Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain

Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain: A Randomized Controlled Trial

The goal of this clinical trial is to learn if Feldenkrais method affects balance in patients with mechanical low back pain. The main questions it aims to answer is:

does Feldenkrais method affects balance in patients with mechanical low back pain.

Participants will:

Be assessed for inclusion using slump and straight leg raise tests. Visit the clinic twice every week for sessions. Assessed pre and post treatment using Biodex Balance.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Low Back Pain
• Intervention / Treatment: Other: Feldenkrais Method and Core stabilization; Other: Core stability exercises

Detailed Description

Sample size calculation showed that our sample is 40. Forty patients with mechanical low back pain not referring beyond the knee will be recruited from Souad Kafafi Hospital and multiple outpatient clinics in Giza, Egypt. Inclusion criteria is male or female patients, 18-45 years, mechanical pain for the last 6 months, with no previous surgeries or diseases in the spine. Treatment strategy include 10 treatment sessions for each allocated subject. Core strengthening exercises and Feldenkrais method (balance exercises) are the treatment approached used in this study. Two experienced physical therapists will apply the treatment in the Faculty of Physical therapy clinic. Overall, mediolateral, and anteroposterior stability will be assessed for each patient. The measurement will be done twice pretreatment and immediately after the last session.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed E Fahmy, Instructor; Phone Number: +201114650668; Email: mohamed.khater@must.edu.eg
• Study Contact Backup: Name: Aya A Khalil, Lecturer; Phone Number: +20 11 12204944; Email: aya.abdelhamied@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12582
    • Recruiting
    • Misr University for Science and Technology
    • Contact: Shaimaa N AboElazm, Dean; Phone Number: +201001779151; Email: shaimaa.nabil@must.edu.eg
    • Principal Investigator: Mohamed E Fahmy, Instructor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mechanical back pain.
• Symptoms lasted for the last 6 months.
• Not referring beyond the knee.
• Mild to moderate pain in Numerical Pain Rating Scale and mild to moderate disability on Oswestry Disability Index

Exclusion Criteria:

• Spine Surgeries
• Chronic diseases
• Accidents and Fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feldenkrais Method balance exercises; Balance exercises in Feldenkrais method plus core stability exercises	Other: Feldenkrais Method and Core stabilization; Balance exercises from supine lying position using Feldenkrais style, plus core stabilization exercises.
Active Comparator: Core stability exercises only; Core strengthening exercises to engage global and local stabilizers of the spinal column as Bridging exercises, Side bridging exercise, plank, side plank, McGill Abdominal exercises. Each exercise will be repeated for 3 sets with 8 repetitions with hold for 5 seconds.	Other: Core stability exercises; trunk deep muscles activation and engaging using exercises as bridging, side bridging, plank, side plank and McGill Abdominal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Using Biodex Balance System 3 parameters will be assessed. Overall stability Mediolateral stability Anteroposterior stability	Baseline and 5 weeks.

Collaborators and Investigators

• Sponsor: Misr University for Science and Technology
• Investigators: Study Chair: Neveen A Abdelraouf, Professor, Cairo university faculty of physical therapy; Study Director: Aya A Khalil, Lecturer, Cairo university faculty of physical therapy; Study Director: Shereen M Said, Lecturer, Misr University for Science and Technology; Principal Investigator: Mohamed E Fahmy, Instructor, Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): May 14, 2025
• Study Completion (Estimated): May 28, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: balance; mechanical low back pain; Feldenkrais method
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/005554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol will be shared by the principal investigator using email address mohamed.khater@must.edu.eg upon request.
• IPD Sharing Time Frame: After the date of publication of this work by 3 months.
• IPD Sharing Access Criteria: The requests will be assessed by the principal investigator. The data will be sent by the formal email address.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No