NCT06756516

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

November 27, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 23, 2024

Last Update Submit

December 31, 2024

Conditions

Keywords

Feldenkrais methodmechanical low back painbalance

Outcome Measures

Primary Outcomes (1)

  • Balance

    Using Biodex Balance System 3 parameters will be assessed. Overall stability Mediolateral stability Anteroposterior stability

    Baseline and 5 weeks.

Study Arms (2)

Feldenkrais Method balance exercises

EXPERIMENTAL

Balance exercises in Feldenkrais method plus core stability exercises

Other: Feldenkrais Method and Core stabilization

Core stability exercises only

ACTIVE COMPARATOR

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

Interventions

Balance exercises from supine lying position using Feldenkrais style, plus core stabilization exercises.

Feldenkrais Method balance exercises

trunk deep muscles activation and engaging using exercises as bridging, side bridging, plank, side plank and McGill Abdominal

Core stability exercises only

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Spine Surgeries
  • Chronic diseases
  • Accidents and Fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, 12582, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neveen A Abdelraouf, Professor

    Cairo University Faculty of Physical Therapy

    STUDY CHAIR
  • Aya A Khalil, Lecturer

    Cairo University Faculty of Physical Therapy

    STUDY DIRECTOR
  • Shereen M Said, Lecturer

    Misr University for Science and Technology

    STUDY DIRECTOR
  • Mohamed E Fahmy, Instructor

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed E Fahmy, Instructor

CONTACT

Aya A Khalil, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant Biomechanics department

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 3, 2025

Study Start

November 27, 2024

Primary Completion

May 14, 2025

Study Completion

May 28, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Study protocol will be shared by the principal investigator using email address mohamed.khater@must.edu.eg upon request.

Shared Documents
STUDY PROTOCOL
Time Frame
After the date of publication of this work by 3 months.
Access Criteria
The requests will be assessed by the principal investigator. The data will be sent by the formal email address.

Locations