Osteoarthritis, Rehabilitation
Conditions
Keywords
Arthritis, Degenerative, Recovery of function
Brief summary
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the exercises given in brochures, and in the study group a schedule will be given in order to record rehabilitation exercises in patients after total knee replacement (TKA). Both groups will be assessed before and after surgery, together with outpatient follow-up by, WOMAC, Visual Analogue Scale and OKS (Oxford Knee Score).
Detailed description
Osteoarthritis (OA) is the most common rheumatic disease worldwide. OA cause joint pain and occupational disability in the adult population. In Mexico, OA is one of the top ten reasons of consultation in primary attention care. Joint arthroplasty is a major advance in the treatment of chronic joint pain. It is indicated in patients in whose conservative medical therapy has failed. Total knee arthroplasty (TKA) is a surgery that reduces pain and improves function and quality of life in patients with knee disorders, actually is one of the most successful medical procedures. However, a critical consideration in patients with TKA is the successful control of postoperative pain. An adequate pain control allows faster rehabilitation, reduces complications and is highly correlated with patient satisfaction. A multimodal pain management decreases the use of narcotics, improve pain scores, increase patient satisfaction and allows early recovery. Regarding postoperative rehabilitation, its suggested that rehabilitation programs are based on a biopsychosocial philosophy and integrate exercises and self-management interventions are effective in the treatment of osteoarthritis. Rehabilitation therapy an important area that should be considered. It helps people recover faster from their illness, injury or medical procedures and make possible to get back to their daily activities. The World Health Organization describes rehabilitation as a process that aims to enable people to maintain and achieve their physical, sensory, intellectual, functional, psychological and social level in an optimal way. It is known that rehabilitation involves contributions from various health disciplines, including physical therapy and occupational therapy and offered in inpatient, outpatient and community patients. In patients with total knee replacement, rehabilitation interventions may involve education and exercise before surgery, early mobilization while being in the hospital and a postoperative program, along with an adequate pain management. Perioperative care has shown an improvement in the recovery, it reduces hospital day stay, convalescent and risk of postoperative medical complications. It has been shown that early initiation of rehabilitation within 24 hours after total knee arthroplasty reduces in-hospital time and decreases the number of sessions required to achieve autonomy, balance and normal gait. Madsen et al. demonstrated that rehabilitation exercises at home have the same effect as those made in rehabilitation group within six months postoperatively, based on a study of 80 patients randomly divided into a control- study group. Optimal pain management is vital seeking to achieve the goal of recovery called fast track. It involves early therapy with specialized protocols, early discharge and quick recovery. Lamplot et al. demonstrated in a prospective randomized study of 36 patients, using this method, a decrease in opioid consumption and its adverse effects, a decreased pain score, a shortening time for physical therapy and an increase in patient satisfaction. Postoperative analgesia can be achieved by a variety of techniques. These include: intravenous analgesia, epidural analgesia, techniques for peripheral nerve block and periarticular injections. All aim to control pain in patients and provide the better satisfaction. Integrating these interventions in a clinical pathway, better functional results are obtained, hospital stay is reduced and there is an improvement in the patient's recovery, mainly in short-term.
Interventions
OTHERSchedule
Illustrative daily planner to point the day that the exercise was performed
OTHERVerbal Information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 90 years * Patients with Knee osteoarthritis (OA) grade 4 ( Kellgren-Lawrence based on radiographic findings) * Total Knee Arthroplasty (TKA) for primary OA * Rapid rehabilitation desire
Exclusion criteria
* Age \<18 and \> 90 years * Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings) * Patients with asociated Rheumatic syndromes * Patients with anticoagulant therapy * Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections * Drugs abuse history * Physiatric disease * Pregnant patients * Patients with hemoglobin values \< 11g/dl , platelets \< 150,000/ μL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total WOMAC Score | up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months) | The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (Measure of Pain Intensity) | up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months) | The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (scale of 10). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months) | The Oxford Knee Score is a 12-item patient-reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. Consists of 12 multiple choice questions consisting of five answers with a maximum score of 60. Score ranges * Score 0 to 19: May indicate severe knee arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon. * Score 20 to 29: May indicate moderate to severe knee arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon. * Score 30 to 39: May indicate mild to moderate knee arthritis. Consider seeing your family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory med |
Countries
Mexico
Participant flow
Recruitment details
Recruitment was held in the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery in which the recruitment process started June 2014 until January 2019. The objective was to recruit 76 patients were randomly divided into two groups.
Pre-assignment details
6 patients were lost to follow up.
Participants by arm
| Arm | Count |
|---|---|
| Control - Verbal Information and Booklet Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the | 28 |
| Study - Verbal Information, Booklet & Schedule. Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the | 42 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Total | Study - Verbal Information, Booklet & Schedule. | Control - Verbal Information and Booklet |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 28 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 14 Participants | 8 Participants |
| Knee right or left Left Knee | 32 participants | 18 participants | 14 participants |
| Knee right or left Right Knee | 38 participants | 24 participants | 14 participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 34 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 36 Participants | 20 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 42 |
| other Total, other adverse events | 0 / 28 | 0 / 42 |
| serious Total, serious adverse events | 0 / 28 | 1 / 42 |
Outcome results
Primary
Total WOMAC Score
The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.
