Low Back PainNCT02244645
Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial
A study testing passive modality and Yoga treatment in people with Low Back Pain, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial summary
This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- passive modality and Yoga treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Nov 2015
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with idiopathic low back pain of more than 12 weeks.
Who cannot join
- Current pregnancy
- Diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome and other chronic illnesses.
- Inability to participate yoga exercise regularly.
- Accept steroid treatment within 3 months.
- BMI > 30
Trial locations and contacts
1 site in 1 country.
Shu-Hui Yeh, PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County
Kuender D. Yang, PhD, 886-975617006, yangkd.yeh@hotmail.com
About this study
This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain.
Read the detailed description
Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which influence the work and quality of life. Yoga is one of the most popular complementary and alternative medicine for back pain, and this mind-body intervention has increasingly chosen to effectively treat chronic pain.
This is a parallel-arm randomized controlled trial which will compare the outcomes of participants assigned to the experimental treatment group (yoga, with 36 participants) with those assigned to a passive modality control group for 3 months (12 weeks). Each group will receive regular 60-minutes yoga classes or passive modality twice a week. The investigators confer the difference of pain relief and functional life improvement between passive modality and yoga. The latter is expected to have positive effects on Chronic low back pain. The effects and possible mechanisms of action responsible for passive modality and yoga on salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic factor improved, (5) heart rate variability improved, and (6) immune function improved significantly among the participants in the experimental group than the control group.
This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. If the results are positive, clinicians will attain more options for treating patient with chronic low back. Furthermore, the positive results from this study will help focus more future in-depth research on the most promising potential mechanism of action identifies.
- Conditions
- Low Back Pain
- Being tested
- passive modality, Yoga treatment
- Keywords
- Low back pain, physical therapy, yoga.
- 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.
passive modalityBehavioural
Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
Yoga treatmentBehavioural
Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Passive modality control group | Other | Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months. Receives: Behavioral: passive modality |
| Yoga treatment group | Experimental | Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months. Receives: Behavioral: Yoga treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain relief and functional life improved
Back pain relief and functional life improved will assessed by visual analogue scale (VAS) and Roland-Morris disability questionnaire at five different times: (1)baseline data : before intervention, (2)outcome data: 3, 6, 9 and 12 week yoga exercise, right after exercise measure post-test.
Measured: Change from baseline in back pain and life quality at 6 months
Secondary outcomes (4)
Salivary cortisol concentrations decreased
Cortisol concentrations will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Measured: Change from baseline in salivary cortisol at 6 months
Heart rate variability improved
Heart rate variability will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Measured: Change from baseline in heart rate variability at 6 months
Immune function improved
Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10), lipid prolife and C-reactive protein at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Measured: Change from baseline in immune function at 6 months
Brain-derived neurotrophic factor improved
Brain-derived neurotrophic factor will be assessed by blood analysis at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Measured: Change from baseline in brain-derived neurotrophic factor at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Bing Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
- Investigators
- Kuender D. Yang, MD, PhD, Study chair, Chang Bing Show Chwan Memorial HospitalShu-Hui Yeh, PhD., Study director, Chang Bing Show Chwan Memorial HospitalKwan-Yu Chan, MD., Principal investigator, Chang Bing Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244645
- Sponsor's protocol ID
- 1010803
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02244645
- Acronym / sponsor ID
- 1010803
- Conditions
- Low Back Pain
- Keywords
- Low back pain, physical therapy, yoga.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain.
Detailed description
Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which influence the work and quality of life. Yoga is one of the most popular complementary and alternative medicine for back pain, and this mind-body intervention has increasingly chosen to effectively treat chronic pain.
This is a parallel-arm randomized controlled trial which will compare the outcomes of participants assigned to the experimental treatment group (yoga, with 36 participants) with those assigned to a passive modality control group for 3 months (12 weeks). Each group will receive regular 60-minutes yoga classes or passive modality twice a week. The investigators confer the difference of pain relief and functional life improvement between passive modality and yoga. The latter is expected to have positive effects on Chronic low back pain. The effects and possible mechanisms of action responsible for passive modality and yoga on salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic factor improved, (5) heart rate variability improved, and (6) immune function improved significantly among the participants in the experimental group than the control group.
This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. If the results are positive, clinicians will attain more options for treating patient with chronic low back. Furthermore, the positive results from this study will help focus more future in-depth research on the most promising potential mechanism of action identifies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive modality control group | Other | Behavioral: passive modalityPassive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months. |
| Yoga treatment group | Experimental | Behavioral: Yoga treatmentYoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with idiopathic low back pain of more than 12 weeks.
Key exclusion criteria (5 listed)
- Current pregnancy
- Diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome and other chronic illnesses.
- Inability to participate yoga exercise regularly.
- Accept steroid treatment within 3 months.
- BMI > 30
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 |
|---|---|---|
| passive modalityPassive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months. | Behavioural | Passive modality control group |
| Yoga treatmentYoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months. | Behavioural | Yoga treatment group |
Primary outcome
Back pain relief and functional life improved
Time frame: Change from baseline in back pain and life quality at 6 months
Back pain relief and functional life improved will assessed by visual analogue scale (VAS) and Roland-Morris disability questionnaire at five different times: (1)baseline data : before intervention, (2)outcome data: 3, 6, 9 and 12 week yoga exercise, right after exercise measure post-test.
4 secondary outcomes
Salivary cortisol concentrations decreased
Time frame: Change from baseline in salivary cortisol at 6 months
Heart rate variability improved
Time frame: Change from baseline in heart rate variability at 6 months
Immune function improved
Time frame: Change from baseline in immune function at 6 months
Brain-derived neurotrophic factor improved
Time frame: Change from baseline in brain-derived neurotrophic factor at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
Shu-Hui Yeh, PhD contact
Kuender D. Yang, MD, PhD study chair
Chang Bing Show Chwan Memorial Hospital
Shu-Hui Yeh, PhD. study director
Chang Bing Show Chwan Memorial Hospital
Kwan-Yu Chan, MD. principal investigator
Chang Bing Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive modality and Yoga treatment in people with Low Back Pain, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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 19 Sep 2014. 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 Taiwan. 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 Shu-Hui Yeh, PhD (yehshuhui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain relief and functional life improved (time frame: Change from baseline in back pain and life quality at 6 months). 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 19 Sep 2014.