Low Back PainNCT04787094
The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain
A study testing Yoga and Spinal Stabilization Exercise in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Yoga and Spinal Stabilization Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 15 Aug 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic non-specific low back pain diagnosis
- Having pain that persists for at least 12 weeks
- 25-65 age range
Who cannot join
- Scoliosis with a cobb angle of more than 20º
- History of previous surgery for the lumbal region
- Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis
- Presence of neurological deficits
- Metastatic state presence
- Presence of neurological deficits due to diabetes
- Presence of metabolic problems such as thyroid, hypertension, coronary artery disease
- The presence of inflammatory problems involving the spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Yoga and Stabilization Exercises on Pain, Functional Status, Metabolic Capacity and Sleep Quality in Individuals With Chronic Low Back Pain: A Randomized, Crossover Study.
Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. Therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Yoga, Spinal Stabilization Exercise
- Keywords
- spinal stabilization exercise, yoga, low back pain
- 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.
YogaOther
Yoga
Spinal Stabilization ExerciseOther
Spinal Stabilization Exercise
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | The sessions will begin with breathing exercises in standing, sitting, supine and prone positions, and these exercises will be applied for about 10 minutes. After the breathing exercises, the sudden relaxation technique, which will take 2-3 minutes, firstly contracting the whole body from the feet to the head and then completely relaxing it. Receives: Other: Yoga |
| Spinal Stabilization Exercise Group | Experimental | Spinal stabilization exercises will be applied to the individuals in this group for 8 weeks / 2 days a week, approximately 50-60 minutes a day under the supervision of a physiotherapist.
Spinal stabilization exercises will be progressed in 3 phases by gradually increasing the difficulty. Receives: Other: Spinal Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity of participants will be evaluated with visual analog scale (VAS). Paricipants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right. VAS scored between 0-10 cm.
Measured: 15 minutes, through study completion, an average of 8 weeks, Change from pain intensity
Disability Severity
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. The Oswestry Disability Index is scored between 0-50 points. An increase in score indicates a poor result.
Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from disability
Funcitonal Performance
Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Measured: 10 minutes, through study completion, an average of 8 weeks, Change from Functional status and performance
Secondary outcomes (4)
Deep muscle activation
To evaluate the transversus abdominis muscle activation, the stabilizer biofeedback device is placed under the abdomen, just below the spina iliaca anterior superior, while the patient is in the prone position. The cuff of the device is inflated to 70 mmHg, the patient is asked to breathe and pull the abdomen up and in while exhaling, but the patient is warned not to make pelvis and spine movement. In the meantime, how much the pressure has changed is observed from the stabilizer device. In the test, the average of 3 repetitions will be recorded. With successful measurement, the pressure is expected to drop between 6 and 10 mm-Hg.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation
Kinesiophobia
Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain. This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. Physical Activity sub-section scored between 0-24 points. Work sub-sections scored between 0-42 points. The higher the score, the higher the kinesiophobia.
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia
Sleep quality
The Pittsburg Sleep Quality Index will be used to evaluate sleep quality. This questionnaire evaluates sleep quality and disturbance over the past month. The scale consists of 7 subcomponents: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. Each component is scored between 0-3 points. The total score of the 7 components gives the total score of the scale. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality".
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality
Metabolic Capacity
Metabolic capacity evaluation will be performed according to 6 Minute Walk Test. Individuals are asked to walk as fast as possible for 6 minutes without running on the 30 m long corridor. The test is started, the number of rounds is recorded while the patient is walking. Heart rate, blood pressure, oxygen saturation and respiratory frequency will be evaluated and recorded at first, at the end of the test and one minute after. Walking distance is recorded in meters.
Measured: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start15 Feb 2021
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- 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, Ozlem Ulger, Hacettepe University
- Investigators
- Özlem Ülger, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787094
- Sponsor's protocol ID
- KA-20031
- Status last verified
- Oct 2021
- First submitted
- 8 Feb 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga and Stabilization Exercises on Pain, Functional Status, Metabolic Capacity and Sleep Quality in Individuals With Chronic Low Back Pain: A Randomized, Crossover Study.
- ClinicalTrials.gov ID
- NCT04787094
- Acronym / sponsor ID
- KA-20031
- Conditions
- Low Back Pain
- Keywords
- spinal stabilization exercise, yoga, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 8 Mar 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.
Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. Therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: YogaThe sessions will begin with breathing exercises in standing, sitting, supine and prone positions, and these exercises will be applied for about 10 minutes. After the breathing exercises, the sudden relaxation technique, which will take 2-3 minutes, firstly contracting the whole body from the feet to the head and then completely relaxing it. |
| Spinal Stabilization Exercise Group | Experimental | Other: Spinal Stabilization ExerciseSpinal stabilization exercises will be applied to the individuals in this group for 8 weeks / 2 days a week, approximately 50-60 minutes a day under the supervision of a physiotherapist. Spinal stabilization exercises will be progressed in 3 phases by gradually increasing the difficulty. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic non-specific low back pain diagnosis
- Having pain that persists for at least 12 weeks
- 25-65 age range
Key exclusion criteria (8 listed)
- Scoliosis with a cobb angle of more than 20º
- History of previous surgery for the lumbal region
- Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis
- Presence of neurological deficits
- Metastatic state presence
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 |
|---|---|---|
| YogaYoga | Other | Yoga Group |
| Spinal Stabilization ExerciseSpinal Stabilization Exercise | Other | Spinal Stabilization Exercise Group |
Primary outcome
Pain Intensity
Time frame: 15 minutes, through study completion, an average of 8 weeks, Change from pain intensity
Pain intensity of participants will be evaluated with visual analog scale (VAS). Paricipants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right. VAS scored between 0-10 cm.
Disability Severity
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from disability
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. The Oswestry Disability Index is scored between 0-50 points. An increase in score indicates a poor result. Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Funcitonal Performance
Time frame: 10 minutes, through study completion, an average of 8 weeks, Change from Functional status and performance
Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
4 secondary outcomes
Deep muscle activation
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation
Kinesiophobia
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia
Sleep quality
Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality
Metabolic Capacity
Time frame: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.
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 20 Oct 2021.
- Individual participant dataSharing planned: No. 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.
Özlem Ülger, Prof 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 Yoga and Spinal Stabilization Exercise in people with 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 3 inclusion and 8 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 20 Oct 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 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?
Pain Intensity (time frame: 15 minutes, through study completion, an average of 8 weeks, Change from pain intensity). 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 Oct 2021.