Total Knee ReplacementNCT03231566
Pain Neuroscience Education in Total Knee Arthroplasty
A study testing Pain Neuroscience Education in people with Total Knee Replacement, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Pain Neuroscience Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2015to 20 Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA
Who cannot join
- Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas - Department of Physical Therapy
Las Vegas, Nevada, 89154
About this study
Official title: A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty
To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery
Read the detailed description
To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.
- Conditions
- Total Knee Replacement
- Being tested
- Pain Neuroscience Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationBehavioural
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Usual education control group (CG) | Active comparator | The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information. Receives: Behavioral: Pain Neuroscience Education |
| Experimental group (EG) | Experimental | The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA. Receives: Behavioral: Pain Neuroscience Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Numeric Pain Rating Scale
Measured: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Function
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Pain Catastrophization
Pain Catastrophization Scale
Measured: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Fear of movement
Tampa Scale of Kinesiophobia
Measured: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Secondary outcomes (3)
Opioid Use
Oral Morphine Dose Equivalents
Measured: Change at 1 month
Healthcare Expenses
Costs associated with healthcare utilization
Measured: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Patient Satisfaction
Likert questions
Measured: Change at 1 month, 3 months and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start28 Feb 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231566
- Sponsor's protocol ID
- 710848-3
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- 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 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03231566
- Acronym / sponsor ID
- 710848-3
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 28 Feb 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery
Detailed description
To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual education control group (CG) | Active comparator | Behavioral: Pain Neuroscience EducationThe CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information. |
| Experimental group (EG) | Experimental | Behavioral: Pain Neuroscience EducationThe EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA
Key exclusion criteria (1 listed)
- Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.
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 Neuroscience EducationSee arm/group description | Behavioural | Experimental group (EG), Usual education control group (CG) |
Primary outcome
Pain
Time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Numeric Pain Rating Scale
Function
Time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain Catastrophization
Time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Pain Catastrophization Scale
Fear of movement
Time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Tampa Scale of Kinesiophobia
3 secondary outcomes
Opioid Use
Time frame: Change at 1 month
Healthcare Expenses
Time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Patient Satisfaction
Time frame: Change at 1 month, 3 months and 6 months post-surgery
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 27 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education in people with Total Knee Replacement, run by University of Nevada, Las Vegas 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 1 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 27 Jul 2017. 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?
Pain (time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery). The study lists 4 primary outcomes in all. 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 27 Jul 2017.