Chronic Low Back PainMW-LBPNCT01893073
Mindful Walking in Low Back Pain
A study testing Mindful walking program in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Mindful walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Mar 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female, 18-65 years
- chronic low back pain (disease duration > 3 months)
- pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- undersigned informed consent form
Who cannot join
- active walking or jogging in the last 6 weeks (< 60 minutes/week)
- regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (> 30 minutes per week)
- use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
- use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
- participation in another trials within the last 3 months
- pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
Show all 14Show fewer
- risk of falls and inability to walk
- angina pectoris in the last 3 months
- chronic respiratory disease with respiratory insufficiency
- intake of central nervous system-acting analgesics in the last 6 weeks
- Known renal and / or hepatic diseases
- Severe organic, psychological or psychiatric disorders that are not permitting a study participation
- applying for early retirement due to low back pain
- no undersigned informed consent form
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany
Berlin, State of Berlin, 10117
About this study
Official title: Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Mindful walking program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful walking programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindful walking | Active comparator | A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks. Receives: Behavioral: Mindful walking program |
| Waiting group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity on visual analogue scale
Measured: 8 weeks
Secondary outcomes (6)
Back function - FFbH-R-Questionnaire
Measured: 8 weeks, 12 weeks
Pain intensity on visual analogue scale
Measured: 12 weeks
Cohens perceived stress scale
Measured: 8 weeks, 12 weeks
Quality of Life - SF 36
Measured: 8 weeks, 12 weeks
Intake of paracetamol
Measured: 8 weeks
Adverse events
Measured: 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Charite University, Berlin, GermanyThe 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893073
- Sponsor's protocol ID
- MW-LBP
- Acronym
- MW-LBP
- Status last verified
- Mar 2014
- First submitted
- 2 Jul 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
Publications
Rotter G, Ortiz M, Binting S, Tomzik J, Reese F, Roll S, Brinkhaus B, Teut M. Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):474-483. doi: 10.1089/jicm.2021.0361. Epub 2022 Mar 30.
PubMed 35363058
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01893073
- Acronym / sponsor ID
- MW-LBP / MW-LBP
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 8 Jul 2013 (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.
The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful walking | Active comparator | Behavioral: Mindful walking programA weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks. |
| Waiting group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male and female, 18-65 years
- chronic low back pain (disease duration > 3 months)
- pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- undersigned informed consent form
Key exclusion criteria (14 listed)
- active walking or jogging in the last 6 weeks (< 60 minutes/week)
- regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (> 30 minutes per week)
- use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
- use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
- participation in another trials within the last 3 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 |
|---|---|---|
| Mindful walking program | Behavioural | Mindful walking |
Primary outcome
Pain intensity on visual analogue scale
Time frame: 8 weeks
6 secondary outcomes
Back function - FFbH-R-Questionnaire
Time frame: 8 weeks, 12 weeks
Pain intensity on visual analogue scale
Time frame: 12 weeks
Cohens perceived stress scale
Time frame: 8 weeks, 12 weeks
Quality of Life - SF 36
Time frame: 8 weeks, 12 weeks
Intake of paracetamol
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks, 12 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 26 Mar 2014.
- Derived from this study: PubMed 35363058Rotter G, Ortiz M, Binting S, Tomzik J, Reese F, Roll S, Brinkhaus B, Teut M. Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):474-483. doi: 10.1089/jicm.2021.0361. Epub 2022 Mar 30.
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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 Mindful walking program in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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 14 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 26 Mar 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 Germany. 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?
Pain intensity on visual analogue scale (time frame: 8 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 NCT01893073, which also lists 1 linked publication.
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 26 Mar 2014.