Chronic PainNCT02882971
Objective Pain Score for Chronic Pain Clinic Patients
An observational study of Chronic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults between the ages of 18-75 that are able to self-report their pain level using a validated pain scale.
Who may be able to join
- 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
Who cannot join
- Pregnant and lactating women
- Patient with chronic malignant pain
- Patients less than 18
- Patient older than 75
- Patients with dementia
- Non-English speaking patients
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the detailed description
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
- Chronic Pain
- Being tested
- Pain Assessment
- Keywords
- chronic pain, rating scale
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain AssessmentBehavioural
To create an objective observational pain scoring system and validate.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
2 observers will use the new Chronic Pain Behavioral Scale for Adults to measure the patient's pain before a procedure to alleviate pain.
Measured: Within 3 h after an intervention designed to alleviate pain
Patient's post-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.
Measured: Within 3 h after an intervention designed to alleviate pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Eckert, Milton S. Hershey Medical Center
- Investigators
- Jill Eckert, DO, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882971
- Sponsor's protocol ID
- STUDY00003685
- Status last verified
- Feb 2019
- First submitted
- 22 Mar 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8895229Pace 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.
PubMed 33628355
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Pain Score for Chronic Pain Clinic Patients
- ClinicalTrials.gov ID
- NCT02882971
- Acronym / sponsor ID
- STUDY00003685
- Conditions
- Chronic Pain
- Keywords
- chronic pain, rating scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 Aug 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.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between the ages of 18-75 that are able to self-report their pain level using a validated pain scale.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnant and lactating women
- Patient with chronic malignant pain
- Patients less than 18
- Patient older than 75
- Patients with dementia
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 AssessmentTo create an objective observational pain scoring system and validate. | Behavioural | – |
Primary outcome
Patient's pre-procedure pain score using the Chronic Pain Behavioral Scale for Adults.
Time frame: Within 30 minutes prior to intervention designed to alleviate pain
2 observers will use the new Chronic Pain Behavioral Scale for Adults to measure the patient's pain before a procedure to alleviate pain.
Patient's pre-procedure pain score using the standard 11-point numerical rating scale.
Time frame: Within 30 minutes prior to an intervention designed to alleviate pain
The patient will be asked to rate their pain, using the standard 11-point numerical rating scale, before a procedure to alleviate pain.
2 secondary outcomes
Patient's post-procedure pain score using the Chronic Pain Behavioral Scale for Adults.
Time frame: Within 3 h after an intervention designed to alleviate pain
Patient's post-procedure pain score using the standard 11-point numerical rating scale.
Time frame: Within 3 h after an intervention designed to alleviate pain
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 7 Feb 2019.
- Background: PubMed 8895229Jensen 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.
- Derived from this study: PubMed 33628355Pace 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.
- 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.
Jill Eckert, DO principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
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 5 inclusion and 11 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Patient's pre-procedure pain score using the Chronic Pain Behavioral Scale for Adults. (time frame: Within 30 minutes prior to intervention designed to alleviate pain). 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?
On the ClinicalTrials.gov record for NCT02882971, which also lists 2 linked publications.
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 7 Feb 2019.