Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
NCT Number: NCT03847324
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Badalona, Barcelona, 08916, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Pain Education
This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.
Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Goniometric assessments of knee will be carried out to assess flexion and extension range of motion.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
4 Meters Walking Test (4MWT) will be used to evaluate patient's walking speed.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
Y Balance Test (YBT) will be use to evaluate patient's dynamic balance.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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).
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
Time frame: Baseline, 2 weeks before surgery, 1, 3 and 6 months after surgery.
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.
University of Barcelona
Other
Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty: Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05618782
Arthritis, Connective Tissue Diseases
Brno, Czechia
View Trial DetailsNCT04331158
Chronic Pain, Neurologic Manifestations
Santa Cruz, Rio Grande do Norte, Brazil
View Trial DetailsNCT03936088
Neurologic Manifestations, Osteo Arthritis Knee
Scott Air Force Base, Illinois, United States
View Trial DetailsNCT03893981
Neurologic Manifestations, Osteo Arthritis Knee
Istanbul, Bakirkoy, Turkey (Türkiye)
View Trial Details