Chronic Low Back PainNCT03676062
The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain
A study testing exercise in people with Chronic Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Aug 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be pain at least 3 months
- Must be visual analog scale rating 3 or more
Who cannot join
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
- Diabetes
- Metabolic syndrome
- History of exercise programs or yoga at least 12 weeks before the onset of study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Health Sciences Faculty
Ankara, Altındag, 06100
About this study
Official title: Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması
Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.
Read the detailed description
44 patients participating in the study were divided three groups. The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the home exercise group were instructed to perform stabilization exercise. The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. Assessments were repeated before and after the treatment.
- Conditions
- Chronic Low Back Pain
- Being tested
- exercise
- Keywords
- exercise, pain, yoga
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
All exercises programs applied three sessions per week, totally six week.
| Study group | Role | What they receive |
|---|---|---|
| stabilization exercise group | Active comparator | Spinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist. Receives: Other: exercise |
| yoga group | Active comparator | Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing exercises, warm up, asana and relaxation. Receives: Other: exercise |
| home exercise group | Active comparator | Home exercise were applied all patients in this group supervised, controlled by physiotherapist every week.To make compliance easier for patients; a booklet including suggestions to prevent low back pain and description of exercises, were given. Prescribed exercises were selected in this booklet and checked\&progressed in each control sessions. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain severity
Patients' average resting and activity pain intensities assessed by Visual Analog Scale.
The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.
Measured: change from baseline in pain severity at 6 weeks.
Secondary outcomes (4)
Changes in quality of life
Health-related quality of life assessed by Nottingham Health Profile (NHP). The NSP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. Lower scores denoting a better quality of life.
Measured: Change from baseline in life quality levels at 6 weeks.
Changes of functional status
Patient's permanent functional disability 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.
Measured: change from baseline in functional status at 6 weeks
Changes of stress level
Patients' stress levels were measured with State Trait Anxiety Inventory. State anxiety scale questions how does a person feel in a given moment and situation, mean while trait anxiety scale questions how does a person usually feel without depending on situation and moment. Scale contain 40 questions, minimum and maximum score 20-80, respectively. Scores below 36 accepted as "no-anxiety", between 37-42 accepted as "low-anxiety", 42 and above accepted as "high-anxiety.
Measured: change from baseline in stress level at 6 weeks
Changes of stress related biomarkers
Venous blood samples were taken from antecubital area between 08.30-09.00 am and stress related markers (DHEA(S) and cortisol) were analyzed. All analyses were performed in the same laboratory.
Measured: change from baseline in serum level at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startMar 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzeyyen Oz, Hacettepe University
- Investigators
- Müzeyyen ÖZ, MSc, Principal investigator, Hacettepe UniversityÖzlem ÜLGER, Asc. Proff, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676062
- Sponsor's protocol ID
- GO15/81
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
PubMed 23411647Nambi GS, Inbasekaran D, Khuman R, Devi S, Shanmugananth, Jagannathan K. Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study. Int J Yoga. 2014 Jan;7(1):48-53. doi: 10.4103/0973-6131.123481.
PubMed 25035607Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T; Japan Low back-pain Exercise Therapy Study; Investigators Japanese Orthopaedic Association; Japanese Society for Musculoskeletal Rehabilitation; Japanese Clinical Orthopaedic Association. Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):E811-9. doi: 10.1097/BRS.0b013e3181d7a4d2.
PubMed 20628332Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.
PubMed 26180363
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması
- ClinicalTrials.gov ID
- NCT03676062
- Acronym / sponsor ID
- GO15/81
- Conditions
- Chronic Low Back Pain
- Keywords
- exercise, pain, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Sep 2018 (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.
Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.
Detailed description
44 patients participating in the study were divided three groups. The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the home exercise group were instructed to perform stabilization exercise. The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. Assessments were repeated before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stabilization exercise group | Active comparator | Other: exerciseSpinal stabilization exercise were applied all patients additional with hotpack, TENS application in this group accompanied by physiotherapist. |
| yoga group | Active comparator | Other: exerciseYoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing exercises, warm up, asana and relaxation. |
| home exercise group | Active comparator | Other: exerciseHome exercise were applied all patients in this group supervised, controlled by physiotherapist every week.To make compliance easier for patients; a booklet including suggestions to prevent low back pain and description of exercises, were given. Prescribed exercises were selected in this booklet and checked\&progressed in each control sessions. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be pain at least 3 months
- Must be visual analog scale rating 3 or more
Key exclusion criteria (8 listed)
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
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 |
|---|---|---|
| exerciseAll exercises programs applied three sessions per week, totally six week. | Other | home exercise group, stabilization exercise group, yoga group |
Primary outcome
Changes in pain severity
Time frame: change from baseline in pain severity at 6 weeks.
Patients' average resting and activity pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.
4 secondary outcomes
Changes in quality of life
Time frame: Change from baseline in life quality levels at 6 weeks.
Changes of functional status
Time frame: change from baseline in functional status at 6 weeks
Changes of stress level
Time frame: change from baseline in stress level at 6 weeks
Changes of stress related biomarkers
Time frame: change from baseline in serum level at 6 weeks
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 19 Sep 2018.
- Results publication: PubMed 23411647Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
- Results publication: PubMed 25035607Nambi GS, Inbasekaran D, Khuman R, Devi S, Shanmugananth, Jagannathan K. Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study. Int J Yoga. 2014 Jan;7(1):48-53. doi: 10.4103/0973-6131.123481.
- Results publication: PubMed 20628332Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T; Japan Low back-pain Exercise Therapy Study; Investigators Japanese Orthopaedic Association; Japanese Society for Musculoskeletal Rehabilitation; Japanese Clinical Orthopaedic Association. Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):E811-9. doi: 10.1097/BRS.0b013e3181d7a4d2.
- Results publication: PubMed 26180363Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Müzeyyen ÖZ, MSc principal investigator
Hacettepe University
Özlem ÜLGER, Asc. Proff study director
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 exercise 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 2 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 19 Sep 2018. 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?
Changes in pain severity (time frame: change from baseline in pain severity at 6 weeks.). 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 NCT03676062, which also lists 4 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 19 Sep 2018.