Manual Therapy Combined With Functional Magnetic Stimulation for Lumbar Radiculopathy

NCT07234071 | Completed

• 1 other identifier: EC-16/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial will evaluate whether adding Functional Magnetic Stimulation (FMS) to manual therapy (neurodynamic mobilization) improves clinical outcomes in adults with lumbar radiculopathy caused by lumbar disc herniation. Forty participants will be randomly assigned to two groups: an intervention group receiving manual therapy combined with FMS and a control group receiving manual therapy alone. All participants will complete a three-week physiotherapy program consisting of ten treatment sessions. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcomes include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) range of motion measured with goniometry, and neuropathic symptom characteristics (S-LANSS, Greek). The study aims to determine whether the addition of FMS produces superior clinical improvements compared with manual therapy alone.

Conditions

Lumbar Disc Herniation With Radiculopathy

Keywords

Lumbar Radiculopathy; Low Back Pain; Root Compression, Neuropathic Pain; Acute Radicular Pain

Outcome Measures

Primary Outcomes (4)

• Changes in pain intensity with Numeric Rating Scale (NPRS)

  Changes in pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10. A score of 0 represents "no pain", while 10 represents "the worst possible pain". Two separate pain ratings will be recorded: lumbar pain (NPRS-Lumbar pain) and radicular leg pain (NPRS-Leg pain). Participants will be asked to select the number that best reflects their average pain intensity. The NPRS is a widely accepted tool for evaluating pain in both clinical and research settings, demonstrating excellent test-retest reliability and strong construct validity (Childs et al., 2005).

  pre-treatment, week 3

• Straight Leg Raise (SLR) Angle - Goniometry/SROM

  Neural mechanosensitivity will be assessed with the passive Straight Leg Raise (SLR) measured using a universal goniometer (SROM). With the participant supine, the hip is passively flexed with the knee extended while the pelvis is stabilized. The assessor records: the Symptom Onset Angle (SOA)-the hip flexion angle (°) at which the participant's typical radicular symptoms first appear. Standardized sensitization maneuvers (e.g., ankle dorsiflexion) may be applied consistently to confirm neural involvement. Higher angles indicate reduced neural mechanosensitivity. The SLR SROM shows good repeatability when the procedure and landmarks are standardized.

  pre-treatment, week 3

• Change in Functional Disability

  Functional disability will be evaluated using the Roland-Morris Disability Questionnaire (RMDQ), a self-administered instrument specifically designed to measure the impact of low back pain on daily functioning. The questionnaire consists of 24 statements related to physical activities and functional limitations commonly affected by back pain. Participants are asked to mark each statement that applies to them on the day of assessment. The total score ranges from 0 to 24, with higher scores indicating greater disability and reduced functional capacity. The RMDQ is a validated, reliable, and sensitive tool frequently used in both clinical and research contexts to monitor changes in function over time in individuals with low back pain.

  pre-treatment, week 3

• Change in Neuropathic Symptom Profile - S-LANSS

  Neuropathic pain features will be evaluated with the Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item questionnaire producing a total score from 0 to 24. Items capture characteristic symptoms (e.g., burning, electric shocks, paresthesias) and symptom behavior. Scores ≥12 suggest pain predominantly of neuropathic origin. The S-LANSS is brief, easy to administer, and has demonstrated acceptable reliability and validity for screening neuropathic pain components and monitoring change over time.

  pre-treatment, week 3

Study Arms (2)

Manual Therapy and Functional Magnetic Stimulation

EXPERIMENTAL

Participants allocated to this group will receive 10 sessions of manual therapy with Functional Magnetic Stimulation

Other: Combined manual therapy and Functional Magnetic Stimulation

Manual Therapy without Functional Magnetic Stimulation

ACTIVE COMPARATOR

Participants allocated to this group will receive 10 sessions of a Manual Therapy without Functional Magnetic Stimulation.

Other: Manual Therapy without Functional Magnetic Stimulation

Interventions

Combined manual therapy and Functional Magnetic Stimulation OTHER

Participants allocated to this group will receive a combined program consisting of neurodynamic manual therapy and Functional Magnetic Stimulation (FMS). The manual therapy protocol includes symptom-guided spinal mobilization with leg movement and standardized sciatic nerve mobilization techniques. FMS will be applied using a high-intensity magnetic stimulator targeting the lumbosacral nerve roots and the sciatic nerve pathway. A total of 10 treatment sessions will be administered over a 3-week period.

Manual Therapy and Functional Magnetic Stimulation

Manual Therapy without Functional Magnetic Stimulation OTHER

Participants in this group will receive the same neurodynamic manual therapy protocol as the experimental group, including symptom-guided spinal mobilization with leg movement and sciatic nerve mobilization techniques. However, they will not receive Functional Magnetic Stimulation (FMS). A total of 10 treatment sessions will be administered over the 3-week intervention period.

Manual Therapy without Functional Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Candidates will be excluded if any of the following conditions are present:
• Clinical "red flag" indicators such as cauda equina syndrome, suspected spinal infection, or oncologic disease.
• Bilateral radicular involvement or symptoms inconsistent with a single-level LDHR.
• Previous lumbar spine surgery or an upcoming surgical intervention scheduled during the study period.
• Receipt of invasive pain-management procedures (e.g., epidural steroid injections) within the last six weeks.
• Coexisting severe neurologic, metabolic, or inflammatory rheumatologic diseases unrelated to the lumbar radiculopathy.
• Contraindications to magnetic stimulation, including pacemakers, spinal or peripheral neurostimulators, cochlear implants, or clinically significant metallic implants in the stimulation field.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

International Hellenic University

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Radiculopathy; Low Back Pain; Neuralgia

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor) A masked assessor will conduct the measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Model Details: A single-assessor-blind randomized controlled trial will be conducted over three weeks in forty adults with lumbar radiculopathy due to lumbar disc herniation. Participants will be randomly allocated 1:1 (n = 20 per group) to either: (1) manual therapy (neurodynamic mobilization) combined with Functional Magnetic Stimulation (FMS), or (2) the same manual therapy protocol without FMS. Both groups will complete ten treatment sessions during the three-week period. Clinical assessments-including pain intensity (Numeric Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), straight leg raise (SLR) angle measured with goniometry, and neuropathic symptoms (S-LANSS, Greek)-will be obtained at baseline and at the end of the three-week intervention.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 5, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)