Non Specific Low Back PainNCT05953922
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
A study testing core stability exersises in people with Non Specific Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect… Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- core stability exersises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Sep 2023
- 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 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gender is women
- age ranges from 22 to45 years old
- chronic non specific low back pain for at least 3 month
- pain score will between 3 to 6 on visual analogue scale
Who cannot join
- Any deformity of the spine
- Red flags including serious pathology
- Systemic or inflammatory disease
- sever osteoporosis
- history of tumor or cancer
- spine infection
Show all 14Show fewer
- history of spine or pelvis surgery or fracture
- cauda equina syndrome
- progressive neurological deficit
- severe instability
- sever cardio vascular or metabolic disease
- history of psychological disease
- anatomical and congenital disturbance
- continuous pain more than 8 on (visual analogue scale)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Cairo
About this study
Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain.
Read the detailed description
The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain
This study is delimited to the following aspects:
- Fifty, patients of only females with chronic non specific low back pain more than 3 months.
- The age will range from 22 to 45 years.
- The treatment will conduct to three session per week for four weeks .
- The selected patients will assigned randomly to two equal groups:
1- Group1 (intervention), will do the selected treatment that include electrical stimulation in addition to Core stability exercises program. 2- Group2(control), will do the conventional treatment only.
- Conditions
- Non Specific Low Back Pain
- Being tested
- core stability exersises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability exersisesOther
Also called transcutaneous electrical nerve stimulation
core stability exercises and transcutaneous electrical nerve stimulation for four week three session per week
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | The treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks. Receives: Other: core stability exersises |
| control group | No intervention | The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life for each participants
We will use the Arabic version of world health organization's quality of life (Arabic_WHOQOL-BREF) questionnaire and higher score means better outcome
Measured: baseline
pain levels for each participants
visual analogue scale will be used to assess the level of pain and higher score means worse outcome
Measured: baseline
pressure lumber biofeedback for each participants
pressure lumber biofeedback for asses transverse abdominis contraction
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Oct 2022
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific 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
- intervention study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Ahmed Salama Ashour, Cairo University
- Investigators
- EMAN M. FAYEZ, Professor, Study chair, Physical Therapy for Neuromuscular Disorder and Its SurgeryHossam M. Alsaid, Lecturer, Study chair, Physical Therapy for Neuromuscular Disorder and Its SurgeryMARIHAN Z. Aziz, Lecturer, Study chair, Physical Therapy for Musculoskeletal Disorders and its Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953922
- Sponsor's protocol ID
- non specific low back pain
- Status last verified
- Jul 2023
- First submitted
- 7 May 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05953922
- Acronym / sponsor ID
- non specific low back pain
- Conditions
- Non Specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 20 Jul 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.
Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain.
Detailed description
The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain
This study is delimited to the following aspects:
- Fifty, patients of only females with chronic non specific low back pain more than 3 months.
- The age will range from 22 to 45 years.
- The treatment will conduct to three session per week for four weeks .
- The selected patients will assigned randomly to two equal groups:
1- Group1 (intervention), will do the selected treatment that include electrical stimulation in addition to Core stability exercises program. 2- Group2(control), will do the conventional treatment only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intervention study
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Other: core stability exersisesThe treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks. |
| control group | No intervention | –The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- gender is women
- age ranges from 22 to45 years old
- chronic non specific low back pain for at least 3 month
- pain score will between 3 to 6 on visual analogue scale
Key exclusion criteria (14 listed)
- Any deformity of the spine
- Red flags including serious pathology
- Systemic or inflammatory disease
- sever osteoporosis
- history of tumor or cancer
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 exersisesAlso: transcutaneous electrical nerve stimulationcore stability exercises and transcutaneous electrical nerve stimulation for four week three session per week | Other | treatment group |
Primary outcome
quality of life for each participants
Time frame: baseline
We will use the Arabic version of world health organization's quality of life (Arabic_WHOQOL-BREF) questionnaire and higher score means better outcome
pain levels for each participants
Time frame: baseline
visual analogue scale will be used to assess the level of pain and higher score means worse outcome
pressure lumber biofeedback for each participants
Time frame: baseline
pressure lumber biofeedback for asses transverse abdominis contraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Chronic Non Specific Mechanical Low Back Pain
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific 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. This study is not recruiting at the moment.
EMAN M. FAYEZ, Professor study chair
Physical Therapy for Neuromuscular Disorder and Its Surgery
Hossam M. Alsaid, Lecturer study chair
Physical Therapy for Neuromuscular Disorder and Its Surgery
MARIHAN Z. Aziz, Lecturer study chair
Physical Therapy for Musculoskeletal Disorders and its Surgery
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 exersises in people with Non Specific 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 14 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 20 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa A. Salama Ashour, Bachelor's (01008983388, pt.w.ahmedashour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life for each participants (time frame: baseline). The study lists 3 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 20 Jul 2023.