Jul 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- Prof. Ahmad H. Alghadir, PhD, Study chair, Rehabilitation Reseach Chair; King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119697
- Sponsor's protocol ID
- RRC-2021-10
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study title, brief and descriptive summary, Methodology, including, Study design, setting, Study protocol, outcomes, iterventions may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shacklock Neural Mobilization vs. McKenzie Extension Principle in Lumbar Radiculopathy: A Randomized Comparative Trial on Pain and Functional Disability
- ClinicalTrials.gov ID
- NCT07119697
- Acronym / sponsor ID
- RRC-2021-10
- Conditions
- Lumbar Radiculopathy
- Keywords
- Oswestry Disability Index (ODI), McKenzie Method, Neural Mobilization, Radiculopathy, Exercise Therapy, Rehabilitation Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNM Group | Experimental | Other: Shacklock Neural Mobilization, Other: Hydrocollator hot packsSNM 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. |
| MEP Group | Active comparator | Other: McKenzie Extension Principle, Other: Hydrocollator hot packsMEP 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. |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shacklock Neural MobilizationIn 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. | Other | SNM Group |
| McKenzie Extension PrincipleMEP 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. | Other | MEP Group |
| Hydrocollator hot packsBoth 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. | Other | MEP Group, SNM Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Yes. Study title, brief and descriptive summary, Methodology, including, Study design, setting, Study protocol, outcomes, iterventions may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Ahmad H. Alghadir, PhD study chair
Rehabilitation Reseach Chair; King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shacklock Neural Mobilization, McKenzie Extension Principle and Hydrocollator hot packs in people with Lumbar Radiculopathy, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.