Objective Pain Score for Chronic Pain Clinic Patients

NCT ID: NCT02882971

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective observational study. No changes in therapy will be initiated due to the information gathered by its protocol. All medical decisions will be based on the management of the clinical team. Data will be gathered during the subject's clinical visit, from the subject, and from the nursing staff caring for the subject.

The Chronic Pain Behavioral Pain Scale for Adults was developed by the research team based on behavior pain scales used in other populations and the clinical expertise of Chronic Pain specialists in the Hershey Medical Center Chronic Pain department.

Patients will be scored on the Chronic Pain Behavioral Pain Scale for Adults and the standard 11 point numeric rating scale (Jensen, Turner et al., 1996), on intake. Scoring will be done by the patient's assigned nurse and a member of the research team, at the time when the numeric pain score is typically obtained. The patient will be scored again on both the Chronic Pain Behavioral Pain Scale for Adults and the standard numeric rating pain scale at the conclusion of their procedure, again at the time when the numerical pain score is typically obtained. Scoring will again be done by the patient's assigned nurse and a member of the research team. The Chronic Pain Behavioral Pain Scale for Adults will be tested for inter-rater reliability using the paired scores from the nurse and researcher for each subject. Concurrent Validity will be measured using comparison between the numeric rating scale and the behavioral pain scale on each subject at each time point. Construct validity will be measured by comparing the behavioral pain score before and after the interventional pain treatment.

For training purposes, the assigned nurse and research team member will be provided a copy of the "Chronic Pain Behavioral Pain Scale for Adults" chart to be utilized during their patient encounters. Each team member will be individually instructed in the use of the scale immediately preceding their first use of the scales. This training will include a discussion of the elements, the definition of behaviors, and the use of the scoring system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pain Assessment

To create an objective observational pain scoring system and validate.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant and lactating women
2. Patient with chronic malignant pain
3. Patients less than 18
4. Patient older than 75
5. Patients with dementia
6. Non-English speaking patients
7. Patients unable to do a self-report pain scale
8. Uncontrolled psychiatric conditions
9. Uncontrolled substance abuse issues
10. Patient's lost to follow-up
11. Patients who don't wish to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jill Eckert

Associate Professor of Anesthesiology and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jill Eckert, DO

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8895229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33628355 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00003685

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Pain Predictors in Major Trauma
NCT07237152 NOT_YET_RECRUITING
Alpha as a Predictive Biomarker
NCT02796625 COMPLETED NA