Knee OsteoarthritisNCT02587429
Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty
A study testing Patient education in people with Knee Osteoarthritis, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial summary
The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Jan 2021
- 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
- Age above 18 years
- Inability to understand and communicate with the investigators
- Scheduled for an elective unilateral total knee arthroplasty
- Primary diagnosis of osteoarthritis
- Score greater than 22 or lower than 12 on the Pain Catastrophizing Scale (PCS)
Who cannot join
- Planned to undergo another elective joint replacement procedure during the 12 months period of participation
- Scheduled for revision arthroplasty surgery
- TKA surgery scheduled because of fracture, malignancy or infection
- Scheduled for Unicompartmental knee arthroplasty
- Major depression diagnosed with the Major Depression Index (MDI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after TKA. Furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.
Read the detailed description
In Denmark, are approximately 8000 patients operated annually with Knee Arthroplasty. Most of these patients will have less pain and higher functional ability after the surgery. However, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (TKA).
Research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation.
This study consists of two parts. The first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before TKA are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). In the second part the patients in control group 1 will be matched on age, BMI and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient education
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patienteducation | Experimental | (Patients with PCS>22). An education in pain coping delivered by physiotherapists. The education consist of seven sessions over a four months period. Each session is individual and will last 30 minutes. Focus will be on pain behaviour and pain coping based on Cognitive Behavioral Therapy. Receives: Behavioral: Patient education |
| Control group 1 | No intervention | (Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty. |
| Control group 2 | No intervention | (Patients with PCS<12). Patients in this arm will undergo usual treatment for total knee arthroplasty. Patients in this arm are not randomized but matched by age, gender and BMI with patients in control group 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured on a Visual Analog Scale (0-100)
Measured: 12 months
Secondary outcomes (10)
Six-minute Walk Test
Measured: 12 months
Sit-to-stand in 30 seconds
Measured: 12 months
EuroQol (EQ-5D)
Measured: 12 months
Pain Catastrophizing Scale
Measured: 12 months
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 12 months
Short Form 36 (Physical Function)
Measured: 12 months
Dual Energy X-ray Absorptiometry (DXA) scan
To detect muscle mass
Measured: 12 months
Tri-axial-accelerometer
To measure physical activity for seven days
Measured: 12 months
Oxford Knee Score
Measured: 12 months
Pain Self-Efficacy Questionnaire (PSEQ)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Birch, Regional Hospital West Jutland
- Investigators
- Torben B Hansen, professor,MD, Study director, University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587429
- Sponsor's protocol ID
- VEK 1-10-72-64-15
- Status last verified
- Jan 2020
- First submitted
- 23 Oct 2015
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Birch S, Stilling M, Mechlenburg I, Hansen TB. Effectiveness of a physiotherapist delivered cognitive-behavioral patient education for patients who undergoes operation for total knee arthroplasty: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Mar 21;18(1):116. doi: 10.1186/s12891-017-1476-6.
PubMed 28320421
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02587429
- Acronym / sponsor ID
- VEK 1-10-72-64-15
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 27 Oct 2015 (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.
The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after TKA. Furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.
Detailed description
In Denmark, are approximately 8000 patients operated annually with Knee Arthroplasty. Most of these patients will have less pain and higher functional ability after the surgery. However, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (TKA).
Research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation.
This study consists of two parts. The first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before TKA are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). In the second part the patients in control group 1 will be matched on age, BMI and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patienteducation | Experimental | Behavioral: Patient education(Patients with PCS>22). An education in pain coping delivered by physiotherapists. The education consist of seven sessions over a four months period. Each session is individual and will last 30 minutes. Focus will be on pain behaviour and pain coping based on Cognitive Behavioral Therapy. |
| Control group 1 | No intervention | –(Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty. |
| Control group 2 | No intervention | –(Patients with PCS<12). Patients in this arm will undergo usual treatment for total knee arthroplasty. Patients in this arm are not randomized but matched by age, gender and BMI with patients in control group 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years
- Inability to understand and communicate with the investigators
- Scheduled for an elective unilateral total knee arthroplasty
- Primary diagnosis of osteoarthritis
- Score greater than 22 or lower than 12 on the Pain Catastrophizing Scale (PCS)
Key exclusion criteria (5 listed)
- Planned to undergo another elective joint replacement procedure during the 12 months period of participation
- Scheduled for revision arthroplasty surgery
- TKA surgery scheduled because of fracture, malignancy or infection
- Scheduled for Unicompartmental knee arthroplasty
- Major depression diagnosed with the Major Depression Index (MDI)
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 |
|---|---|---|
| Patient education | Behavioural | Patienteducation |
Primary outcome
Pain measured on a Visual Analog Scale (0-100)
Time frame: 12 months
10 secondary outcomes
Six-minute Walk Test
Time frame: 12 months
Sit-to-stand in 30 seconds
Time frame: 12 months
EuroQol (EQ-5D)
Time frame: 12 months
Pain Catastrophizing Scale
Time frame: 12 months
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 months
Short Form 36 (Physical Function)
Time frame: 12 months
Dual Energy X-ray Absorptiometry (DXA) scan
Time frame: 12 months
Tri-axial-accelerometer
Time frame: 12 months
Oxford Knee Score
Time frame: 12 months
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 28320421Birch S, Stilling M, Mechlenburg I, Hansen TB. Effectiveness of a physiotherapist delivered cognitive-behavioral patient education for patients who undergoes operation for total knee arthroplasty: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Mar 21;18(1):116. doi: 10.1186/s12891-017-1476-6.
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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.
Torben B Hansen, professor,MD study director
University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Knee Osteoarthritis, run by Regional Hospital West Jutland at 1 site in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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 Denmark. 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?
Results are not available in the source record.
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 measured on a Visual Analog Scale (0-100) (time frame: 12 months). 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 NCT02587429, which also lists 1 linked publication.
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 28 Jan 2020.