PainNCT02752854
Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study
An observational study of Pain, run by Taif University.
Trial summary
one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale. Read more about this study
- Who is it for?
- Ages 18 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- pain threshold measurement
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2016
- 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 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteer adults
Who may be able to join
- age 18-52 years old.
- healthy volunteers
Who cannot join
- no musculoskeletal problems including muscle spasm
- no recent injuries or operations.
- not suffering from any painful condition.
- not on pain medications or antidepressant
About this study
one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale.
Read the detailed description
the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults.
Assessment performed using:
- pressure algometer.
- situational pain scale
- Conditions
- Pain
- Being tested
- pain threshold measurement
- Keywords
- pain scores, pressure algometer, healthy volunteer adults
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain threshold measurementOther
pressure algometer
| Study group | Role | What they receive |
|---|---|---|
| Group A | Pain threshold measurement in high altitude Receives: Other: pain threshold measurement | |
| Group B | Pain threshold measurement in low altitude Receives: Other: pain threshold measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold assessed with a pressure algometer
pain threshold measurement
Measured: 1 year
Secondary outcomes (1)
situational pain scale
measures pain perception in different painful situations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
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
- Cross-sectional
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nashwa Sayed Hamed, Taif University
- Investigators
- Amro A Almaz, PhD, Study chair, Head of scientific research board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752854
- Sponsor's protocol ID
- TU217
- Other IDs
- U1111-1181-8637
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study
- ClinicalTrials.gov ID
- NCT02752854
- Acronym / sponsor ID
- TU217
- Conditions
- Pain
- Keywords
- pain scores, pressure algometer, healthy volunteer adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 27 Apr 2016 (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.
one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale.
Detailed description
the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults.
Assessment performed using:
- pressure algometer.
- situational pain scale
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: pain threshold measurementPain threshold measurement in high altitude |
| Group B | – | Other: pain threshold measurementPain threshold measurement in low altitude |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteer adults
Key inclusion criteria (2 listed)
- age 18-52 years old.
- healthy volunteers
Key exclusion criteria (4 listed)
- no musculoskeletal problems including muscle spasm
- no recent injuries or operations.
- not suffering from any painful condition.
- not on pain medications or antidepressant
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 |
|---|---|---|
| pain threshold measurementpressure algometer | Other | Group A, Group B |
Primary outcome
Pain threshold assessed with a pressure algometer
Time frame: 1 year
pain threshold measurement
1 secondary outcome
situational pain scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- 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.
Amro A Almaz, PhD study chair
Head of scientific research board
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Taif University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. 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?
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?
Pain threshold assessed with a pressure algometer (time frame: 1 year). 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 27 Apr 2016.