Chronic Low Back PainNCT03432169
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
A study testing Yoga (stretching plus mindfulness) and Stretching in people with Chronic Low Back Pain, run by Canandaigua VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class) Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Yoga (stretching plus mindfulness) and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2018
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Veterans between the ages of 18-89
- Lower back pain > 12 weeks
- Have the ability to exercise independently.
Who cannot join
- Subjects will be excluded if
- They are currently enrolled in or maintain a home meditation practice
- If they are currently involved in a mindfulness or cognitive behavioral therapy group.
- If they have participated in a structured group yoga class in the last three months.
- If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Rochester, New York, 14620
About this study
The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)
Read the detailed description
The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.
- Conditions
- Chronic Low Back Pain
- Being tested
- Yoga (stretching plus mindfulness), Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga (stretching plus mindfulness)Other
Stretching plus mindfulness
StretchingOther
Stretching alone
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Active comparator | Stretching with mindfulness Receives: Other: Yoga (stretching plus mindfulness) |
| Stretching | Active comparator | Stretching exercises without mindfulness Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.
Measured: 6 months
Secondary outcomes (2)
PROMIS Global Health Scale (GHS):
Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. This form has recently been validated in comparison to the EuroQual. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured.
Measured: baseline, immediately post intervention
Pain, Engagement and General activity (PEG)
An ultra-brief three-item scale derived from the Brief Pain Inventory (BPI), was a reliable and valid measure of pain among primary care patients with chronic musculoskeletal pain and diverse VA ambulatory patients.
Measured: baseline, immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Dougherty, DC, Canandaigua VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432169
- Sponsor's protocol ID
- IRBnet 1135250
- Status last verified
- Oct 2019
- First submitted
- 1 Feb 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
- ClinicalTrials.gov ID
- NCT03432169
- Acronym / sponsor ID
- IRBnet 1135250
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Feb 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.
The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)
Detailed description
The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
| Arm | Type | Receives |
|---|---|---|
| Yoga | Active comparator | Other: Yoga (stretching plus mindfulness)Stretching with mindfulness |
| Stretching | Active comparator | Other: StretchingStretching exercises without mindfulness |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Veterans between the ages of 18-89
- Lower back pain > 12 weeks
- Have the ability to exercise independently.
Key exclusion criteria (5 listed)
- Subjects will be excluded if
- They are currently enrolled in or maintain a home meditation practice
- If they are currently involved in a mindfulness or cognitive behavioral therapy group.
- If they have participated in a structured group yoga class in the last three months.
- If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.
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 |
|---|---|---|
| Yoga (stretching plus mindfulness)Stretching plus mindfulness | Other | Yoga |
| StretchingStretching alone | Other | Stretching |
Primary outcome
Feasibility
Time frame: 6 months
The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.
2 secondary outcomes
PROMIS Global Health Scale (GHS):
Time frame: baseline, immediately post intervention
Pain, Engagement and General activity (PEG)
Time frame: baseline, immediately post intervention
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 10 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (stretching plus mindfulness) and Stretching in people with Chronic Low Back Pain, run by Canandaigua VA Medical Center at 1 site in United States.
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 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: finished, as of the sponsor's last update on 10 Oct 2019. 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 United States. 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?
Feasibility (time frame: 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 10 Oct 2019.