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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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:

  1. 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.
  2. 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:

  1. 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).
  2. 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).
  3. 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.
  4. Once weekly (day 29 to day 85): The patient will be called at their home and participate in a brief interview.
  5. 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 groups in NCT01390298
Study groupRoleWhat they receive
ObservationalAdult 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.

  1. 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.

  1. First posted11 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionDec 2012
  4. Study completionMay 2017

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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