NCT07329205

Brief Summary

Background: Knee osteoarthritis (KO) is considered as a cause of disability among the elderly, causing pain, reduced quality of life, and decreased functionality. There is a limited knowledge about using femoral nerve mobilization in treating patients with arthritic changes. Objectives: This study will be designed to determine the efficacy of adding of femoral nerve mobilization on pain intensity, function, quality of life and central sensitization in patients with knee osteoarthritis Methods: Thirty patients (aged ≥50 years with KO Kellgren-Lawrence grades I-II) will be included in this study: Patients will randomly be assigned into two groups: group A will receive traditional physical therapy while group B will receive femoral nerve mobilization in addition to traditional physical therapy. Three sessions will be performed for four weeks by 3 session /week. Patients will be evaluated for pain intensity using the numerical rating scale (NRS), knee function by WOMAC scale, quality of life by 12-item Short Form Survey questionnaire (SF-12) and central sensitization by the Arabic version of central sensitization inventory (CSI).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 15, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

NEURAL MOBILIZATIONKnee osteoarthritisconventional physical therapy

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    The pain was assessed by the numerical rating scale (NRS) where zero indicating no pain and 10 indicating maximal pain

    after 4 weeks

  • central sensitization

    The CSI is a validated questionnaire designed to identify symptoms associated with central sensitization. It has two components: Scale A assesses 25 common symptoms in individuals with central sensitization, resulting in a score ranging from 0 to 100. This score was interpreted as follows: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), and extreme (60-100). Scale B, which is not scored, collects information on previous diagnoses of specific diseases

    after 4 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Traditional physical therapy

Other: traditional physical therapy

Neural mobilization group

EXPERIMENTAL

traditional physical therapy plus femoral nerve mobilization

Other: traditional physical therapyOther: Femoral nerve mobilization

Interventions

stretching exercises for hamstring, calf muscles and iliotibial band in addition to isotonic exercise for hip extensors and abductors and isometric quadriceps exercise

Control groupNeural mobilization group

A physiotherapist guided the patients in performing active mobilization of the femoral nerve. The prescribed method for active neural mobilization involved assuming a prone position supported by the forearms with a slight extension of the spine, flexion of the knee, and extension of the cervical spine. This was followed by performing the opposite movement

Neural mobilization group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 50 years or older, diagnosed with KO according to theAmerican College of Rheumatology's criteria with knee pain, and grade I or II on the Kellgren-Lawrence radiographic scale

You may not qualify if:

  • individuals suffering from chronic conditions considered to be perpetuating factors (e.g., fibromyalgia)
  • those with conditions causing lower extremity pain
  • individuals who had taken analgesics within 24 h before evaluations
  • those who had undergone corticosteroid or local anesthetic infiltration in the year prior to the study or during the follow-up period
  • those using substances that could interfere with treatment
  • those with a previous diagnosis of neuropathy (lumbosacral plexus) or myopathy
  • those with contraindications to mobilization or exercise, and those with cognitive deficits (dementia, Alzheimer's).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, 16242, Saudi Arabia

Location

Related Publications (3)

  • Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.

  • Serrano-Garcia B, Martinez-Cepa CB, Forriol F, Zuil-Escobar JC. Active Neurodynamic Technique at Home in Patients with Knee Osteoarthritis: An Open Single Arm Clinical Trial. Medicina (Kaunas). 2024 Nov 12;60(11):1857. doi: 10.3390/medicina60111857.

  • Serrano-Garcia B, Forriol-Campos F, Zuil-Escobar JC. Active Neurodynamics at Home in Patients with Knee Osteoarthritis: A Feasibility Study. J Clin Med. 2023 Oct 20;12(20):6635. doi: 10.3390/jcm12206635.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor , department of health and rehabilitation sciences, college of applied medical siences

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 9, 2026

Study Start

December 20, 2025

Primary Completion

February 10, 2026

Study Completion

February 25, 2026

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations