Chronic Low-back PainNCT05080101
Effects of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life in Chronic Low Back Pain
A study testing Conventional Therapy Program and Basic Body Awareness Therapy Group Program in people with Chronic Low-back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain is a common problem worldwide. In treatment, conservative methods usually are used. Basic Body Awareness Therapy is related to mindfulness-based therapies and meditation techniques. It is a method that has been used and found effective in some diseases affecting the musculoskeletal system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Conventional Therapy Program and Basic Body Awareness Therapy Group Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 21 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having low back pain for 3 months or more
- Being between the ages of 18-65
- Not having received any back-related treatment before
- Volunteer to participate in the study
Who cannot join
- Pregnancy
- History of tumor / metastatic disease
- History of spinal trauma, spinal cord injury
- History of infection
- Presence of congenital deformity in the spine
- History of previous spinal surgery
Show all 9Show fewer
- Having a neurological disease (Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke)
- Having musculoskeletal problems other than low back pain (rheumatoid arthritis, pathological fractures, avascular necrosis or osteonecrosis, severe osteoarthritis, spondylo-arthropathy)
- Patients who received a physiotherapy rehabilitation program in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Sof Basic Body Awareness Therapy on Posture, Pain, Disability, Quality of Life, Sleep Quality and Body Awareness in Individual With Chronic Low Back Pain
Chronic low back pain is a common problem worldwide. In treatment, conservative methods usually are used. Basic Body Awareness Therapy is related to mindfulness-based therapies and meditation techniques. It is a method that has been used and found effective in some diseases affecting the musculoskeletal system. Therefore, in this study, body awareness was applied in addition to conventional treatment in patients with chronic low back pain.
Read the detailed description
Throughout a lifetime, chronic low back pain is a common problem that affects approximately 80% of people. Among musculoskeletal system problems, it is one of the most commonly observed issues. There are various treatment methods available. The absence of evidence-based treatment guidelines negatively affects the choice of treatment to be applied. There are medical and conservative treatment options. These methods include acupuncture, transcutaneous electrical nerve stimulation, injection therapy, non-steroidal anti-inflammatory drugs, and lumbar supports. Basic Body Awareness Therapy is a physiotherapy treatment method that has been developed in the Scandinavian countries over the course of the last two decades. This innovative approach focuses on enhancing body awareness and has gained recognition as an effective therapeutic technique in the field of physiotherapy. Basic Body Awareness Therapy has been applied as a secondary treatment method in various conditions such as fibromyalgia, neck pain, and ankylosing spondylitis, and has been found to be effective. It has yielded positive results when used in addition to conventional treatments for musculoskeletal problems, as demonstrated in the literature. This study aims to apply Basic Body Awareness Therapy to individuals with chronic low back pain, based on its effectiveness in musculoskeletal issues, and create a new treatment combination. Twenty-eight patients were included in the study, and in addition to the standard treatment protocol, Basic Body Awareness Therapy exercises were administered.
- Conditions
- Chronic Low-back Pain
- Being tested
- Conventional Therapy Program, Basic Body Awareness Therapy Group Program
- Keywords
- Pain, Quality of Life, Disability, Sleep, Body Awareness
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Therapy ProgramOther
Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head.
Basic Body Awareness Therapy Group ProgramOther
Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head. Receives: Other: Conventional Therapy Program |
| Basic Body Awareness Therapy Group | Experimental | Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance. Receives: Other: Basic Body Awareness Therapy Group Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Score
The Oswestry Disability Index (ODI) is the gold standard, valid and reliable outcome measurement tool for assessing functionality in patients with low back pain. For 10 different functional activities, there are 6 different answers for which the patient does not know the score equivalent. Each activity is scored between 0 (functional level adequate) and 5 (severe limitation). The measurement result is expressed over the total score and the ratio of the score to the total maximum score is determined as a percentage. 0-20% minimal disability, 21-40% moderate disability, 41-60% severe disability, 61-80% bedridden, 81-100% completely bedridden or interpreted as exaggerating their situation. The minimal clinical significance level is accepted as 10%, changes occurring less than this rate are considered as measurement error.
Measured: 5 mins
Functional Rating Index Score
The Functional Rating Index (FRI) is a valid and reliable method that evaluates the functionality and the decrease in functions caused by low back pain. FRI evaluates the functional level in 10 different domain (sleep, personal care, travel, work, etc.) that may be affected due to low back pain. FRI is a scale in which each item is scored between 0 (no pain, no restriction while doing the activity) and 4 (totally dependent, need someone else's help). Maximum score of FRI is 40 which indicates that the patient can easily perform functional activities.
Measured: 5 mins
New York Posture Analysis Score
The New York Posture Analysis (NYPA) will be used to assess patients' posture. NYPA consists of 13 items that evaluate the static posture of the body from the lateral and posterior aspects, and each item is given a score of five (5) if the person has a correct posture, three (3) if the posture is moderately impaired, and one (1) point if there is a severe deterioration. . The posture score that the patient will receive is one of 25 different scores ranging from 13 to 65, and a higher score indicates better posture. Standard evaluation criteria developed for this test were determined as "very good" if the total score is ≥45, "good" if 40-44, "moderate" if 30-39, "poor" if 20-29, and "poor" if ≤19.
Measured: 5 mins
Pain Level assessed by McGill Pain Scale
The McGill Pain Scale Short Form, which is a valid and reliable method used to evaluate pain, consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.
Measured: 5 mins
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Sleep quality of patients will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a valid and reliable assessment tool. The PSQI consists of 7 components that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and loss of daytime functionality. Some of the components consist of a single item, while others consist of groupings of several items. Each item is evaluated between 0 and 3 points. It is accepted that a total scale score of 5 and above indicates poor sleep quality. The sum of these 7 component scores gives the overall index score. The total score is between 0-21. A high total score indicates poor sleep quality.
Measured: 5 mins
Quality of Life assessed by Short Form-12
The Health Scale Short Form-12 (SF-12), which is a valid and reliable tool, will be used to assess patients' quality of life. The SF-12 scale evaluates 8 sub-dimensions as physical function, physical role difficulty, social function, pain, mental health, emotional role difficulty, vitality, general perception of health, and 2 areas, mental health and physical health, which is a combination of these dimensions. Considering the last month, the patient scores some of the items between 1 and 3, some of them between 1 and 5, and the sum of the scores for 8 sub-dimensions and 2 domains separately is expressed as %. A higher percentage indicates a better quality of life.
Measured: 5 mins
Beck Depression Inventory Score
Beck Depression Inventory (BDI) will be used to evaluate the depression status of the patients. BDI is a valid and reliable scale with 21 items, each of which can be scored between 0 (minimal) and 3 (severe hopelessness). The patient answers this scale himself, thinking about the last week. The sum of the scores of the items represents the scale score, and this score ranges from 0 to 63. 0-9 points are interpreted as minimal depression, 10-16 points as mild depression, 17-29 points as moderate depression and 30-63 points as severe depression.
Measured: 5 mins
The Body Awareness Scale Score
Body Awareness Questionnaire is a valid and reliable scale that measures body awareness of individuals for different situations (illness, cold, change in energy level, etc.). It consists of a total of 18 items, each of which can be scored between 1 (completely true for me) and 7 (not true for me at all).
Measured: 5 mins
The Awareness: Body Chart Score
The Awareness: Body Chart (ABC) is a newly developed, valid and reliable scale used to evaluate individuals' body awareness. ABC divides the human body into 51 separate regions and grades each of them separately. It does this by painting with colors, not by grading with numbers. In this coloring, orange is interpreted as "I can perceive in great detail", yellow as "I can perceive clearly", green as "I can perceive", blue as "I can perceive vaguely" and black as "I cannot perceive". The evaluator then converts these colors to numerical values from 5 to 1, respectively (for example, orange = 5). If the patient feels pain using a red felt-tip pen, he marks the area and rates the pain intensity between 0 and 100. A high ABC score of the patient means good awareness, while a high pain score means severe pain.
Measured: 5 mins
Body Image Questionnaire Score
Body Image Questionnaire (BIQ) is a scale that determines satisfaction with one's body parts or functions. Hovardaoğlu et al. found that the scale was valid and reliable. demonstrated in the study by The scale consists of a total of 40 different items, and each item is scored between 1 (I quite like it) and 5 (I don't like it at all). A low score means that the person is satisfied with their body and functions.
Measured: 5 mins
Fremantle Back Awareness Questionnaire Score
The Fremantle Back Awareness Questionnaire (FBAQ) is the only known valid and reliable awareness scale specific to the waist area. This scale consists of 9 items assessing denial-like symptoms, decreased proprioception, perceived body shape and size, and each item is scored between 0 (never) and 4 (always). High scores indicate decreased awareness.
Measured: 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Dec 2020
- Primary completion21 Oct 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- A total of 28 individual diagnosed with chronic low back pain will be included in this study. The patients who meet the inclusion criteria will be divided into 2 groups randomly as study (n=14) and control (n=14). Patients in control group will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation. Patients in study group will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and cognitive exercises
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaniye Üneş, Hacettepe University
- Investigators
- Kaniye Unes, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080101
- Sponsor's protocol ID
- 2020/14-11 (KA-20021)
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Sof Basic Body Awareness Therapy on Posture, Pain, Disability, Quality of Life, Sleep Quality and Body Awareness in Individual With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05080101
- Acronym / sponsor ID
- 2020/14-11 (KA-20021)
- Conditions
- Chronic Low-back Pain
- Keywords
- Pain, Quality of Life, Disability, Sleep, Body Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 15 Oct 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.
Chronic low back pain is a common problem worldwide. In treatment, conservative methods usually are used. Basic Body Awareness Therapy is related to mindfulness-based therapies and meditation techniques. It is a method that has been used and found effective in some diseases affecting the musculoskeletal system. Therefore, in this study, body awareness was applied in addition to conventional treatment in patients with chronic low back pain.
Detailed description
Throughout a lifetime, chronic low back pain is a common problem that affects approximately 80% of people. Among musculoskeletal system problems, it is one of the most commonly observed issues. There are various treatment methods available. The absence of evidence-based treatment guidelines negatively affects the choice of treatment to be applied. There are medical and conservative treatment options. These methods include acupuncture, transcutaneous electrical nerve stimulation, injection therapy, non-steroidal anti-inflammatory drugs, and lumbar supports. Basic Body Awareness Therapy is a physiotherapy treatment method that has been developed in the Scandinavian countries over the course of the last two decades. This innovative approach focuses on enhancing body awareness and has gained recognition as an effective therapeutic technique in the field of physiotherapy. Basic Body Awareness Therapy has been applied as a secondary treatment method in various conditions such as fibromyalgia, neck pain, and ankylosing spondylitis, and has been found to be effective. It has yielded positive results when used in addition to conventional treatments for musculoskeletal problems, as demonstrated in the literature. This study aims to apply Basic Body Awareness Therapy to individuals with chronic low back pain, based on its effectiveness in musculoskeletal issues, and create a new treatment combination. Twenty-eight patients were included in the study, and in addition to the standard treatment protocol, Basic Body Awareness Therapy exercises were administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 28 individual diagnosed with chronic low back pain will be included in this study. The patients who meet the inclusion criteria will be divided into 2 groups randomly as study (n=14) and control (n=14). Patients in control group will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation. Patients in study group will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and cognitive exercises
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | Other: Conventional Therapy ProgramPatients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head. |
| Basic Body Awareness Therapy Group | Experimental | Other: Basic Body Awareness Therapy Group ProgramPatients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having low back pain for 3 months or more
- Being between the ages of 18-65
- Not having received any back-related treatment before
- Volunteer to participate in the study
Key exclusion criteria (9 listed)
- Pregnancy
- History of tumor / metastatic disease
- History of spinal trauma, spinal cord injury
- History of infection
- Presence of congenital deformity in the spine
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 Therapy ProgramPatients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head. | Other | Conventional Physiotherapy Group |
| Basic Body Awareness Therapy Group ProgramPatients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance. | Other | Basic Body Awareness Therapy Group |
Primary outcome
Oswestry Disability Index Score
Time frame: 5 mins
The Oswestry Disability Index (ODI) is the gold standard, valid and reliable outcome measurement tool for assessing functionality in patients with low back pain. For 10 different functional activities, there are 6 different answers for which the patient does not know the score equivalent. Each activity is scored between 0 (functional level adequate) and 5 (severe limitation). The measurement result is expressed over the total score and the ratio of the score to the total maximum score is determined as a percentage. 0-20% minimal disability, 21-40% moderate disability, 41-60% severe disability, 61-80% bedridden, 81-100% completely bedridden or interpreted as exaggerating their situation. The minimal clinical significance level is accepted as 10%, changes occurring less than this rate are considered as measurement error.
Functional Rating Index Score
Time frame: 5 mins
The Functional Rating Index (FRI) is a valid and reliable method that evaluates the functionality and the decrease in functions caused by low back pain. FRI evaluates the functional level in 10 different domain (sleep, personal care, travel, work, etc.) that may be affected due to low back pain. FRI is a scale in which each item is scored between 0 (no pain, no restriction while doing the activity) and 4 (totally dependent, need someone else's help). Maximum score of FRI is 40 which indicates that the patient can easily perform functional activities.
New York Posture Analysis Score
Time frame: 5 mins
The New York Posture Analysis (NYPA) will be used to assess patients' posture. NYPA consists of 13 items that evaluate the static posture of the body from the lateral and posterior aspects, and each item is given a score of five (5) if the person has a correct posture, three (3) if the posture is moderately impaired, and one (1) point if there is a severe deterioration. . The posture score that the patient will receive is one of 25 different scores ranging from 13 to 65, and a higher score indicates better posture. Standard evaluation criteria developed for this test were determined as "very good" if the total score is ≥45, "good" if 40-44, "moderate" if 30-39, "poor" if 20-29, and "poor" if ≤19.
Pain Level assessed by McGill Pain Scale
Time frame: 5 mins
The McGill Pain Scale Short Form, which is a valid and reliable method used to evaluate pain, consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time frame: 5 mins
Sleep quality of patients will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a valid and reliable assessment tool. The PSQI consists of 7 components that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and loss of daytime functionality. Some of the components consist of a single item, while others consist of groupings of several items. Each item is evaluated between 0 and 3 points. It is accepted that a total scale score of 5 and above indicates poor sleep quality. The sum of these 7 component scores gives the overall index score. The total score is between 0-21. A high total score indicates poor sleep quality.
Quality of Life assessed by Short Form-12
Time frame: 5 mins
The Health Scale Short Form-12 (SF-12), which is a valid and reliable tool, will be used to assess patients' quality of life. The SF-12 scale evaluates 8 sub-dimensions as physical function, physical role difficulty, social function, pain, mental health, emotional role difficulty, vitality, general perception of health, and 2 areas, mental health and physical health, which is a combination of these dimensions. Considering the last month, the patient scores some of the items between 1 and 3, some of them between 1 and 5, and the sum of the scores for 8 sub-dimensions and 2 domains separately is expressed as %. A higher percentage indicates a better quality of life.
Beck Depression Inventory Score
Time frame: 5 mins
Beck Depression Inventory (BDI) will be used to evaluate the depression status of the patients. BDI is a valid and reliable scale with 21 items, each of which can be scored between 0 (minimal) and 3 (severe hopelessness). The patient answers this scale himself, thinking about the last week. The sum of the scores of the items represents the scale score, and this score ranges from 0 to 63. 0-9 points are interpreted as minimal depression, 10-16 points as mild depression, 17-29 points as moderate depression and 30-63 points as severe depression.
The Body Awareness Scale Score
Time frame: 5 mins
Body Awareness Questionnaire is a valid and reliable scale that measures body awareness of individuals for different situations (illness, cold, change in energy level, etc.). It consists of a total of 18 items, each of which can be scored between 1 (completely true for me) and 7 (not true for me at all).
The Awareness: Body Chart Score
Time frame: 5 mins
The Awareness: Body Chart (ABC) is a newly developed, valid and reliable scale used to evaluate individuals' body awareness. ABC divides the human body into 51 separate regions and grades each of them separately. It does this by painting with colors, not by grading with numbers. In this coloring, orange is interpreted as "I can perceive in great detail", yellow as "I can perceive clearly", green as "I can perceive", blue as "I can perceive vaguely" and black as "I cannot perceive". The evaluator then converts these colors to numerical values from 5 to 1, respectively (for example, orange = 5). If the patient feels pain using a red felt-tip pen, he marks the area and rates the pain intensity between 0 and 100. A high ABC score of the patient means good awareness, while a high pain score means severe pain.
Body Image Questionnaire Score
Time frame: 5 mins
Body Image Questionnaire (BIQ) is a scale that determines satisfaction with one's body parts or functions. Hovardaoğlu et al. found that the scale was valid and reliable. demonstrated in the study by The scale consists of a total of 40 different items, and each item is scored between 1 (I quite like it) and 5 (I don't like it at all). A low score means that the person is satisfied with their body and functions.
Fremantle Back Awareness Questionnaire Score
Time frame: 5 mins
The Fremantle Back Awareness Questionnaire (FBAQ) is the only known valid and reliable awareness scale specific to the waist area. This scale consists of 9 items assessing denial-like symptoms, decreased proprioception, perceived body shape and size, and each item is scored between 0 (never) and 4 (always). High scores indicate decreased awareness.
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 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Kaniye Unes, PT principal investigator
Hacettepe 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 Conventional Therapy Program and Basic Body Awareness Therapy Group Program in people with Chronic Low-back Pain, run by Hacettepe 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 9 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 25 Oct 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 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?
Oswestry Disability Index Score (time frame: 5 mins). The study lists 11 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 25 Oct 2023.