Women With Chronic Low Back PainNCT05533879
The Effect of Yoga on Body Awareness and Kinesiophobia in Women With Chronic Low Back Pain
A study testing Tele-yoga in people with Women With Chronic Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain (CLBP) is the most common problem in the musculoskeletal system and causes disability. The prevalence of chronic low back pain is 80% in women. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Women With Chronic Low Back Pain
- What is being tested?
- Tele-yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 3 Mar 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having received a minimum of 17 points from the kinesiophobia questionnaire
- Being between the ages of 25 and 65 and being a woman
- Having a complaint of low back pain for at least 6 months
- Not having cognitive, cognitive and mental problems
Who cannot join
- Having had surgery involving the spine.
- Being involved in any yoga group for the last 6 months
- Actively exercising regularly
- A previous or existing neurological disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul, 34662
tuba kolaylı, M.Sc., 05413698977, tubakolayli@gmail.com
About this study
Chronic low back pain (CLBP) is the most common problem in the musculoskeletal system and causes disability. The prevalence of chronic low back pain is 80% in women. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. The consequences of chronic low back pain include musculoskeletal problems, decreased sleep quality, decreased quality of life and limitation in activities of daily living, depression, anxiety, and decreased body awareness and kinesiophobia.
Kinesiophobia is defined as the fear of re-injury gained after injury, which reduces physical movement and activity. Patients with kinesiophobia develop the idea that movement will cause re-injury and add to pain. This situation leads to avoidance of physical activity and functional disability in the long term.
Read more
Body awareness, on the other hand, is the awareness of the messages that the brain receives from other parts of the body and from the outside. These messages that the person receives include not only his own body and movements, but also information such as the characteristics and locations of other objects in the environment. This information is blended over time and turns into experiences of the body.
Today, a rehabilitation method consisting of exercise programs, in which the active participation of the individual is ensured, is recommended, especially in the treatment approach to chronic low back pain. Within the scope of physiotherapy programs; heat applications and other physical therapy agents, exercise applications are recommended. Yoga is an alternative exercise practiced in CLBP as a body-mind exercise. Yoga is an easy-to-apply, non-invasive, cost-effective, scientifically proven practice.
Read the detailed description
Chronic low back pain (CLBP) is a very important problem that affects many people in the world and has a negative impact on the economy. The prevalence of chronic low back pain is 80% in women and 70% in men. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. Low back pain is classified as acute low back pain if it lasts for six weeks, subacute low back pain between six weeks and three months, and chronic low back pain if it lasts for more than three months.
CLBP is a complex problem that persists for a long time without a cause and is the most common in the musculoskeletal system and causes disability. Although low back pain is seen more frequently in women, its distribution varies according to gender when different etiologies are examined. Among the consequences of chronic low back pain are depression, anxiety, anxiety disorder, loss of muscle flexibility and power losses, joint disc degenerations, circulation problems, musculoskeletal system problems, decrease in sleep quality, decrease in quality of life and limitation in daily living activities, along with the pain-spasm cycle. decreased body awareness and kinesiophobia.
Kinesiophobia is defined as an excessive fear of re-injury that can be gained after a painful injury and reduces physical movement and activity. Patients with kinesiophobia develop the idea that movement will cause re-injury and add to pain. This leads to avoidance of physical activity in the long term, functional disability, depression and a decrease in quality of life.
Body awareness is a special form of consciousness. In neuroscience, body awareness is the brain's awareness of messages it receives from other parts of the body and from the outside. These messages that the person receives include not only his own body and movements, but also information such as the characteristics and locations of other objects in the environment. This information is blended over time and turns into experiences of the body.
Today, a rehabilitation method consisting of intense exercise programs, in which the active participation of the individual is ensured, is recommended instead of the passive treatment method, especially in the treatment approach to the individual with chronic low back pain. Early mobilization and exercise have been found to be beneficial in individuals with low back pain. Different physiotherapy programs are recommended for individuals with CLBP. Within the scope of physiotherapy programs; heat applications and other physical therapy agents, exercise applications are recommended. Exercise applications are especially recommended for low back pain.
Yoga is an alternative exercise applied in CLBP as a body-mind exercise. It has been reported that yoga has been used frequently in recent years because it provides core-stabilization, increases flexibility and balance, and controls pain with relaxation exercises.
Yoga is an easy-to-apply, non-invasive, low-cost, scientifically proven practice, and with the holistic well-being it brings, it promises hope for both physical and mental illnesses. When the literature is examined, there are studies that include the effects of yoga on quality of life, sleep quality, pain intensity, functional status, balance in people with chronic low back pain.
- Conditions
- Women With Chronic Low Back Pain
- Being tested
- Tele-yoga
- Keywords
- yoga, chronic low back pain, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-yogaOther
Women with chronic low back pain will be taken to group-based Tele-Yoga sessions of 60 minutes three times a week for 4 weeks, in an internet-based telerehabilitation environment.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Women with having received a minimum of 17 points from the kinesiophobia questionnaire, have chronic low back pain and aged between 25-65 Receives: Other: Tele-yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information form
This form was prepared by the researchers to obtain the demographic data of the people participating in the study. In this form, information about the age, gender and occupation of the participants is recorded.
Measured: 10 minutes
Visual Analog Scale (VAS)
When Visual Analog Scale (VAS) is used, I have no pain at one end, very severe pain is written on the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: 2 minutes
Body Awareness Questionnaire
The questionnaire is based on people's ratings of the situations they feel about themselves. After reading each statement, the number 1 to 7 is marked in the space to the left of the statement, which is appropriate for the person who filled out the questionnaire. The most accurate answer is the experience of the person filling out the questionnaire.
Measured: 20 minutes
Tampa Kinesiophobia Scale
It is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. As a result of the survey, the person gets a total score between 17-68 according to the answers he/she gives. The higher the score the person gets on the scale, the higher the kinesiophobia.
shows that.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start5 Sep 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion3 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
- Investigators
- tuba kolaylı, MSc., Study director, Uskudar UniversityAleyna Yaren Bayrak, B.S., Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533879
- Sponsor's protocol ID
- 61351342
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Body Awareness and Kinesiophobia in Women With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05533879
- Acronym / sponsor ID
- 61351342
- Conditions
- Women With Chronic Low Back Pain
- Keywords
- yoga, chronic low back pain, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 3 Mar 2023 (estimated)
- First posted
- 9 Sep 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.
Chronic low back pain (CLBP) is the most common problem in the musculoskeletal system and causes disability. The prevalence of chronic low back pain is 80% in women. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. The consequences of chronic low back pain include musculoskeletal problems, decreased sleep quality, decreased quality of life and limitation in activities of daily living, depression, anxiety, and decreased body awareness and kinesiophobia.
Kinesiophobia is defined as the fear of re-injury gained after injury, which reduces physical movement and activity. Patients with kinesiophobia develop the idea that movement will cause re-injury and add to pain. This situation leads to avoidance of physical activity and functional disability in the long term.
Body awareness, on the other hand, is the awareness of the messages that the brain receives from other parts of the body and from the outside. These messages that the person receives include not only his own body and movements, but also information such as the characteristics and locations of other objects in the environment. This information is blended over time and turns into experiences of the body.
Today, a rehabilitation method consisting of exercise programs, in which the active participation of the individual is ensured, is recommended, especially in the treatment approach to chronic low back pain. Within the scope of physiotherapy programs; heat applications and other physical therapy agents, exercise applications are recommended. Yoga is an alternative exercise practiced in CLBP as a body-mind exercise. Yoga is an easy-to-apply, non-invasive, cost-effective, scientifically proven practice.
Detailed description
Chronic low back pain (CLBP) is a very important problem that affects many people in the world and has a negative impact on the economy. The prevalence of chronic low back pain is 80% in women and 70% in men. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. Low back pain is classified as acute low back pain if it lasts for six weeks, subacute low back pain between six weeks and three months, and chronic low back pain if it lasts for more than three months.
