Mechanical Low Back PainNCT06756516
Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain
A study testing Feldenkrais Method and Core stabilization and Core stability exercises in people with Mechanical Low Back Pain, run by Misr University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Feldenkrais Method and Core stabilization and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2024to 28 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Spine Surgeries
- Chronic diseases
- Accidents and Fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Misr University for Science and Technology
Giza, 12582
Shaimaa N AboElazm, Dean, +201001779151, shaimaa.nabil@must.edu.eg
Mohamed E Fahmy, Instructor
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Feldenkrais Method and Core stabilization, Core stability exercises
- Keywords
- Feldenkrais method, mechanical low back pain, balance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais Method and Core stabilizationOther
Balance exercises from supine lying position using Feldenkrais style, plus core stabilization exercises.
Core stability exercisesOther
trunk deep muscles activation and engaging using exercises as bridging, side bridging, plank, side plank and McGill Abdominal
| Study group | Role | What they receive |
|---|---|---|
| Feldenkrais Method balance exercises | Experimental | Balance exercises in Feldenkrais method plus core stability exercises Receives: 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. Receives: Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Using Biodex Balance System 3 parameters will be assessed. Overall stability Mediolateral stability Anteroposterior stability
Measured: Baseline and 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start27 Nov 2024
- Primary completion14 May 2025 (estimated)
- Study completion28 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Emad Fahmy Mohamed, Misr University for Science and Technology
- Investigators
- Neveen A Abdelraouf, Professor, Study chair, Cairo University Faculty of Physical TherapyAya A Khalil, Lecturer, Study director, Cairo University Faculty of Physical TherapyShereen M Said, Lecturer, Study director, Misr University for Science and TechnologyMohamed E Fahmy, Instructor, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756516
- Sponsor's protocol ID
- P.T.REC/012/005554
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be shared by the principal investigator using email address mohamed.khater@must.edu.eg upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06756516
- Acronym / sponsor ID
- P.T.REC/012/005554
- Conditions
- Mechanical Low Back Pain
- Keywords
- Feldenkrais method, mechanical low back pain, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 14 May 2025 (estimated)
- Study completion
- 28 May 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feldenkrais Method balance exercises | Experimental | Other: Feldenkrais Method and Core stabilizationBalance exercises in Feldenkrais method plus core stability exercises |
| Core stability exercises only | Active comparator | Other: Core stability exercisesCore 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Spine Surgeries
- Chronic diseases
- Accidents and Fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feldenkrais Method and Core stabilizationBalance exercises from supine lying position using Feldenkrais style, plus core stabilization exercises. | Other | Feldenkrais Method balance exercises |
| Core stability exercisestrunk deep muscles activation and engaging using exercises as bridging, side bridging, plank, side plank and McGill Abdominal | Other | Core stability exercises only |
Primary outcome
Balance
Time frame: Baseline and 5 weeks.
Using Biodex Balance System 3 parameters will be assessed. Overall stability Mediolateral stability Anteroposterior stability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Yes. Study protocol will be shared by the principal investigator using email address mohamed.khater@must.edu.eg upon request.
Related trials for Mechanical Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neveen A Abdelraouf, Professor study chair
Cairo University Faculty of Physical Therapy
Aya A Khalil, Lecturer study director
Cairo University Faculty of Physical Therapy
Shereen M Said, Lecturer study director
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feldenkrais Method and Core stabilization and Core stability exercises in people with Mechanical Low Back Pain, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Fahmy, Instructor (+201114650668, mohamed.khater@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline and 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.