International Hellenic University
Thessaloniki, Greece
NCT Number: NCT07234071
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.
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Notify Me18 year–64 year
All sexes
Interventional
Not applicable
Thessaloniki, Greece
Background: Lumbar disc herniation with radiculopathy is a common musculoskeletal and neurological condition caused by compression or irritation of the lumbar nerve roots, often leading to radiating leg pain, paresthesia, and movement limitation. Neural (neurodynamic) mobilization is a manual physiotherapy technique aiming to restore the mechanical and physiological interface between neural tissues and their surrounding structures, thereby improving nerve mobility and reducing mechanosensitivity. Functional Magnetic Stimulation (FMS) is a non-invasive modality that induces deep neuromuscular activation through rapidly changing magnetic fields, potentially enhancing circulation, muscle recruitment, and neural responsiveness. Although FMS has shown promise in both neurological and musculoskeletal disorders, its combined use with neural mobilization in patients with lumbar radiculopathy has not yet been evaluated in a controlled clinical environment.
Aim: This randomized controlled trial aims to investigate the effectiveness of combining manual therapy with Functional Magnetic Stimulation in adults with chronic lumbar radiculopathy due to lumbar disc herniation. The primary objective is to determine whether the combined intervention provides greater reductions in pain, improved functional capacity, and better neuropathic symptom profiles compared with manual therapy alone.
Method: Forty adults aged 18-64 years with clinically and MRI-confirmed lumbar radiculopathy will be randomly assigned to two groups. The intervention group will participate in a three-week physiotherapy program consisting of manual therapy techniques and Functional Magnetic Stimulation applied 3-4 times per week (10 sessions total). The control group will receive the same manual therapy protocol without FMS. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcome measures include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) angle measured with a goniometer, and neuropathic pain features (S-LANSS, Greek). A mixed-model repeated-measures ANOVA will be used for statistical analysis, with significance set at p < .05.
Expected Results: It is anticipated that individuals receiving the combined manual therapy and FMS intervention will demonstrate greater improvements in pain intensity, functional capacity, and neuropathic symptom characteristics compared with those receiving manual therapy alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants will be eligible for enrollment if they meet all of the following conditions:
Exclusion criteria
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.
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.
Time frame: pre-treatment, week 3
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).
Time frame: pre-treatment, week 3
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.
Time frame: pre-treatment, week 3
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.
Time frame: pre-treatment, week 3
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.
International Hellenic University
Other
The Effectiveness of Manual Therapy Combined With Functional Magnetic Stimulation in Individuals With Lumbar Radiculopathy Due to Lumbar Disc Herniation: A Randomized Controlled Trial
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