Chronic PainNCT01390298
Pain and Function After Orthopedic Surgery
An observational study of Chronic Pain, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific explanations regarding identifying patients at risk for chronic pain after surgery and identifying mechanisms which may be altered to decrease this risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Observational
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective unicompartmental, total knee replacement or total hip replacement surgery, will be included. Patients will be American Society of Anesthesiologists physical status 1, 2, or 3.
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status 1, 2, or 3
- Scheduled for a total knee replacement or unicompartmental knee replacement
Who cannot join
- ASA >3
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific explanations regarding identifying patients at risk for chronic pain after surgery and identifying mechanisms which may be altered to decrease this risk.
This study will help investigators better understand chronic pain that develops after surgery. We are proposing to study different factors related to the surgical experience and factors in the environment to determine if any play a role in the development of chronic pain after surgery.
Read the detailed description
Primary indications for major joint surgery include limited joint function and pain. Although joint replacement or repair surgery is usually remarkably effective, in some cases pain and function are worse or not improved after surgery. Chronic pain after some surgical procedures, e.g., phantom limb pain after extremity amputation, has been long recognized, but more recent investigations suggest that chronic pain after physical injury including that of major surgery is not uncommon. The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific hypotheses regarding identifying patients at risk for chronic pain after surgery and probing mechanisms which may be manipulated to decrease this risk.
Methods:
Patients who are undergoing elective orthopedic surgery: unicompartmental knee replacement or a total knee replacement will be approached and asked to provide consent to participate in 6 months of observation after their surgery. During this time, participants will not alter their usual treatment in any way (i.e., no treatment algorithms will be altered for this study), but will complete diaries and survey instruments at numerous intervals.
Objectives:
- To demonstrate the feasibility of conducting this protocol in this clinical population. The execution of this study will allow us to identify expected enrollment rates, patient drop-out rates, and other threats to the accurate assessment of the course of pain after major joint surgery.
- To estimate the individual variability in pain trajectories over time and to obtain effect size estimates for factors that predict pain trajectory.
Interventions:
The proposed study is a prospective longitudinal observational study. All patients will complete written informed consent.
The following questionnaires will be completed:
Daily Stress Inventory Multidimensional Pain Inventory Catastrophizing Scale of the Coping Strategies Questionnaire Center for Epidemiological Studies Scale of Depression Stait-Trait Anxiety Inventory Pain Anxiety Symptom Scale Pain Medication Attitudes Questionnaire Pain Disability Index Pain Locus of Control Scale Pain Self-Efficacy Scale Marital adjustment test Job Satisfaction Survey Tampa Scale of Kinesiophobia
At Home Diary Assessments Each of the following measures listed below are programmed into an electronic diary (iPod touch) that has been especially programmed for the current study using Pendragon Forms VI.
All participants will complete the assessments in a sequence using one of several methods:
- Inpatient evaluation (surgery to discharge): Nursing staff will inquire about the patients pain levels using standard of care methods and assessment tools (e.g., numerical rating scale 0 - 10).
- Ecological Momentary assessment (discharge to day 14): The diary is programmed to emit an alarm at three random times throughout a 12-hour day (i.e., during the patients wake cycle). The patient will then have 10 minutes to complete an entry for that entry to be considered valid (i.e., waiting 2 hours to make an entry is not capturing the random assignment of assessment times).
- Once daily (day 15 to day 28): The patient is instructed to complete a diary entry at the end of their day, just prior to going to sleep.
- Once weekly (day 29 to day 85): The patient will be called at their home and participate in a brief interview.
- Once monthly (day 86 to day 168): The patient will be called at their home and participate in a brief interview once each month.
In addition, information from the postoperative care from the orthopedic surgery division will be recorded, including range of joint motion and functional limitations, if any, at the times of routine postoperative clinic visits. The iPod touch will be returned at the postoperative visit following surgery.
Outcome measures: The primary outcome measure for this study is self-reported pain intensity. To obtain estimates of pain intensity, we will use the McGill Pain Questionnaire - Short Form (MPQ). This instrument has been extensively used to assess pain in a wide variety of settings, and is uniquely suited to our present study in that the items can be completed while in a post-operative setting as well as a daily diary setting.
- Conditions
- Chronic Pain
- Being tested
- Observational
- Keywords
- chronic pain after knee replacement surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational study only
| Study group | Role | What they receive |
|---|---|---|
| Observational | Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Pain Intensity
McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes
Visual Analog Scores were obtained during the following times:
Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168
Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation.
The change in pain over time was modeled by 7.7344 - 1.6013(log(time))
Measured: Day of hospital discharge to postoperative day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390298
- Sponsor's protocol ID
- IRB00017394
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2011
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Function After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01390298
- Acronym / sponsor ID
- IRB00017394
- Conditions
- Chronic Pain
- Keywords
- chronic pain after knee replacement surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific explanations regarding identifying patients at risk for chronic pain after surgery and identifying mechanisms which may be altered to decrease this risk.
This study will help investigators better understand chronic pain that develops after surgery. We are proposing to study different factors related to the surgical experience and factors in the environment to determine if any play a role in the development of chronic pain after surgery.
Detailed description
Primary indications for major joint surgery include limited joint function and pain. Although joint replacement or repair surgery is usually remarkably effective, in some cases pain and function are worse or not improved after surgery. Chronic pain after some surgical procedures, e.g., phantom limb pain after extremity amputation, has been long recognized, but more recent investigations suggest that chronic pain after physical injury including that of major surgery is not uncommon. The purpose of this study is to provide preliminary data for a Program Project Grant to the National Institutes of Health to examine specific hypotheses regarding identifying patients at risk for chronic pain after surgery and probing mechanisms which may be manipulated to decrease this risk.
Methods:
Patients who are undergoing elective orthopedic surgery: unicompartmental knee replacement or a total knee replacement will be approached and asked to provide consent to participate in 6 months of observation after their surgery. During this time, participants will not alter their usual treatment in any way (i.e., no treatment algorithms will be altered for this study), but will complete diaries and survey instruments at numerous intervals.
Objectives:
- To demonstrate the feasibility of conducting this protocol in this clinical population. The execution of this study will allow us to identify expected enrollment rates, patient drop-out rates, and other threats to the accurate assessment of the course of pain after major joint surgery.
- To estimate the individual variability in pain trajectories over time and to obtain effect size estimates for factors that predict pain trajectory.
Interventions:
The proposed study is a prospective longitudinal observational study. All patients will complete written informed consent.
The following questionnaires will be completed:
Daily Stress Inventory Multidimensional Pain Inventory Catastrophizing Scale of the Coping Strategies Questionnaire Center for Epidemiological Studies Scale of Depression Stait-Trait Anxiety Inventory Pain Anxiety Symptom Scale Pain Medication Attitudes Questionnaire Pain Disability Index Pain Locus of Control Scale Pain Self-Efficacy Scale Marital adjustment test Job Satisfaction Survey Tampa Scale of Kinesiophobia
At Home Diary Assessments Each of the following measures listed below are programmed into an electronic diary (iPod touch) that has been especially programmed for the current study using Pendragon Forms VI.
All participants will complete the assessments in a sequence using one of several methods:
- Inpatient evaluation (surgery to discharge): Nursing staff will inquire about the patients pain levels using standard of care methods and assessment tools (e.g., numerical rating scale 0 - 10).
- Ecological Momentary assessment (discharge to day 14): The diary is programmed to emit an alarm at three random times throughout a 12-hour day (i.e., during the patients wake cycle). The patient will then have 10 minutes to complete an entry for that entry to be considered valid (i.e., waiting 2 hours to make an entry is not capturing the random assignment of assessment times).
- Once daily (day 15 to day 28): The patient is instructed to complete a diary entry at the end of their day, just prior to going to sleep.
- Once weekly (day 29 to day 85): The patient will be called at their home and participate in a brief interview.
- Once monthly (day 86 to day 168): The patient will be called at their home and participate in a brief interview once each month.
In addition, information from the postoperative care from the orthopedic surgery division will be recorded, including range of joint motion and functional limitations, if any, at the times of routine postoperative clinic visits. The iPod touch will be returned at the postoperative visit following surgery.
Outcome measures: The primary outcome measure for this study is self-reported pain intensity. To obtain estimates of pain intensity, we will use the McGill Pain Questionnaire - Short Form (MPQ). This instrument has been extensively used to assess pain in a wide variety of settings, and is uniquely suited to our present study in that the items can be completed while in a post-operative setting as well as a daily diary setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalAdult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective unicompartmental, total knee replacement or total hip replacement surgery, will be included. Patients will be American Society of Anesthesiologists physical status 1, 2, or 3.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist (ASA) physical status 1, 2, or 3
- Scheduled for a total knee replacement or unicompartmental knee replacement
Key exclusion criteria (1 listed)
- ASA >3
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 |
|---|---|---|
| ObservationalObservational study only | Other | Observational |
Primary outcome
Self-reported Pain Intensity
Time frame: Day of hospital discharge to postoperative day 168
McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes Visual Analog Scores were obtained during the following times: Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168 Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation. The change in pain over time was modeled by 7.7344 - 1.6013(log(time))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
James C Eisenach, M.D. principal investigator
Wake Forest University Health Sciences
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 Wake Forest University 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 2 inclusion and 1 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 19 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Pain Intensity (time frame: Day of hospital discharge to postoperative day 168). 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 19 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.