Low Back Pain, MechanicalNCT05948189
Low Back Health Education on Physical Function and Body Awareness in Academicians
A study testing exercise program in people with Low Back Pain, Mechanical, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The participants of the intervention group received back health education (Back School) in the classroom. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Oct 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Taking part in full-time academic staff at Ondokuz Mayıs University and Samsun University in Turkey.
- To continue his/her career at the university for at least 3 years without break
- Male and female volunteer academicians between the ages of 25-65
Who cannot join
- Those with any identified back pain problem
- Those who have undergone spinal surgery
- Those with neurological problems
- Those with orthopedic problems
- Those with cardiac or pulmonary problems (except controlled taking by medicines.
- Part-time employees
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, Zeytinburnu, 34010
About this study
Official title: Investigation of the Effect of Low Back Health Education on Physical Function and Body Awareness in Academicians: Randomized Controlled Study
This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.
Read the detailed description
This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The study was completed with a total of 94 (49 female and 45 male) volunteer academicians (intervention group n=47, control group n=47) between the ages of 25-65, with a mean age of 43.22±10.924 years. The participants of both groups were evaluated before and after the 6-week education and training. In order to evaluate physical functions of the participants, One Leg Standing Test (eyes open and closed), Half Squat Test, Curl-Up Test, and Sit and Reach Test were used. The Body Awareness Questionnaire (BAQ) was used to assess body awareness of the sample. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- exercise program
- Keywords
- Academician, physical function, body awareness, low back health, back school
- 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.
exercise programOther
The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | a 6-week exercise program Receives: Other: exercise program |
| Controls | No intervention | a brochure to read |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Leg Standing Test (eyes open and closed)
One Leg Standing Test (eyes open and closed)
Measured: through study completion, an average of 1 year
Half Squat Test
performed half squats
Measured: through study completion, an average of 1 year
Curl-Up Test
performed curl-up
Measured: through study completion, an average of 1 year
Sit and Reach Test
participants asked to reach forward on the test table in long sitting position on the mat.
Measured: through study completion, an average of 1 year
Body Awareness Questionnaire (BAQ)
all the participants filled out the questionaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 Jun 2023
- Primary completion1 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 94 (49 female and 45 male) volunteer academicians divided into two groups:intervention group (n=47) and control group (n=47), randomly.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
- Investigators
- UGUR CAVLAK, Prof., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948189
- Sponsor's protocol ID
- 2022/73-06
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Publications
Banerjee S, Argaez C. Multidisciplinary Treatment Programs for Patients with Acute or Subacute Pain: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 May 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK546002/
PubMed 31498579Cortell-Tormo JM, Sanchez PT, Chulvi-Medrano I, Tortosa-Martinez J, Manchado-Lopez C, Llana-Belloch S, Perez-Soriano P. Effects of functional resistance training on fitness and quality of life in females with chronic nonspecific low-back pain. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):95-105. doi: 10.3233/BMR-169684.
PubMed 28826168Park HK, Song MK, Kim DJ, Choi IS, Han JY. Comparison of core muscle strengthening exercise and stretching exercise in middle-aged women with fibromyalgia: A randomized, single-blind, controlled study. Medicine (Baltimore). 2021 Dec 17;100(50):e27854. doi: 10.1097/MD.0000000000027854.
PubMed 34918634
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Low Back Health Education on Physical Function and Body Awareness in Academicians: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05948189
- Acronym / sponsor ID
- 2022/73-06
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Academician, physical function, body awareness, low back health, back school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 17 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.
This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.
Detailed description
This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The study was completed with a total of 94 (49 female and 45 male) volunteer academicians (intervention group n=47, control group n=47) between the ages of 25-65, with a mean age of 43.22±10.924 years. The participants of both groups were evaluated before and after the 6-week education and training. In order to evaluate physical functions of the participants, One Leg Standing Test (eyes open and closed), Half Squat Test, Curl-Up Test, and Sit and Reach Test were used. The Body Awareness Questionnaire (BAQ) was used to assess body awareness of the sample. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 94 (49 female and 45 male) volunteer academicians divided into two groups:intervention group (n=47) and control group (n=47), randomly.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: exercise programa 6-week exercise program |
| Controls | No intervention | –a brochure to read |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Taking part in full-time academic staff at Ondokuz Mayıs University and Samsun University in Turkey.
- To continue his/her career at the university for at least 3 years without break
- Male and female volunteer academicians between the ages of 25-65
Key exclusion criteria (6 listed)
- Those with any identified back pain problem
- Those who have undergone spinal surgery
- Those with neurological problems
- Those with orthopedic problems
- Those with cardiac or pulmonary problems (except controlled taking by medicines.
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 |
|---|---|---|
| exercise programThe participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). | Other | intervention group |
Primary outcome
One Leg Standing Test (eyes open and closed)
Time frame: through study completion, an average of 1 year
One Leg Standing Test (eyes open and closed)
Half Squat Test
Time frame: through study completion, an average of 1 year
performed half squats
Curl-Up Test
Time frame: through study completion, an average of 1 year
performed curl-up
Sit and Reach Test
Time frame: through study completion, an average of 1 year
participants asked to reach forward on the test table in long sitting position on the mat.
Body Awareness Questionnaire (BAQ)
Time frame: through study completion, an average of 1 year
all the participants filled out the questionaire
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 13 Feb 2024.
- Results publication: PubMed 31498579Banerjee S, Argaez C. Multidisciplinary Treatment Programs for Patients with Acute or Subacute Pain: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 May 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK546002/
- Results publication: PubMed 28826168Cortell-Tormo JM, Sanchez PT, Chulvi-Medrano I, Tortosa-Martinez J, Manchado-Lopez C, Llana-Belloch S, Perez-Soriano P. Effects of functional resistance training on fitness and quality of life in females with chronic nonspecific low-back pain. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):95-105. doi: 10.3233/BMR-169684.
- Results publication: PubMed 34918634Park HK, Song MK, Kim DJ, Choi IS, Han JY. Comparison of core muscle strengthening exercise and stretching exercise in middle-aged women with fibromyalgia: A randomized, single-blind, controlled study. Medicine (Baltimore). 2021 Dec 17;100(50):e27854. doi: 10.1097/MD.0000000000027854.
- Individual participant dataSharing planned: Yes. Yes
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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.
UGUR CAVLAK, Prof. principal investigator
Biruni 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 exercise program in people with Low Back Pain, Mechanical, run by Biruni University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Turkey (Türkiye). 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?
One Leg Standing Test (eyes open and closed) (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 NCT05948189, which also lists 3 linked publications.
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 13 Feb 2024.