Time frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Verbal Information and Booklet | Total WOMAC Score | 2 weeks | 39.60714286 score on a scale | Standard Deviation 18.01920639 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 6 weeks | 25.32142857 score on a scale | Standard Deviation 16.60444735 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 0 weeks | 51.64285714 score on a scale | Standard Deviation 17.26957137 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 6 months | 10.28571429 score on a scale | Standard Deviation 7.721337165 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 4 weeks | 29.42857143 score on a scale | Standard Deviation 13.48916869 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 12 months | 6.571428571 score on a scale | Standard Deviation 6.941173833 |
| Control - Verbal Information and Booklet | Total WOMAC Score | 3 months | 16 score on a scale | Standard Deviation 11.18861856 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 12 months | 9.166666667 score on a scale | Standard Deviation 7.525296094 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 3 months | 20.19047619 score on a scale | Standard Deviation 11.89842805 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 0 weeks | 52.47619048 score on a scale | Standard Deviation 20.96947619 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 2 weeks | 40.38095238 score on a scale | Standard Deviation 16.73458866 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 4 weeks | 30.85714286 score on a scale | Standard Deviation 14.35197178 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 6 weeks | 24.88095238 score on a scale | Standard Deviation 14.11140756 |
| Study - Verbal Information, Booklet & Schedule. | Total WOMAC Score | 6 months | 14.11904762 score on a scale | Standard Deviation 8.969330891 |
Secondary
Visual Analog Scale (Measure of Pain Intensity)
The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (scale of 10).
Time frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 12 months | 0.678571429 score on a scale | Standard Deviation 0.944911183 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 6 weeks | 3 score on a scale | Standard Deviation 2.388242807 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 2 weeks | 5.392857143 score on a scale | Standard Deviation 2.114137346 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 3 months | 2.214285714 score on a scale | Standard Deviation 2.266619981 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 0 weeks | 8.178571429 score on a scale | Standard Deviation 1.906199854 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 6 months | 1.428571429 score on a scale | Standard Deviation 1.687175405 |
| Control - Verbal Information and Booklet | Visual Analog Scale (Measure of Pain Intensity) | 4 weeks | 4 score on a scale | Standard Deviation 1.943650632 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 12 months | 0.761904762 score on a scale | Standard Deviation 1.225929688 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 0 weeks | 8.285714286 score on a scale | Standard Deviation 1.8251056 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 2 weeks | 5.714285714 score on a scale | Standard Deviation 2.051599189 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 4 weeks | 4.261904762 score on a scale | Standard Deviation 2.012879551 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 6 weeks | 3.333333333 score on a scale | Standard Deviation 2.385593618 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 3 months | 2.619047619 score on a scale | Standard Deviation 2.197031045 |
| Study - Verbal Information, Booklet & Schedule. | Visual Analog Scale (Measure of Pain Intensity) | 6 months | 1.785714286 score on a scale | Standard Deviation 1.746574547 |
Other Pre-specified
Oxford Knee Score (OKS)
The Oxford Knee Score is a 12-item patient-reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. Consists of 12 multiple choice questions consisting of five answers with a maximum score of 60. Score ranges * Score 0 to 19: May indicate severe knee arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon. * Score 20 to 29: May indicate moderate to severe knee arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon. * Score 30 to 39: May indicate mild to moderate knee arthritis. Consider seeing your family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory med
Time frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 4 weeks | 28.5 units on a scale | Standard Deviation 5.666666667 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 3 months | 36.89285714 units on a scale | Standard Deviation 6.020577588 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 2 weeks | 22.60714286 units on a scale | Standard Deviation 7.568645291 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 6 months | 38.78571429 units on a scale | Standard Deviation 7.067699835 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 6 weeks | 32 units on a scale | Standard Deviation 7.693190832 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 12 months | 41.21428571 units on a scale | Standard Deviation 5.902649392 |
| Control - Verbal Information and Booklet | Oxford Knee Score (OKS) | 0 weeks | 17.10714286 units on a scale | Standard Deviation 6.436811298 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 12 months | 40.54761905 units on a scale | Standard Deviation 4.357233296 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 0 weeks | 17.45238095 units on a scale | Standard Deviation 8.554566263 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 2 weeks | 21.35714286 units on a scale | Standard Deviation 7.367765749 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 4 weeks | 25.90243902 units on a scale | Standard Deviation 7.059762312 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 6 weeks | 30.02380952 units on a scale | Standard Deviation 7.202601479 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 3 months | 33.54761905 units on a scale | Standard Deviation 6.868813868 |
| Study - Verbal Information, Booklet & Schedule. | Oxford Knee Score (OKS) | 6 months | 37.42857143 units on a scale | Standard Deviation 5.926965485 |