CLBP is a complex problem that persists for a long time without a cause and is the most common in the musculoskeletal system and causes disability. Although low back pain is seen more frequently in women, its distribution varies according to gender when different etiologies are examined. Among the consequences of chronic low back pain are depression, anxiety, anxiety disorder, loss of muscle flexibility and power losses, joint disc degenerations, circulation problems, musculoskeletal system problems, decrease in sleep quality, decrease in quality of life and limitation in daily living activities, along with the pain-spasm cycle. decreased body awareness and kinesiophobia.
Kinesiophobia is defined as an excessive fear of re-injury that can be gained after a painful injury and reduces physical movement and activity. Patients with kinesiophobia develop the idea that movement will cause re-injury and add to pain. This leads to avoidance of physical activity in the long term, functional disability, depression and a decrease in quality of life.
Body awareness is a special form of consciousness. In neuroscience, body awareness is the brain's awareness of messages it receives from other parts of the body and from the outside. These messages that the person receives include not only his own body and movements, but also information such as the characteristics and locations of other objects in the environment. This information is blended over time and turns into experiences of the body.
Today, a rehabilitation method consisting of intense exercise programs, in which the active participation of the individual is ensured, is recommended instead of the passive treatment method, especially in the treatment approach to the individual with chronic low back pain. Early mobilization and exercise have been found to be beneficial in individuals with low back pain. Different physiotherapy programs are recommended for individuals with CLBP. Within the scope of physiotherapy programs; heat applications and other physical therapy agents, exercise applications are recommended. Exercise applications are especially recommended for low back pain.
Yoga is an alternative exercise applied in CLBP as a body-mind exercise. It has been reported that yoga has been used frequently in recent years because it provides core-stabilization, increases flexibility and balance, and controls pain with relaxation exercises.
Yoga is an easy-to-apply, non-invasive, low-cost, scientifically proven practice, and with the holistic well-being it brings, it promises hope for both physical and mental illnesses. When the literature is examined, there are studies that include the effects of yoga on quality of life, sleep quality, pain intensity, functional status, balance in people with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: Tele-yogaWomen with having received a minimum of 17 points from the kinesiophobia questionnaire, have chronic low back pain and aged between 25-65 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having received a minimum of 17 points from the kinesiophobia questionnaire
- Being between the ages of 25 and 65 and being a woman
- Having a complaint of low back pain for at least 6 months
- Not having cognitive, cognitive and mental problems
Key exclusion criteria (4 listed)
- Having had surgery involving the spine.
- Being involved in any yoga group for the last 6 months
- Actively exercising regularly
- A previous or existing neurological disorder
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 |
|---|---|---|
| Tele-yogaWomen with chronic low back pain will be taken to group-based Tele-Yoga sessions of 60 minutes three times a week for 4 weeks, in an internet-based telerehabilitation environment. | Other | Yoga group |
Primary outcome
Demographic information form
Time frame: 10 minutes
This form was prepared by the researchers to obtain the demographic data of the people participating in the study. In this form, information about the age, gender and occupation of the participants is recorded.
Visual Analog Scale (VAS)
Time frame: 2 minutes
When Visual Analog Scale (VAS) is used, I have no pain at one end, very severe pain is written on the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Body Awareness Questionnaire
Time frame: 20 minutes
The questionnaire is based on people's ratings of the situations they feel about themselves. After reading each statement, the number 1 to 7 is marked in the space to the left of the statement, which is appropriate for the person who filled out the questionnaire. The most accurate answer is the experience of the person filling out the questionnaire.
Tampa Kinesiophobia Scale
Time frame: 20 minutes
It is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. As a result of the survey, the person gets a total score between 17-68 according to the answers he/she gives. The higher the score the person gets on the scale, the higher the kinesiophobia. shows that.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
tuba kolaylı, MSc. study director
Uskudar University
Aleyna Yaren Bayrak, B.S. principal investigator
Uskudar 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 Tele-yoga in people with Women With Chronic Low Back Pain, run by Uskudar 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 4 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 9 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleyna Yaren Bayrak, B.S. (05305546198, bayrakaleynayaren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic information form (time frame: 10 minutes). 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 9 Sep 2022.