Low Back PainNCT06182826
Effect of Core Engagement Exercises and Routine Exercise Therapy on Low Back Pain in Middle School Children
A study testing Core Stability protocol and Routine exercise therapy in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Low back pain is defined as the region of pain between the lower ribs and hips. Low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core Stability protocol and Routine exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2023to 1 Feb 2024
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Middle aged school children between age 9 and 14.
- Both male and female.
- Back pain of 2 or greater on NPRS
Who cannot join
- Structural observational deformity (kyposis, lordosis, scoliosis)
- History of post spinal surgery
- Acute low back pain flare up
- Pain or any other injury of lower limbs
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Muhammad Ehab, DPT,MSNMPT,phd, 03155330080, ehab@fui.edu.pk
About this study
Low back pain is defined as the region of pain between the lower ribs and hips. Low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. Poor posture, prolonged sitting and lack of physical activity results in back pain that leads to poor performance in school as well as attendance.
Read the detailed description
Middle school children are the children of the age where they spend most of their hours sitting in school. Low back pain often goes undiagnosed and unreported in children which persists and if left untreated, causes problems in later stages in life.
Low back pain is the region of pain from lower ribs to hips. Children and teenagers often have lower back discomfort, which may be brought on by several conditions, including poor lifting skills, bad posture, and overuse injuries from sports or other physical activity. According to estimates, up to 50% of school-aged children may sometimes have lower back discomfort. The muscles that surround our spine are considered the "core" of our body. It is composed of the abdominal muscles on your front and sides, the erector muscles and gluteus. Each and every one of these muscles must work together in order to enhance the stability of the spine. When muscles contract they create force and stiffness. It is the stiffness part that is important for stability. When the core fails to meet the stability demands placed on the body during a certain lift, parts of the spine will be overloaded with forces that increase injury risk and performance will suffer. For that, various warm up exercises, stretches and mobility exercises are performed so that the body can work as stable linked system that works efficiently as well.
- Conditions
- Low Back Pain
- Being tested
- Core Stability protocol, Routine exercise therapy
- 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.
Core Stability protocolProcedure or surgery
5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Curl Up Side Planks Bird Dog Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes
Routine exercise therapyProcedure or surgery
5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in this group will receive Core Stability Protocol with Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given. Receives: Procedure: Core Stability protocol; Procedure: Routine exercise therapy |
| Group B | Active comparator | Patients will receive Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given. Receives: Procedure: Routine exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.
Measured: 6 week
Trunk Extensor Endurance
Trunk extensor endurance will be measured using McGill Endurance Test Battery
Measured: 6 week
Trunk Flexor Endurance
Trunk flexor endurance will be measured using McGill Endurance Test Battery
Measured: 06 Week
Lateral Endurance
Trunk lateral endurance will be measured using McGill Endurance Test Battery
Measured: 06 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start30 Aug 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- This is a single blinded randomized controlled trial having two groups. One group will be given Core Stabilization Protocol along with Routine exercise therapy whereas other group will only receive Routine Exercise therapy protocol. Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182826
- Sponsor's protocol ID
- FUI/CTR/2023/24
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Engagement Exercises and Routine Exercise Therapy on Low Back Pain in Middle School Children
- ClinicalTrials.gov ID
- NCT06182826
- Acronym / sponsor ID
- FUI/CTR/2023/24
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Dec 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.
Low back pain is defined as the region of pain between the lower ribs and hips. Low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. Poor posture, prolonged sitting and lack of physical activity results in back pain that leads to poor performance in school as well as attendance.
Detailed description
Middle school children are the children of the age where they spend most of their hours sitting in school. Low back pain often goes undiagnosed and unreported in children which persists and if left untreated, causes problems in later stages in life.
Low back pain is the region of pain from lower ribs to hips. Children and teenagers often have lower back discomfort, which may be brought on by several conditions, including poor lifting skills, bad posture, and overuse injuries from sports or other physical activity. According to estimates, up to 50% of school-aged children may sometimes have lower back discomfort. The muscles that surround our spine are considered the "core" of our body. It is composed of the abdominal muscles on your front and sides, the erector muscles and gluteus. Each and every one of these muscles must work together in order to enhance the stability of the spine. When muscles contract they create force and stiffness. It is the stiffness part that is important for stability. When the core fails to meet the stability demands placed on the body during a certain lift, parts of the spine will be overloaded with forces that increase injury risk and performance will suffer. For that, various warm up exercises, stretches and mobility exercises are performed so that the body can work as stable linked system that works efficiently as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single blinded randomized controlled trial having two groups. One group will be given Core Stabilization Protocol along with Routine exercise therapy whereas other group will only receive Routine Exercise therapy protocol. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Core Stability protocol, Procedure: Routine exercise therapyPatients in this group will receive Core Stability Protocol with Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given. |
| Group B | Active comparator | Procedure: Routine exercise therapyPatients will receive Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Middle aged school children between age 9 and 14.
- Both male and female.
- Back pain of 2 or greater on NPRS
Key exclusion criteria (4 listed)
- Structural observational deformity (kyposis, lordosis, scoliosis)
- History of post spinal surgery
- Acute low back pain flare up
- Pain or any other injury of lower limbs
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 |
|---|---|---|
| Core Stability protocol5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Curl Up Side Planks Bird Dog Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes | Procedure or surgery | Group A |
| Routine exercise therapy5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes | Procedure or surgery | Group A, Group B |
Primary outcome
Pain Intensity
Time frame: 6 week
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.
Trunk Extensor Endurance
Time frame: 6 week
Trunk extensor endurance will be measured using McGill Endurance Test Battery
Trunk Flexor Endurance
Time frame: 06 Week
Trunk flexor endurance will be measured using McGill Endurance Test Battery
Lateral Endurance
Time frame: 06 Week
Trunk lateral endurance will be measured using McGill Endurance Test Battery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stability protocol and Routine exercise therapy in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arshia Salman, MS-MSKPT* (03349590943, arshia.salman98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 week). The study lists 4 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 27 Dec 2023.