- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329205
Femoral Nerve Mobilization for Patients With Knee Osteoarthritis (RCT)
Effects of Femoral Nerve Mobilization on Pain Intensity, Function, Quality of Life and Central Sensitization in Patients With Knee Osteoarthritis
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed Hegazy, Phd
- Phone Number: 00966115886387 00966566169893
- Email: mohamed.mostafa@pt.cu.edu.eg
Study Locations
-
-
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Al Kharj, Saudi Arabia, 16242
- Prince Sattam bin Abdulaziz University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Traditional physical therapy
|
stretching exercises for hamstring, calf muscles and iliotibial band in addition to isotonic exercise for hip extensors and abductors and isometric quadriceps exercise
|
|
Experimental: Neural mobilization group
traditional physical therapy plus femoral nerve mobilization
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stretching exercises for hamstring, calf muscles and iliotibial band in addition to isotonic exercise for hip extensors and abductors and isometric quadriceps exercise
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: after 4 weeks
|
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
Time Frame: after 4 weeks
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Yamasaki T, Nakajima H. [Glycogenosis type VII (glycogen storage disease type VII, human muscle-phosphofructokinase deficiency, Tarui's disease)]. Ryoikibetsu Shokogun Shirizu. 2001;(36):28-34. No abstract available. Japanese.
- Franklin-Tong VE. Signaling in pollination. Curr Opin Plant Biol. 1999 Dec;2(6):490-5. doi: 10.1016/s1369-5266(99)00017-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/025/015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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