Chronic Low Back PainMedExTNCT03324659
Meditation and Exercise to Treat Chronic Back Pain
A study testing Exercise and Meditation in people with Chronic Low Back Pain, run by Duquesne University at 1 site in United States.
Trial summary
This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exercise and Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 30 Jun 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of clinically diagnosed nonspecific low back pain for at least 6 months
- Body mass index within the normal to overweight range (18.5-29.9)
- Resting heart rate 60 to 100 beats per minute
- Resting blood pressure less than or equal to 140/90
- Able to independently ambulate community distances without external support (e.g., walker, cane)
Who cannot join
- Age less than 18 or greater than 60 years
- BMI ≥ 30 or ≤ 18.4
- Cardiovascular or respiratory disease
- Neurological disease, unrelated to low back pain
- Radicular low back pain
- Back pain associated with neuropathy
Show all 16Show fewer
- Diabetes mellitus, Types 1 and 2
- Diagnosed with a chronic pain condition, unrelated to low back pain
- Acute pain
- Regular participation in high intensity athletic/sporting activities
- Sedentary lifestyle
- Currently pregnant
- Current cigarette smoker
- On-going litigation associated with back pain
- Inability to walk independently without external support (e.g. walker).
- Regular participation in meditation techniques or training in Mindfulness-based stress reduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.
Read the detailed description
Exercise and mindfulness based mediation can both produce analgesic effects in patients with chronic pain, but the mechanisms are not clear.
Combining treatments could produce analgesic effects that are additive, synergistic, or counteractive to each other. Here, the investigators examine the effects of a 4-week intervention in patients with chronic low back pain. Patients are assigned to a meditation/exercise group or a control group. The investigators will measure pain and disability using a variety of tools including surveys (disability, anxiety, mindfulness, and pain), pain VAS scales, and quantitative sensory testing.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exercise and Meditation, Control
- Keywords
- Mindfulness, Exercise, Meditation, Back pain
- Medical subject headings
- Motor Activity, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and MeditationBehavioural
The Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks.
ControlBehavioural
The Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Meditation | Experimental | The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks. Receives: Behavioral: Exercise and Meditation |
| Control | Sham comparator | The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Roland Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).
Measured: baseline and 4 weeks
Secondary outcomes (7)
Change in Cutaneous Sensation
Subjects will be examined using cutaneous sensory filaments on the forearm with data recorded in grams.
Measured: baseline and 4 weeks
Fear Avoidance Beliefs Questionnaire
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception, a model created in attempts to explain why some patients with acute painful conditions can recover while other patients develop chronic pain from such conditions. The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. This questionnaire consists of 16 items, with each item scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs
Measured: baseline and 4 weeks
Freiburg Mindfulness Inventory
The FMI is a 14-item questionnaire for measuring mindfulness. It is most suitable in generalized contexts, where knowledge of the Buddhist background of mindfulness cannot be expected. The 14 items cover all aspects of mindfulness. The purpose is to characterize the experience of mindfulness. The subject is asked to answer every statement as honestly and spontaneously as possible. Each statement is scored on a 1 to 4 scale and a composite score is calculated from all statements.
Measured: baseline and 4 weeks
VAS back pain (intensity & unpleasantness)
Participants will be asked to rate their current level of back pain intensity on a Visual Analog Scale (VAS) ranging from 0 to 10
Measured: baseline, daily (pre and post intervention), and 4 weeks
State-Trait Anxiety Inventory (STAI)
The STAI is an introspective psychological inventory consisting of 40 self-report items pertaining to anxiety affect. It distinguishes between a person's state and trait anxiety levels. The A-Trait and A-State scales comprise 20 items each, scored on a 4-point Likert-type response scale. Higher STAI scores suggest higher levels of anxiety.
Measured: baseline and 4 weeks
Change in Pressure Sensation
Subjects will be examined using a pressure algometer to determine a pressure pain threshold, measured in Newtons
Measured: baseline and 4 weeks
Change in Heat unpleasantness
Subjects will be examined using a heat block with a determined temperature threshold. Subjects will report unpleasantness using a VAS scale.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start26 Jan 2018
- Primary completion31 Mar 2019
- Study completion30 Jun 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Matthew Kostek, Duquesne University
- Investigators
- Matthew C. Kostek, PhD, Principal investigator, Duquesne UniversityBenedict J Kolber, PhD, Principal investigator, Duquesne UniversityEric Helm, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324659
- Sponsor's protocol ID
- Protocol50
- Acronym
- MedExT
- Status last verified
- Apr 2021
- First submitted
- 17 Oct 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT03324659
- Acronym / sponsor ID
- MedExT / Protocol50
- Conditions
- Chronic Low Back Pain
- Keywords
- Mindfulness, Exercise, Meditation, Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Oct 2017 (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.
This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.
Detailed description
Exercise and mindfulness based mediation can both produce analgesic effects in patients with chronic pain, but the mechanisms are not clear.
Combining treatments could produce analgesic effects that are additive, synergistic, or counteractive to each other. Here, the investigators examine the effects of a 4-week intervention in patients with chronic low back pain. Patients are assigned to a meditation/exercise group or a control group. The investigators will measure pain and disability using a variety of tools including surveys (disability, anxiety, mindfulness, and pain), pain VAS scales, and quantitative sensory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Meditation | Experimental | Behavioral: Exercise and MeditationThe Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks. |
| Control | Sham comparator | Behavioral: ControlThe Control group will listen to an audio book followed by quiet rest, five days per week for four weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of clinically diagnosed nonspecific low back pain for at least 6 months
- Body mass index within the normal to overweight range (18.5-29.9)
- Resting heart rate 60 to 100 beats per minute
- Resting blood pressure less than or equal to 140/90
- Able to independently ambulate community distances without external support (e.g., walker, cane)
Key exclusion criteria (16 listed)
- Age less than 18 or greater than 60 years
- BMI ≥ 30 or ≤ 18.4
- Cardiovascular or respiratory disease
- Neurological disease, unrelated to low back pain
- Radicular low back 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 |
|---|---|---|
| Exercise and MeditationThe Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks. | Behavioural | Exercise and Meditation |
| ControlThe Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks. | Behavioural | Control |
Primary outcome
Change in Roland Morris Disability Questionnaire
Time frame: baseline and 4 weeks
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).
7 secondary outcomes
Change in Cutaneous Sensation
Time frame: baseline and 4 weeks
Fear Avoidance Beliefs Questionnaire
Time frame: baseline and 4 weeks
Freiburg Mindfulness Inventory
Time frame: baseline and 4 weeks
VAS back pain (intensity & unpleasantness)
Time frame: baseline, daily (pre and post intervention), and 4 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: baseline and 4 weeks
Change in Pressure Sensation
Time frame: baseline and 4 weeks
Change in Heat unpleasantness
Time frame: baseline and 4 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 5 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Matthew C. Kostek, PhD principal investigator
Duquesne University
Benedict J Kolber, PhD principal investigator
Duquesne University
Eric Helm, MD principal investigator
University of Pittsburgh
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 and Meditation in people with Chronic Low Back Pain, run by Duquesne University 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 5 inclusion and 16 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 5 Apr 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 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. Some participants in this study may receive a placebo. 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?
Change in Roland Morris Disability Questionnaire (time frame: baseline and 4 weeks). 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 5 Apr 2021.