Pain Threshold Measurements in High and Low Altitude Amon... | NCT02752854

Studies
Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study

NCT02752854

Sponsor

Taif University

Status

Unknown status

Last Update Posted

Apr 27, 2016Estimated

Enrollment

484Estimated

Phase

Not provided

Conditions

Pain

Interventions

pain threshold measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1181-8637	Other Identifier	Universal Trial Number

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

May 2016Estimated

Completion Date

May 2016Estimated

First Submitted Date

Apr 13, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Nashwa Sayed Hamed, Associate professor of physical therapy, Taif UniversityPrincipal Investigator

Lead Sponsor

Taif UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

484Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Pain threshold measurement in high altitude	Other: pain threshold measurement
Group B		Pain threshold measurement in low altitude	Other: pain threshold measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pain threshold measurement	Other	pressure algometer	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain threshold assessed with a pressure algometer	pain threshold measurement	1 year

Secondary Outcomes

Measure	Description	Time Frame
situational pain scale	measures pain perception in different painful situations	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-52 years old.
healthy volunteers

Exclusion Criteria:

no musculoskeletal problems including muscle spasm
no recent injuries or operations.
not suffering from any painful condition.
not on pain medications or antidepressant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

52 Years

Standard Ages

Adult

Study Population

healthy volunteer adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amro A Almaz, PhD	Head of scientific research board	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided