PainNCT02260999
Experimental Study of Detection an Intentional Performance Degradation in Grip Strength
An observational study of Pain, run by Christoph Maier, Prof. Dr..
Trial summary
In this study, the detection of the feigning weakness in grip strength is measured using different grip strength testing instruments. Patients with injury of the upper limb are compared to patients with injury of the lower limb as well as healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Mar 2014
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: chronic pain patients patients with injury at the upper extremity healthy subjects
Who may be able to join
- >18 years, signed consent form, stable pain mediaction for 48 hours
Who cannot join
- <18, unsigned consent form, dose change of the pain medication during the last 48 hours...
About this study
In this study, the detection of the feigning weakness in grip strength is measured using different grip strength testing instruments. Patients with injury of the upper limb are compared to patients with injury of the lower limb as well as healthy controls.
- Conditions
- Pain
- Medical subject headings
- 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 |
|---|---|---|
| healthy | > 18 years old sufficient language knowledge | |
| chronic pain patients | Not described | |
| patients with injury at the upper etxremity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
grip strength
mean and maximum grip strength measured by rapid exchange grip and isometric grip strength testing
Measured: 1 hour
range of motion
measured by the handtutor
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Maier, Prof. Dr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260999
- Sponsor's protocol ID
- BHL-2113
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study of Detection an Intentional Performance Degradation in Grip Strength
- ClinicalTrials.gov ID
- NCT02260999
- Acronym / sponsor ID
- BHL-2113
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Christoph Maier, Prof. Dr.University, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Oct 2014 (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.
In this study, the detection of the feigning weakness in grip strength is measured using different grip strength testing instruments. Patients with injury of the upper limb are compared to patients with injury of the lower limb as well as healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | –> 18 years old sufficient language knowledge |
| chronic pain patients | – | – |
| patients with injury at the upper etxremity | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- chronic pain patients patients with injury at the upper extremity healthy subjects
Key inclusion criteria (1 listed)
- >18 years, signed consent form, stable pain mediaction for 48 hours
Key exclusion criteria (1 listed)
- <18, unsigned consent form, dose change of the pain medication during the last 48 hours...
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
grip strength
Time frame: 1 hour
mean and maximum grip strength measured by rapid exchange grip and isometric grip strength testing
range of motion
Time frame: 1 hour
measured by the handtutor
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 9 Oct 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Christoph Maier, Prof. Dr..
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 1 inclusion and 1 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 9 Oct 2014. 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.
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?
grip strength (time frame: 1 hour). 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 9 Oct 2014.