Chronic Low-back PainNSLBPNCT05288946
Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain
A study testing traditional therapy in people with Chronic Low-back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2022to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients had NS LBP Patients with age from 20 to 40 years for both genders.
- The lumbar region of back pain lasts for 4 weeks \& more has not been diagnose as a specific disease or spinal abnormality.
- Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%).
- Shortening of hamstring.
- The study populations must be willing to participate in the study.
Who cannot join
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease.
- Psychiatric/mental deficit
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Segmental Control Program on Hamstring Peak Torque,Pain,Function and Range of Motion in Patients With Non-specific Low Back Pain
The purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain.
Read the detailed description
Low back pain (LBP) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.The reported prevalence of LBP was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group. Recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for LBP management. The approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine. Several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability. But also other core muscles are involved. so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain. forty-five patients will be allocated to three groups. first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment
- Conditions
- Chronic Low-back Pain
- Being tested
- local segmental control and closed kinetic chain, local segmental control and open kinetic chain, traditional therapy
- Keywords
- segmental stabilization exercise, low back pain, peak torque
- 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.
local segmental control and closed kinetic chainOther
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then closed kinetic chain exercise in the form of Stand-up position on unstable surface, Closed chain lunge exercises, with the addition of hand weights, Bridge in prone position, Bridge in supine position, Lateral Bridge
local segmental control and open kinetic chainOther
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then open kinetic chain in the form of Lower limb abduction, Knee extension in a supine position on a roller, Open chain exercise of the upper limb after co-contraction of transversus abdominis and multifidus.
traditional therapyOther
the patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors
| Study group | Role | What they receive |
|---|---|---|
| local segmental control and closed kinetic chain | Experimental | the patients will receive local segmental control and closed kinetic chain three times a week for four weeks Receives: Other: local segmental control and closed kinetic chain; Other: traditional therapy |
| local segmental control and open kinetic chain | Experimental | the patients will receive local segmental control and open kinetic chain three times a week for four weeks Receives: Other: local segmental control and open kinetic chain; Other: traditional therapy |
| traditional therapy | Active comparator | the patients will receive traditional therapy three times a week for four week Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak torque
isokinetic will be used for measuring hamstring peak torque
Measured: up to four weeks
Secondary outcomes (2)
pain intensity
visual analogue scale will be used for assessment of pain intensity
Measured: up to four weeks
disability
oswestry disability scale will be used for assessment of disability, Each patient was asked to answer by checking one box in each section for the statement which best applies to him. Then the marks had been counted and divided by 50 or 45.score ranging from 0 (no pain or disability) to 50 (severe pain and disability) . Then was multiplied by 100 for the percentage (score/ 50) x 100=% points. A score of 0% to 20% is minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled and 81%-100%: complete disability.
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start28 Mar 2022
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- segmental stabilization exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288946
- Sponsor's protocol ID
- p.t.REC/012/002673
- Acronym
- NSLBP
- Status last verified
- Oct 2022
- First submitted
- 11 Mar 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelazeim AS, Elhafez HM, Abdullah HH, Essa SA, Zahran MR. Effect of segmental control program on hamstring peak torque, pain and disability in patients with non-specific low back pain: A randomized controlled trial. J Bodyw Mov Ther. 2025 Oct;44:507-514. doi: 10.1016/j.jbmt.2025.06.014. Epub 2025 Jun 18.
PubMed 40954623
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Segmental Control Program on Hamstring Peak Torque,Pain,Function and Range of Motion in Patients With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05288946
- Acronym / sponsor ID
- NSLBP / p.t.REC/012/002673
- Conditions
- Chronic Low-back Pain
- Keywords
- segmental stabilization exercise, low back pain, peak torque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 21 Mar 2022 (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 purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain.
Detailed description
Low back pain (LBP) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.The reported prevalence of LBP was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group. Recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for LBP management. The approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine. Several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability. But also other core muscles are involved. so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain. forty-five patients will be allocated to three groups. first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- segmental stabilization exercises
| Arm | Type | Receives |
|---|---|---|
| local segmental control and closed kinetic chain | Experimental | Other: local segmental control and closed kinetic chain, Other: traditional therapythe patients will receive local segmental control and closed kinetic chain three times a week for four weeks |
| local segmental control and open kinetic chain | Experimental | Other: local segmental control and open kinetic chain, Other: traditional therapythe patients will receive local segmental control and open kinetic chain three times a week for four weeks |
| traditional therapy | Active comparator | Other: traditional therapythe patients will receive traditional therapy three times a week for four week |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients had NS LBP Patients with age from 20 to 40 years for both genders.
- The lumbar region of back pain lasts for 4 weeks \& more has not been diagnose as a specific disease or spinal abnormality.
- Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%).
- Shortening of hamstring.
- The study populations must be willing to participate in the study.
Key exclusion criteria (3 listed)
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease.
- Psychiatric/mental deficit
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
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 |
|---|---|---|
| local segmental control and closed kinetic chainthe patients will receive Lumbar multifidus activation and Transversus abdominis activation then closed kinetic chain exercise in the form of Stand-up position on unstable surface, Closed chain lunge exercises, with the addition of hand weights, Bridge in prone position, Bridge in supine position, Lateral Bridge | Other | local segmental control and closed kinetic chain |
| local segmental control and open kinetic chainthe patients will receive Lumbar multifidus activation and Transversus abdominis activation then open kinetic chain in the form of Lower limb abduction, Knee extension in a supine position on a roller, Open chain exercise of the upper limb after co-contraction of transversus abdominis and multifidus. | Other | local segmental control and open kinetic chain |
| traditional therapythe patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors | Other | local segmental control and closed kinetic chain, local segmental control and open kinetic chain, traditional therapy |
Primary outcome
peak torque
Time frame: up to four weeks
isokinetic will be used for measuring hamstring peak torque
2 secondary outcomes
pain intensity
Time frame: up to four weeks
disability
Time frame: up to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 40954623Abdelazeim AS, Elhafez HM, Abdullah HH, Essa SA, Zahran MR. Effect of segmental control program on hamstring peak torque, pain and disability in patients with non-specific low back pain: A randomized controlled trial. J Bodyw Mov Ther. 2025 Oct;44:507-514. doi: 10.1016/j.jbmt.2025.06.014. Epub 2025 Jun 18.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional therapy in people with Chronic 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 5 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: finished, as of the sponsor's last update on 31 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak torque (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288946, which also lists 1 linked publication.
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 31 Oct 2022.