Clinical Trials Directory

Trials / Completed

CompletedNCT07234071

Manual Therapy Combined With Functional Magnetic Stimulation for Lumbar Radiculopathy

The Effectiveness of Manual Therapy Combined With Functional Magnetic Stimulation in Individuals With Lumbar Radiculopathy Due to Lumbar Disc Herniation: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
International Hellenic University · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERCombined manual therapy and Functional Magnetic StimulationParticipants 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.
OTHERManual Therapy without Functional Magnetic StimulationParticipants 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.

Timeline

Start date
2025-11-05
Primary completion
2025-12-10
Completion
2025-12-10
First posted
2025-11-18
Last updated
2026-01-12

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT07234071. Inclusion in this directory is not an endorsement.