NCT02882971

Brief Summary

Currently, there is no observational pain scale for use in the outpatient setting for adult patients. An observational pain scale can allow for objective measurement of pain in patients over time and after treatment without the bias associated with self-report. Currently chronic pain patients are asked to rate their pain many times throughout their care, often over years. This introduces a bias in reporting as a pain a person is currently experiencing will seem more severe then a remembered pain event. A behavioral pain scale would allow for an objective measurement of pain that is reliable across multiple raters and comparable over time, which can help in judging the success of pain treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

March 22, 2016

Last Update Submit

February 6, 2019

Conditions

Chronic Pain

Keywords

chronic painrating scale

Outcome Measures

Primary Outcomes (2)

  • Patient's pre-procedure pain score using the Chronic Pain Behavioral Scale for Adults.

    2 observers will use the new Chronic Pain Behavioral Scale for Adults to measure the patient's pain before a procedure to alleviate pain.

    Within 30 minutes prior to intervention designed to alleviate pain

  • Patient's pre-procedure pain score using the standard 11-point numerical rating scale.

    The patient will be asked to rate their pain, using the standard 11-point numerical rating scale, before a procedure to alleviate pain.

    Within 30 minutes prior to an intervention designed to alleviate pain

Secondary Outcomes (2)

  • Patient's post-procedure pain score using the Chronic Pain Behavioral Scale for Adults.

    Within 3 h after an intervention designed to alleviate pain

  • Patient's post-procedure pain score using the standard 11-point numerical rating scale.

    Within 3 h after an intervention designed to alleviate pain

Interventions

Pain AssessmentBEHAVIORAL

To create an objective observational pain scoring system and validate.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults between the ages of 18-75 that are able to self-report their pain level using a validated pain scale.

You may qualify if:

  • Adults age 18-75
  • Patients able to self-report their pain using a validated pain scale
  • Patients of the chronic pain clinic who will be receiving a pain treatment procedure
  • English speaking
  • Received and signed a consent to participate in the study

You may not qualify if:

  • Pregnant and lactating women
  • Patient with chronic malignant pain
  • Patients less than 18
  • Patient older than 75
  • Patients with dementia
  • Non-English speaking patients
  • Patients unable to do a self-report pain scale
  • Uncontrolled psychiatric conditions
  • Uncontrolled substance abuse issues
  • Patient's lost to follow-up
  • Patients who don't wish to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • Jensen MP, Turner LR, Turner JA, Romano JM. The use of multiple-item scales for pain intensity measurement in chronic pain patients. Pain. 1996 Sep;67(1):35-40. doi: 10.1016/0304-3959(96)03078-3.

    PMID: 8895229BACKGROUND

  • Pace AK, Bruceta M, Donovan J, Vaida SJ, Eckert JM. An Objective Pain Score for Chronic Pain Clinic Patients. Pain Res Manag. 2021 Feb 8;2021:6695741. doi: 10.1155/2021/6695741. eCollection 2021.

    PMID: 33628355DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jill Eckert, DO

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

March 22, 2016

First Posted

August 30, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)