ClinicalTrials.gg
CompletedNCT01390298Updated Feb 19, 2019Results posted

Pain and Function After Orthopedic Surgery

An observational study in Chronic Pain, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Wake Forest University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
18 Years and older
Sex
All
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Study 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.

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:

A. 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).

B. 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).

C. 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.

D. Once weekly (day 29 to day 85): The patient will be called at their home and participate in a brief interview.

E. 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.

02

Conditions studied

  • Chronic Pain

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Keywords

  • chronic pain after knee replacement surgery
03

In context

Chronic Pain

2,999 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 55 is below the median of 128 across 706 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Wake Forest University is the lead sponsor of 118 studies on the registry; 7 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • American Society of Anesthesiologist (ASA) physical status 1, 2, or 3
  • Scheduled for a total knee replacement or unicompartmental knee replacement

Exclusion criteria

Exclusion Criteria:

  • ASA >3
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Observational

    Adult patients scheduled for elective unicompartmental or total knee replacement surgery or total hip replacement will be consented to participate

    Other: Observational

Interventions

  • OtherObservational

    Observational study only

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What researchers measure

Primary outcomes

  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))

    Time frame: Day of hospital discharge to postoperative day 168

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Results

Posted Feb 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneAll Study Participants
Started55
Completed31
Not completed24
Withdrew: Death1
Withdrew: Long term icu admission1
Withdrew: Withdrawal by subject14
Withdrew: Lost to follow-up7
Withdrew: Surgery cancelled1

Outcome measures

PrimarySelf-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))

Time frame:
Day of hospital discharge to postoperative day 168
Reported as:
Mean · units on a scale
Self-reported Pain Intensity
units on a scaleAll Study Participants
Self-reported Pain Intensity3 ± 2.9

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Observational1/31 (3.2%)1/31 (3.2%)1/31 (3.2%)
Most frequent serious events
Most frequent serious events
EventObservational
Subject experienced myocardial infarction during the immediate postoperative periodCardiac disorders1/31
Most frequent other events
Most frequent other events
EventObservational
Subject experienced postoperative complications resulting in long term hospitializatonGeneral disorders1/31

Baseline characteristics

Analysis population is based on the 40 participants that were initiated into the study after signing the informed consent. 55 Consented and 14 withdrew after signing consent and 1 withdrew because surgical procedure canceled leaving a total of 40 participants that completed baseline questionnaires.

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years26
>=65 years14
Age, Continuous
Age, Continuous(years)All Study Participants
Mean60.35 (32 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female22
Male18
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American8
White32
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United States40
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Study locations

1 site
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 23, 2012
  • Informed consent form · Mar 28, 2013

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2011 to primary completion in Dec 2012, 17 months.

Results were first posted in Feb 2019, 6 years 2 months after primary completion.

Of 325 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 17 months is below that.

Counting every sponsor, half of 350 studies reached it within 25 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2011
First posted
Jul 11, 2011
StartActual
Jul 2011
Primary completionActual
Dec 2012
CompletionActual
May 2017
Results first posted
Feb 19, 2019
Last update
Feb 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01390298
Responsible party
Sponsor
First posted
Jul 11, 2011
Start date
Jul 2011
Primary completion
Dec 2012
Completion
May 2017
Results posted
Feb 19, 2019
Last update
Feb 19, 2019

Study contacts

James C Eisenach, M.D.
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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