Back Painchron_painNCT02600663
Identification of Patients at Risk of Chronic Back Pain Using Questionnaires
An observational study of Back Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Patients with acute back pain (<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Back Pain
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2016to 14 Oct 2019
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with acute back pain presenting at the general pratcioner
Who may be able to join
- acute (<6 weeks) back pain
- >20 und <60 years of age
- good oral and written knowledge of German language
Who cannot join
- any treatment for back pain within the last 6 months
- Cauda equina
- tumor
- generalized pain
- severe systemic illness
- substance abuse
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Patients with acute back pain (<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.
- Conditions
- Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute back pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of chronic back pain determined by Heidelberger short questionnaire score
Measured: at enrolment
risk of chronic back pain determined by Keele questionnaire
Measured: at enrolment
Secondary outcomes (5)
numeric rating scale average pain intensity
Measured: at enrolment, at 6 months
numeric rating scale minimal pain intensity
Measured: at enrolment, at 6 months
numeric rating scale pain related sleep-loss
Measured: at enrolment, at 6 months
clothepin-algometry (numeric rating scale)
Measured: at enrolment
working days missed
Measured: at enrolment, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start1 Apr 2016
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600663
- Sponsor's protocol ID
- 2015-10
- Acronym
- chron_pain
- Status last verified
- Dec 2019
- First submitted
- 5 Nov 2015
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients at Risk of Chronic Back Pain Using Questionnaires
- ClinicalTrials.gov ID
- NCT02600663
- Acronym / sponsor ID
- chron_pain / 2015-10
- Conditions
- Back Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 9 Nov 2015 (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.
Patients with acute back pain (<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute back pain | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with acute back pain presenting at the general pratcioner
Key inclusion criteria (3 listed)
- acute (<6 weeks) back pain
- >20 und <60 years of age
- good oral and written knowledge of German language
Key exclusion criteria (7 listed)
- any treatment for back pain within the last 6 months
- Cauda equina
- tumor
- generalized pain
- severe systemic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk of chronic back pain determined by Heidelberger short questionnaire score
Time frame: at enrolment
risk of chronic back pain determined by Keele questionnaire
Time frame: at enrolment
5 secondary outcomes
numeric rating scale average pain intensity
Time frame: at enrolment, at 6 months
numeric rating scale minimal pain intensity
Time frame: at enrolment, at 6 months
numeric rating scale pain related sleep-loss
Time frame: at enrolment, at 6 months
clothepin-algometry (numeric rating scale)
Time frame: at enrolment
working days missed
Time frame: at enrolment, at 6 months
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 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?
An observational study of Back Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 7 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 10 Dec 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 Switzerland. 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: insufficient recruitment). 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?
risk of chronic back pain determined by Heidelberger short questionnaire score (time frame: at enrolment). The study lists 2 primary outcomes in all. 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 Dec 2019.