Chronic Low Back PainPhase 2/3NCT00594243
Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
A Phase 2/3 study testing Mindfulness based stress reduction program in people with Chronic Low Back Pain, run by University of Pittsburgh.
Trial summary
This pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Mindfulness based stress reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jun 2005
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All participants will be included if they are:
- 65 years of age or older,
- have intact cognition (Mini-Mental Status Exam (MMSE) >23),
- CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months, and
- speak English.
Who cannot join
- They will be excluded if they:
- do not meet the above inclusion criteria,
- have previously participated in a mindfulness meditation program, and
- have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
About this study
This pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone (see appendix for checklist). Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized in blocks of six using a simple randomization process with no stratification using a table of random numbers. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37 participants have been recruited into the study to do the intervention, the intervention will be done on a rolling basis. This means there will be a minimum of 6 participants per intervention group, with the possibility of three separate intervention groups. If recruitment goes better than expected, then we will offer the intervention to all 18 participants at one time. Controls will not receive any intervention during this time. Immediately post-intervention the measures will be administered again to participants and wait-list controls. Once the intervention is complete and participants and wait-list controls have completed post-intervention measures the mindfulness meditation program will be offered to the wait-list controls. We will try to combine the wait-list controls into one eight-week program. 3 months after the intervention is completed, participants will be asked to complete the measures a third time and any mindfulness meditation they continue to do at home will be quantified.
The primary hypotheses are:
- We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period.
- We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions.
- We expect mindfulness meditation will result in a moderate effect size difference (0.5) between the intervention participants and wait-list control participants on outcome measures of pain, mood, physical function, attention, and QOL.
- Conditions
- Chronic Low Back Pain
- Being tested
- Mindfulness based stress reduction program, Wait-list control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reduction programBehavioural
8-week mindfulness based stress reduction program
Wait-list controlOther
No treatment given.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 8-week mindfulness based stress reduction program Receives: Behavioral: Mindfulness based stress reduction program |
| Wait-list control | Active comparator | Wait-list received no intervention during the time the treatment group received the 8-week program Receives: Other: Wait-list control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2005
- Study completionJun 2005
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 University of PittsburghThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Natalia E Morone, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594243
- Sponsor's protocol ID
- 0404190
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00594243
- Acronym / sponsor ID
- 0404190
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 15 Jan 2008 (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 pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone (see appendix for checklist). Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized in blocks of six using a simple randomization process with no stratification using a table of random numbers. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37 participants have been recruited into the study to do the intervention, the intervention will be done on a rolling basis. This means there will be a minimum of 6 participants per intervention group, with the possibility of three separate intervention groups. If recruitment goes better than expected, then we will offer the intervention to all 18 participants at one time. Controls will not receive any intervention during this time. Immediately post-intervention the measures will be administered again to participants and wait-list controls. Once the intervention is complete and participants and wait-list controls have completed post-intervention measures the mindfulness meditation program will be offered to the wait-list controls. We will try to combine the wait-list controls into one eight-week program. 3 months after the intervention is completed, participants will be asked to complete the measures a third time and any mindfulness meditation they continue to do at home will be quantified.
The primary hypotheses are:
- We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period.
- We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions.
- We expect mindfulness meditation will result in a moderate effect size difference (0.5) between the intervention participants and wait-list control participants on outcome measures of pain, mood, physical function, attention, and QOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness based stress reduction program8-week mindfulness based stress reduction program |
| Wait-list control | Active comparator | Other: Wait-list controlWait-list received no intervention during the time the treatment group received the 8-week program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years of age or older,
- have intact cognition (Mini-Mental Status Exam (MMSE) >23),
- CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months, and
- speak English.
Key exclusion criteria (4 listed)
- do not meet the above inclusion criteria,
- have previously participated in a mindfulness meditation program, and
- have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
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 |
|---|---|---|
| Mindfulness based stress reduction program8-week mindfulness based stress reduction program | Behavioural | Intervention |
| Wait-list controlNo treatment given. | Other | Wait-list control |
Primary outcome
Not reported in the source record.
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 15 Jan 2008.
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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.
Natalia E Morone, MD, MSc principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mindfulness based stress reduction program in people with Chronic Low Back Pain, run by University of Pittsburgh.
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 5 inclusion and 4 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 15 Jan 2008.