Osteo Arthritis KneeNCT03847324
Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty
A study testing Pain Neuroscience Education and Multimodal Physiotherapy in people with Osteo Arthritis Knee and Knee Arthroplasty, run by University of Barcelona 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 multimodal physiotherapy 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 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Knee Arthroplasty, Catastrophizing
- What is being tested?
- Pain Neuroscience Education and Multimodal Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2019to 14 Mar 2023
- 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
- 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.
- Primary knee osteoarthritis diagnosis.
- Score more than 20 points in the Pain Catastrophizing Scale (PCS).
- Score more than 4 over 10 on pain Visual Analogue Scale (VAS)
- Patients older than 18 years old.
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 on Patients With Pain Catastrophism Scheduled for 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 multimodal physiotherapy 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/educational 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 maladaptive 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 maladaptive pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.
- Conditions
- Osteo Arthritis Knee, Knee Arthroplasty, Catastrophizing, Pain
- Being tested
- Pain Neuroscience Education, Multimodal Physiotherapy, Usual Care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Also called Pain Education
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 maladaptive thoughts and behaviors.
Multimodal PhysiotherapyOther
This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.
Usual CareOther
Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Group-based preoperative biomedical education, postoperative hospital and home rehabilitation. Receives: Other: Usual Care |
| PNE | Experimental | Usual care + Preoperative Pain Neuroscience Education Receives: Other: Pain Neuroscience Education; Other: Usual Care |
| Multimodal Physiotherapy | Experimental | Usual care + Preoperative Multimodal physiotherapy Receives: Other: Multimodal Physiotherapy; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain. Changes from baseline 6 months post-surgery.
Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = 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, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Secondary outcomes (10)
Range of Motion
Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Walking Speed
4 Meters Walking Test (4MWT) will be used to evaluate patient's walking speed.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Function
30-Second Chair Stand Test (30sCST) 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, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Dynamic Balance
Y Balance Test (YBT) will be use to evaluate patient's dynamic balance.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Disability / Limitation
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, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Health-related Quality of Life
The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead <0 to full health 1).
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Pain Catastrophism
The Spanish version of Pain Catastrophizing Scale (PCS) was used to asses thoughts and feelings related to pain experiences.(9) The PCS is a 13 item self-administered questionnaire composed of 3 subscales: rumination, magnification and helplessness. The PCS uses a 5-point Likert scale with responses ranging from 0 = not at all to 4 = all the time. Overall scores range from 0 to 52 points, the higher the score, the higher is the pain catastrophism level.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Depression and anxiety
Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) (Spanish version) will be used. The HADS is a 14 item self-administered questionnaire comprised of 2 subscales: depression and anxiety, both composed with 7 items. Each item use a 4-point Likert scale with responses ranging from 0 to 4. Overall scores range from 0 to 21 points for each subscales, and final score is presented using each subscale scores separately. The higher the score, the higher are the anxiety or depression levels.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Kinesiophobia
Participants will be asked to complete the Tampa Scale for Kinesiophobia (TSK-11) (Spanish version). TSK-11 is a 11 item self-administered questionnaire used to assess the pain-related fear of movement. The TSK-11 uses a 4-point Likert scale with responses ranging from 1 = totally disagree, to 4 = totally agree. Overall scores range from 11 to 44 indicating a higher degree of pain-related fear of movement when the score is higher.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Self-efficacy
Participants will be asked to complete the Chronic Pain Self-Efficacy Scale (Spanish version). The Chronic Pain Self-Efficacy Scale is a 19 item self-administered questionnaire used to asses pain-related self-efficacy. It uses a visual analog scale for each item, ranging from 0 = totally uncapable to 10 = totally capable. Overall score ranges from 0 to 190. The higher the score, the higher is the subjects' self-efficacy.
Measured: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start18 Sep 2019
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
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 Osteo Arthritis 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three armed, parallel groups, single blind, unicentric randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hector Beltran-Alacreu, PhD
- Responsible party
- Principal investigator, Marc Terradas Monllor, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847324
- Sponsor's protocol ID
- FISIOPTR-01
- Status last verified
- May 2023
- First submitted
- 18 Feb 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terradas-Monllor M, Beltran-Alacreu H, Ochandorena-Acha M, Garcia-Oltra E, Aliaga-Orduna F, Hernandez-Hermoso J. Preoperative Home-Based Multimodal Physiotherapy in Patients Scheduled for a Knee Arthroplasty Who Catastrophize About Their Pain: A Randomized Controlled Trial. J Clin Med. 2025 Jan 5;14(1):268. doi: 10.3390/jcm14010268.
PubMed 39797350
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03847324
- Acronym / sponsor ID
- FISIOPTR-01
- Conditions
- Osteo Arthritis Knee, Knee Arthroplasty, Catastrophizing, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hector Beltran-Alacreu, PhD
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 20 Feb 2019 (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 multimodal physiotherapy 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/educational 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 maladaptive 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 maladaptive 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three armed, parallel groups, single blind, unicentric randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareGroup-based preoperative biomedical education, postoperative hospital and home rehabilitation. |
| PNE | Experimental | Other: Pain Neuroscience Education, Other: Usual CareUsual care + Preoperative Pain Neuroscience Education |
| Multimodal Physiotherapy | Experimental | Other: Multimodal Physiotherapy, Other: Usual CareUsual care + Preoperative Multimodal physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- Primary knee osteoarthritis diagnosis.
- Score more than 20 points in the Pain Catastrophizing Scale (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 |
|---|---|---|
| Pain Neuroscience EducationAlso: Pain EducationThis 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 maladaptive thoughts and behaviors. | Other | PNE |
| Multimodal PhysiotherapyThis intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise. | Other | Multimodal Physiotherapy |
| Usual CareUsual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy. | Other | Multimodal Physiotherapy, PNE, Usual Care |
Primary outcome
Pain. Changes from baseline 6 months post-surgery.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = 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.
10 secondary outcomes
Range of Motion
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Walking Speed
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Function
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Dynamic Balance
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Disability / Limitation
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Health-related Quality of Life
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Pain Catastrophism
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Depression and anxiety
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Kinesiophobia
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Self-efficacy
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after 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 11 May 2023.
- Derived from this study: PubMed 39797350Terradas-Monllor M, Beltran-Alacreu H, Ochandorena-Acha M, Garcia-Oltra E, Aliaga-Orduna F, Hernandez-Hermoso J. Preoperative Home-Based Multimodal Physiotherapy in Patients Scheduled for a Knee Arthroplasty Who Catastrophize About Their Pain: A Randomized Controlled Trial. J Clin Med. 2025 Jan 5;14(1):268. doi: 10.3390/jcm14010268.
- 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 and Multimodal Physiotherapy in people with Osteo Arthritis Knee and Knee Arthroplasty, run by University of Barcelona 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 7 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: finished, as of the sponsor's last update on 11 May 2023. 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 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. Changes from baseline 6 months post-surgery. (time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.). 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 NCT03847324, 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 11 May 2023.