Chronic Non-Specific Low Back PainNCT04734314
Efficacy of Vojta on Balance and Quality of Life in Subject With CNLBP
A study testing conventional physical therapy and vojta therapy in people with Chronic Non-Specific Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
. To investigate the effect of Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-Specific Low Back Pain
- What is being tested?
- conventional physical therapy and vojta therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 5 Feb 2021
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with chronic non -specific low back pain for more than 3 months.
- Their age ranged between 18-35 years old
- Both sexes were recruited in this study.
- Their BMI ranged between 18-25 kg/m2
Who cannot join
- 1- Patients with previous spinal surgery 2. Patients who have radiological diagnosis of spondylolysis or spondylolisthesis.
- 3. Patient with neurological disease . 4. Chest problems 5. Systematic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vojta on Balance and Quality of Life in Subject With Chronic Non-spacific Low Back Pain
. To investigate the effect of Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain
Read the detailed description
This randomized controlled trial is to investigate the effect of Vojta method on balance and quality of life in patients with chronic non-specific low back pain.
Forty patients (male and female) complaining of chronic non -specific low back pain was recruited to share in this study
. The recruited patients were randomly recruited into two groups; group A (control group) and group B (study group).
Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks Group B: received conventional treatment of back pain in addition to Vojta method. The total treatment session is 40 min.
Patient in both groups performed 10 sessions, 3 session per week
- Conditions
- Chronic Non-Specific Low Back Pain
- Being tested
- conventional physical therapy, vojta therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
conventional physical therapy in the form of transcutaneous electrical stimulation (TENS) for 20 min and hot pack for 10 min Each patient received 12 sessions three session per week.
vojta therapyOther
Vojta Dynamic Neuromuscular Stabilization (DNS) is a therapy used to manage neurological and musculoskeletal conditions each patient in the study group (group B) was instructed to lie prone on an examination table with the participant's shoulders abducted, elbows flexed approximately 80-90°, and the forearms hanging off the edge of the table. Pressure-like stimulation of the calcaneus and ASIS were performed in the postural position named by Vojta as "reflex creeping.
Each patient received 12 sessions three session per week.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment of back pain | Experimental | Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks Receives: Other: conventional physical therapy |
| vojta therapy | Experimental | received conventional treatment of back pain in addition to Vojta therapy . The total treatment session is 40 min. Receives: Other: conventional physical therapy; Other: vojta therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
static and dynamic balance
static and dynamic balance can assessed by using biodex balance system Each patient was instructed to maintain his/her balance for the period of the test.
There was report gained after finishing every test includes information on medial lateral stability index(MLSI), overall stability index(OSI), and anterior posterior stability index (APSI) measurements will done twice before and after treatment for all patients in both group
Measured: one month
Oswestry Low Back Pain Disability Questionnaire
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability and quality of life. The test is considered the 'gold standard' of low back functional outcome tools measurements will done twice before and after treatment for all patients in both group
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2020
- Primary completion5 Feb 2021 (estimated)
- Study completion5 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734314
- Sponsor's protocol ID
- mtiu
- Status last verified
- Apr 2020
- First submitted
- 28 Jan 2021
- Last updated
- 8 Feb 2021
- 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 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vojta on Balance and Quality of Life in Subject With Chronic Non-spacific Low Back Pain
- ClinicalTrials.gov ID
- NCT04734314
- Acronym / sponsor ID
- mtiu
- Conditions
- Chronic Non-Specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 5 Feb 2021 (estimated)
- Study completion
- 5 Feb 2021 (estimated)
- First posted
- 2 Feb 2021 (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 Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain
Detailed description
This randomized controlled trial is to investigate the effect of Vojta method on balance and quality of life in patients with chronic non-specific low back pain.
Forty patients (male and female) complaining of chronic non -specific low back pain was recruited to share in this study
. The recruited patients were randomly recruited into two groups; group A (control group) and group B (study group).
Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks Group B: received conventional treatment of back pain in addition to Vojta method. The total treatment session is 40 min.
Patient in both groups performed 10 sessions, 3 session per week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment of back pain | Experimental | Other: conventional physical therapyGroup A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks |
| vojta therapy | Experimental | Other: conventional physical therapy, Other: vojta therapyreceived conventional treatment of back pain in addition to Vojta therapy . The total treatment session is 40 min. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with chronic non -specific low back pain for more than 3 months.
- Their age ranged between 18-35 years old
- Both sexes were recruited in this study.
- Their BMI ranged between 18-25 kg/m2
Key exclusion criteria (2 listed)
- 1- Patients with previous spinal surgery 2. Patients who have radiological diagnosis of spondylolysis or spondylolisthesis.
- 3. Patient with neurological disease . 4. Chest problems 5. Systematic disease
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 physical therapyconventional physical therapy in the form of transcutaneous electrical stimulation (TENS) for 20 min and hot pack for 10 min Each patient received 12 sessions three session per week. | Other | conventional treatment of back pain, vojta therapy |
| vojta therapyVojta Dynamic Neuromuscular Stabilization (DNS) is a therapy used to manage neurological and musculoskeletal conditions each patient in the study group (group B) was instructed to lie prone on an examination table with the participant's shoulders abducted, elbows flexed approximately 80-90°, and the forearms hanging off the edge of the table. Pressure-like stimulation of the calcaneus and ASIS were performed in the postural position named by Vojta as "reflex creeping. Each patient received 12 sessions three session per week. | Other | vojta therapy |
Primary outcome
static and dynamic balance
Time frame: one month
static and dynamic balance can assessed by using biodex balance system Each patient was instructed to maintain his/her balance for the period of the test. There was report gained after finishing every test includes information on medial lateral stability index(MLSI), overall stability index(OSI), and anterior posterior stability index (APSI) measurements will done twice before and after treatment for all patients in both group
Oswestry Low Back Pain Disability Questionnaire
Time frame: one month
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability and quality of life. The test is considered the 'gold standard' of low back functional outcome tools measurements will done twice before and after treatment for all patients in both group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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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 conventional physical therapy and vojta therapy in people with Chronic 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 2 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 8 Feb 2021. 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 walaa mohamed, B.Sc (01115640229, dr-walaamohamed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static and dynamic balance (time frame: one month). 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 8 Feb 2021.