Ignite Creation Date:
2025-12-18 @ 8:49 AM
Ignite Modification Date:
2025-12-23 @ 7:05 PM
Study NCT ID:
NCT07234071
Status:
None
Last Update Posted:
2025-11-28 00:00:00
First Post:
2025-11-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Therapy Combined With Functional Magnetic Stimulation for Lumbar Radiculopathy
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 18-65 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.
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 18-65 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: