Osteoarthritis, KneeNCT03198247
Physiotherapy and Therapeutic Education After Total Knee Arthroplasty.
A study testing PNE + CST in people with Osteoarthritis, Knee, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and coping skills training (CST) to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PNE + CST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 23 Nov 2017to Jan 2020
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
- Be able to provide the informed consent.
- Be scheduled to undergo in a total knee arthroplasty.
- Knee osteoarthritis diagnosis.
- Score more than 16 points in the PCS.
- Patients between 65-80 years.
Who cannot join
- Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
- Patients scheduled to undergo in a bilateral total knee arthroplasty.
- Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
- Patients scheduled for unicompartmental knee arthroplasty.
- Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
- Co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis)
- Co-existing other mental condition and/or major depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy and Therapeutic Education in Patients With Pain Catastrophizing After a Total Knee Arthroplasty. Randomized Clinical Trial
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and coping skills training (CST) to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. There is a high evidence level of different systematic reviews, which support the efficacy of physiotherapy treatments combined with behavioural techniques aimed to reduce pain catastrophism, pain and disability in other pathologies. The primary aim of that kind of interventions is to help the subjects to reconceptualise its own pain understanding and its role on the recovery process, as well as promoting an increase of activity and encourage the subject to resume its usual activity instead of continuing to avoid it.
Read the detailed description
The prevalence of TKA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of then are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but it seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptative thoughts and behaviours (i.e. pain catastrophism, Kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.
Although many psychosocial factors have been studied, pain catastrophism has emerged as one of the most important predictors for persistent pain after a total knee arthroplasty, as well as its severity and duration, that's why it is getting more importance when it comes to study chronic pain in this subjects. Reducing pain catastrophism has become a key factor to determine the success in the rehabilitation of some maladies accompanied by pain, considering that its reduction has been associated with the clinical improvement of pain itself. It has been observed that treatments using psychological and psychosocial interventions, therapeutic education and coping skills training, or physical therapy and therapeutic exercise, are effective techniques to reduce pain catastrophism. Nevertheless, it's still necessary to determine whether the maladaptative pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Usual care, PNE + CST
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects.
The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises.
PNE + CSTOther
The PNE and CST program will be divided in 3 individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Usual Care | Active comparator | Procedure: Usual care The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects.
The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises. Receives: Other: Usual care |
| Experimental: Usual Care + PNE and CST | Experimental | Procedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. This program is mainly based in "Explain Pain" concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptative thoughts and behaviours Receives: Other: Usual care; Other: PNE + CST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life. Changes from Baseline to 6 months
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),
Measured: Baseline, 3 and 6 months after surgical intervention
Secondary outcomes (10)
Disability / limitations
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Spanish version) will be used to assess patient´s physical function. This questionnaire can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.
Measured: Baseline, 3 and 6 months after surgical intervention
Pain intensity
Participants will be asked to rate their pain on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in arthritis populations.
Measured: Baseline, 3 and 6 months after surgical intervention
Function
30-Second Chair Stand Test will be use to evaluate patient's functionality on standing, because it is a well-recognized test to detect early declines in functional independence.
Measured: Baseline, 3 and 6 months after surgical intervention
Range of Motion
Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
Measured: Baseline, 3 and 6 months after surgical intervention
Neuropathic Pain
Participants will be asked to complete Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) (Spanish version).
Measured: Baseline, 3 and 6 months after surgical intervention
Pain Catastrophizing
Participants will be asked to complete the Pain Catastrophizing Scale (PCS) (Spanish version).
Measured: Baseline, 3 and 6 months after surgical intervention
Kinesiophobia
Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version).
Measured: Baseline, 3 and 6 months after surgical intervention
Self-efficacy
Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version).
Measured: Baseline, 3 and 6 months after surgical intervention
Self-coping ability
Participants will be asked to complete the "Cuestionario de Afrontamiento ante el Dolor Crónico - Versión Reducida" (CAD-R)), a Spanish questionnaire to asses self-coping ability.
Measured: Baseline, 3 and 6 months after surgical intervention
Depression and anxiety
Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used.
Measured: Baseline, 3 and 6 months after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start23 Nov 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: low participation
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 Osteoarthritis, KneeStudies 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
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, University of Barcelona
- Responsible party
- Principal investigator, Hector Beltran-Alacreu, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198247
- Sponsor's protocol ID
- TKA-01
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochandorena-Acha M, Escriba-Salvans A, Hernandez-Hermoso JA, Terradas-Monllor M. Perioperative experiences of patients with high pain catastrophizing and knee arthroplasty after receiving or not preoperative physiotherapy: Qualitative study. Musculoskelet Sci Pract. 2024 Apr;70:102918. doi: 10.1016/j.msksp.2024.102918. Epub 2024 Feb 2.
PubMed 38330866
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy and Therapeutic Education in Patients With Pain Catastrophizing After a Total Knee Arthroplasty. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03198247
- Acronym / sponsor ID
- TKA-01
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low participation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, University of Barcelona
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 Jun 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.
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and coping skills training (CST) to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. There is a high evidence level of different systematic reviews, which support the efficacy of physiotherapy treatments combined with behavioural techniques aimed to reduce pain catastrophism, pain and disability in other pathologies. The primary aim of that kind of interventions is to help the subjects to reconceptualise its own pain understanding and its role on the recovery process, as well as promoting an increase of activity and encourage the subject to resume its usual activity instead of continuing to avoid it.
Detailed description
The prevalence of TKA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of then are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but it seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptative thoughts and behaviours (i.e. pain catastrophism, Kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.
Although many psychosocial factors have been studied, pain catastrophism has emerged as one of the most important predictors for persistent pain after a total knee arthroplasty, as well as its severity and duration, that's why it is getting more importance when it comes to study chronic pain in this subjects. Reducing pain catastrophism has become a key factor to determine the success in the rehabilitation of some maladies accompanied by pain, considering that its reduction has been associated with the clinical improvement of pain itself. It has been observed that treatments using psychological and psychosocial interventions, therapeutic education and coping skills training, or physical therapy and therapeutic exercise, are effective techniques to reduce pain catastrophism. Nevertheless, it's still necessary to determine whether the maladaptative pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Usual Care | Active comparator | Other: Usual careProcedure: Usual care The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects. The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises. |
| Experimental: Usual Care + PNE and CST | Experimental | Other: Usual care, Other: PNE + CSTProcedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. This program is mainly based in "Explain Pain" concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptative thoughts and behaviours |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
- Be able to provide the informed consent.
- Be scheduled to undergo in a total knee arthroplasty.
- Knee osteoarthritis diagnosis.
- Score more than 16 points in the PCS.
Key exclusion criteria (7 listed)
- Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
- Patients scheduled to undergo in a bilateral total knee arthroplasty.
- Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
- Patients scheduled for unicompartmental knee arthroplasty.
- Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
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 |
|---|---|---|
| Usual careThe biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects. The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises. | Other | Control Group: Usual Care, Experimental: Usual Care + PNE and CST |
| PNE + CSTThe PNE and CST program will be divided in 3 individual sessions. | Other | Experimental: Usual Care + PNE and CST |
Primary outcome
Quality of life. Changes from Baseline to 6 months
Time frame: Baseline, 3 and 6 months after surgical intervention
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),
10 secondary outcomes
Disability / limitations
Time frame: Baseline, 3 and 6 months after surgical intervention
Pain intensity
Time frame: Baseline, 3 and 6 months after surgical intervention
Function
Time frame: Baseline, 3 and 6 months after surgical intervention
Range of Motion
Time frame: Baseline, 3 and 6 months after surgical intervention
Neuropathic Pain
Time frame: Baseline, 3 and 6 months after surgical intervention
Pain Catastrophizing
Time frame: Baseline, 3 and 6 months after surgical intervention
Kinesiophobia
Time frame: Baseline, 3 and 6 months after surgical intervention
Self-efficacy
Time frame: Baseline, 3 and 6 months after surgical intervention
Self-coping ability
Time frame: Baseline, 3 and 6 months after surgical intervention
Depression and anxiety
Time frame: Baseline, 3 and 6 months after surgical intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 38330866Ochandorena-Acha M, Escriba-Salvans A, Hernandez-Hermoso JA, Terradas-Monllor M. Perioperative experiences of patients with high pain catastrophizing and knee arthroplasty after receiving or not preoperative physiotherapy: Qualitative study. Musculoskelet Sci Pract. 2024 Apr;70:102918. doi: 10.1016/j.msksp.2024.102918. Epub 2024 Feb 2.
- 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 PNE + CST in people with Osteoarthritis, Knee, run by Centro Universitario La Salle at 1 site in Spain.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 23 Jan 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Quality of life. Changes from Baseline to 6 months (time frame: Baseline, 3 and 6 months after surgical intervention). 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 NCT03198247, 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 23 Jan 2019.