Chronic Low Back PainRelaxbackNCT02019498
Effectiveness of App-based Relaxation for Patients With Chronic Low Back Pain (Relaxback)
A study testing Relaxation exercise and ususal care in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone. 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?
- Relaxation exercise and ususal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jul 2016
- 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
- female or male
- 18-65 years of age
- chronic low back pain for at least 12 weeks
- if additional back pain is reported, low back pain has to be predominant
- intensity of the average low back pain ≥ 4 on the numeric rating scale (NRS) in the last week
- presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
- willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by an App physical and mental ability to participate in the study
- written and oral informed consent
Who cannot join
- low back pain caused by a known malignant disease
- neck pain caused by trauma
- known rheumatic disorder
- history or planned surgery of the spinal column of the low back in the next 6 months
- known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
- regular intake of analgesics (>1x per week) because of additional diseases
Show all 14Show fewer
- intake of centrally acting analgesics
- known severe acute or chronic disorder, that do not allow participation in the therapy
- other known diseases, that do not allow participation in the therapy
- known alcohol or substance abuse
- no sufficient German language skills
- current application for a benefit
- participation in another clinical trial during six months before the study and parallel to the study
- conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Read the detailed description
Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Study design: Open single-centered randomized two-armed pragmatic trial.
Participants: 220 patients aged 18-65 years with chronic (>12 weeks) low back pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)
Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.
Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.
- Conditions
- Chronic Low Back Pain
- Being tested
- Relaxation exercise, ususal care
- Keywords
- low back pain, relaxation
- 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.
Relaxation exerciseBehavioural
Also called meditation
Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply
ususal careOther
Also called waiting list
Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
| Study group | Role | What they receive |
|---|---|---|
| relaxation | Experimental | Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply Receives: Behavioral: Relaxation exercise |
| Usual care waiting list | Active comparator | Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy Receives: Other: ususal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
Measured: 3 months
Secondary outcomes (8)
Mean pain intensity measured by the daily pain intensity on the NRS
Measured: 6 months
Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
Measured: 3 and 6 months
Pain acceptance
German version of Chronic Pain Acceptance Questionnaire
Measured: 3 and 6 months
Stress
NRS
Measured: 3 and 6 months
Suspected adverse reaction
Measured: 3 and 6 months
Number of Serious adverse event
Measured: 3 and 6 months
medication intake
Measured: 3 and 6 months
Number of sick leave days
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionJul 2016
Why it stopped: Recruitment problems
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019498
- Sponsor's protocol ID
- RelaxLWS-13
- Acronym
- Relaxback
- Status last verified
- Feb 2016
- First submitted
- 18 Dec 2013
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blodt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014 Dec 15;15:490. doi: 10.1186/1745-6215-15-490.
PubMed 25511185
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02019498
- Acronym / sponsor ID
- Relaxback / RelaxLWS-13
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, relaxation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Dec 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 aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Detailed description
Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Study design: Open single-centered randomized two-armed pragmatic trial.
Participants: 220 patients aged 18-65 years with chronic (>12 weeks) low back pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)
Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.
Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| relaxation | Experimental | Behavioral: Relaxation exerciseParticipants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply |
| Usual care waiting list | Active comparator | Other: ususal carePatients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female or male
- 18-65 years of age
- chronic low back pain for at least 12 weeks
- if additional back pain is reported, low back pain has to be predominant
- intensity of the average low back pain ≥ 4 on the numeric rating scale (NRS) in the last week
Key exclusion criteria (14 listed)
- low back pain caused by a known malignant disease
- neck pain caused by trauma
- known rheumatic disorder
- history or planned surgery of the spinal column of the low back in the next 6 months
- known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
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 |
|---|---|---|
| Relaxation exerciseAlso: meditationParticipants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply | Behavioural | relaxation |
| ususal careAlso: waiting listParticipants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy | Other | Usual care waiting list |
Primary outcome
Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
Time frame: 3 months
8 secondary outcomes
Mean pain intensity measured by the daily pain intensity on the NRS
Time frame: 6 months
Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS
Time frame: 3 and 6 months
Pain acceptance
Time frame: 3 and 6 months
Stress
Time frame: 3 and 6 months
Suspected adverse reaction
Time frame: 3 and 6 months
Number of Serious adverse event
Time frame: 3 and 6 months
medication intake
Time frame: 3 and 6 months
Number of sick leave days
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 25511185Blodt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014 Dec 15;15:490. doi: 10.1186/1745-6215-15-490.
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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.
Claudia M Witt, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation exercise and ususal care 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 8 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: stopped early, as of the sponsor's last update on 3 Aug 2016. 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 was stopped early (reason given: Recruitment problems). Results are not available in the source record.
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?
Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) (time frame: 3 months). 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 NCT02019498, 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 3 Aug 2016.