Mechanical Low Back PainNCT06009263
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
A study testing Conventional treatment in people with Mechanical Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Conventional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2023to 1 Sep 2026
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.
- Participants with chronic low back pain lasting for more than 6 Months.
- A patient who can follow the command.
- A patient who can do exercise.
Who cannot join
- Low back pain patients with a history of severe neurological disease or orthopedic disease.
- History of Psychological Disorder.
- Unhealthy Patient.
- Pregnant women.
- Patient with a spinal tumor.
- History of any operation related to spine. Ex. Vertebral fracture or dislocation.
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
Faculty of Physical Therapy
Giza, Dokki, 12612
Haytham M Elhafez, +201001909630, elhafez@yahoo.com
Mona E Hassan, Msc
About this study
Official title: Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain
To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.
Read the detailed description
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber ROM.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on CSA of multifidus muscle.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Conventional treatment, Open chain segmental control, Closed chain segmental control
- Keywords
- Mechanical LBP, Cross Sectional Area, Multifidus muscle
- 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.
Conventional treatmentOther
Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Open chain segmental controlOther
Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Closed chain segmental controlOther
Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | The participants will receive conventional treatment in the form of TENS and Ultrasound. Receives: Other: Conventional treatment |
| Intervention 1 | Experimental | The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound. Receives: Other: Open chain segmental control |
| Intervention 2 | Experimental | The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound. Receives: Other: Closed chain segmental control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area of multifidus muscle
Cross sectional area of multifidus muscle
Measured: Pre and Post measurement (12 weeks)
Pain intensity
Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
Measured: Pre and Post measurement (12 weeks)
Secondary outcomes (2)
ROM of lumbar spine
Measuring ROM of lumbar spine
Measured: Pre and Post measurement (12 weeks)
Functional ability of lumbar spine
Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)
Measured: Pre and Post measurement (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start2 Sep 2023
- Primary completion13 Jun 2026 (estimated)
- Study completion1 Sep 2026 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Group will receive ultrasound and TENS as conventional treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haytham M Elhafez, Cairo University
- Investigators
- Haytham M Elhafez, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009263
- Sponsor's protocol ID
- REC/007/002763
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06009263
- Acronym / sponsor ID
- REC/007/002763
- Conditions
- Mechanical Low Back Pain
- Keywords
- Mechanical LBP, Cross Sectional Area, Multifidus muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 13 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.
Detailed description
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber ROM.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on CSA of multifidus muscle.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Group will receive ultrasound and TENS as conventional treatment
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Conventional treatmentThe participants will receive conventional treatment in the form of TENS and Ultrasound. |
| Intervention 1 | Experimental | Other: Open chain segmental controlThe participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound. |
| Intervention 2 | Experimental | Other: Closed chain segmental controlThe participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.
- Participants with chronic low back pain lasting for more than 6 Months.
- A patient who can follow the command.
- A patient who can do exercise.
Key exclusion criteria (6 listed)
- Low back pain patients with a history of severe neurological disease or orthopedic disease.
- History of Psychological Disorder.
- Unhealthy Patient.
- Pregnant women.
- Patient with a spinal tumor.
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 |
|---|---|---|
| Conventional treatmentApplication of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain. | Other | Control |
| Open chain segmental controlApplication of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain. | Other | Intervention 1 |
| Closed chain segmental controlApplication of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain. | Other | Intervention 2 |
Primary outcome
Cross sectional area of multifidus muscle
Time frame: Pre and Post measurement (12 weeks)
Cross sectional area of multifidus muscle
Pain intensity
Time frame: Pre and Post measurement (12 weeks)
Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
2 secondary outcomes
ROM of lumbar spine
Time frame: Pre and Post measurement (12 weeks)
Functional ability of lumbar spine
Time frame: Pre and Post measurement (12 weeks)
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 18 May 2026.
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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.
Haytham M Elhafez, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment in people with Mechanical Low Back Pain, run by Cairo University 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 6 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 18 May 2026. 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. Some participants in this study may receive a placebo. 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 Haytham M Elhafez, PhD (+201001909630, elhafez@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional area of multifidus muscle (time frame: Pre and Post measurement (12 weeks)). The study lists 2 primary outcomes in all. 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 18 May 2026.