Structured Rehabilitation Program for Patients With Total Knee Replacement

Study Overview
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Brief Summary
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This study will be a randomized controlled trial. This study will be conducted in Horizon Hospital Lahore. A sample size of 26 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with Structured Rehabilitation program along with conventional physiotherapy while Group B will be treated with conventional physiotherapy only. Both groups will receive treatment for 4 weeks,3 sessions per week. The outcome measures Numeric pain rating scale(NPRS),6 minutes' walk test and Womac scale will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25.

Detailed Description
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Total knee replacement (TKR) is the most common, gold standard surgical intervention in relieving pain, improving physical functions and quality of life in end-stage osteoarthritis.An estimated 25-47% of patients who are eligible for primary joint replacement in the United Kingdom have isolated unicompartmental osteoarthritis, and would be eligible to receive either implant. Adequate post-operative pain control in TKR patients is very important as inadequate pain control can lead to delayed mobilization, prolonged hospital stay, deep vein thrombosis with embolic events, increased psychological stress thereby increasing morbidity and mortality of TKR patients.Physiotherapy, principally exercise prescription and gait re- education, is advocated for people after THR and TKR.Surgeons are particularly concerned regarding cementless implants, given they rely on press fit fixation in the surrounding bone for primary stability.Patients undergoing total knee arthroplasty often have unfulfilled expectations from the surgery that can lead to dissatisfaction.Patients have a poor understanding of outcomes related to total knee replacement (TKR) surgery, with most patients underestimating the potential benefits and overestimating the risk of complications.To prevent chronic pain after TKR, several perioperative interventions show benefits and merit further research. Enhanced Recovery After Surgery (ERAS) has been successfully adopted across a range of procedures with using rehabilitation program. This study will focus on effects of structured rehabilitation program of 4 weeks with different goals in each week for reducing pain and improving function in patients with knee osteoarthritis. Study will provide a structured rehabilitation program for the physiotherapist to achieve all goals in three phases (protective, Recovery & Activity phase). AP Antony-Leo 2019 in this RCT study improvements occurred by following structured rehabilitation care,quality of life and joint specific outcomes through medial parapatellear approach.Andrew David Beswick. In TKR to prevent chronic pain, showing benefits by using several perioperative interventions.In this systematic review the patients with osteoarthritis achieve long term outcomes after TKR by using perioperative interventions. In evidence base review enhanced recovery after surgery had already been used successfully in various surgical specialities. This evidence-based review provides an insight into the best evidence linked to each component and their rationale for inclusion in the proposed enhanced recovery after surgery protocol. Arijit Goshi 2019. In this evidence base review enhanced recovery programmes require a multidisciplinary team of dedicated professionals, principally involving preoperative education, multimodal pain control and accelerated rehabilitation; this will be enhanced if combined with minimally invasive surgery. The current economic environment and restricted healthcare budget further necessitate brief hospitalisation while minimising costs.MS Ibrahim 2019.C.E.H Scott 2019. The patient satisfaction rate of 81.4 % at 12 month in this study is comparable to other studies.In this prospective study it is important to clear that whether dissatisfaction is a consequence of surgical technique, implant design, patient selection, or counselling and the management of expectation. This study provided knowledge about to help patient selection and counselling. Soren T.Sku 2019 in an RCT study in patients with knee osteoarthritis who were eligible for total knee replacement, treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 month as compared to nonsurgical treatment.Literature shows that postoperative rehabilitation for total knee replacement is of prime importance and improves postoperative outcomes and it would be more beneficial to divide outcome goals in phases so as to achieve these goals according to week wise distribution

Official Title
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Effects of Structured Rehabilitation Program on Pain and Function in Patients With Total Knee Replacement

Conditions
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Knee

Intervention / Treatment
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* Other: Structured Rehabilitation Program
* Other: Conventional Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient with unilateral or bilateral total knee replacement through medial parapatellar approach. Exclusion Criteria: Patients awaiting revision TKR Post traumatic patients planned for TKR Those with non-degenerative joint diseases Patients got infected after operation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Structured rehabilitation program<br>Structured rehabilitation program & conventional physical therapy | Other: Structured Rehabilitation Program<br>* Early Function Phase (Protective phase) week 1 Progressive Function Phase (Recovery Phase) 2nd and 3rd week Advance Function Phase (Activity Phase) 4th week<br>Other: Conventional Physical Therapy<br>* • Rapid post-operative mobilization • Range of motion exercises started • Passive extension by placing pillow under foot • Flexion-by dangling the leg over the side of bed • Muscle strengthening exercises • Weight bearing is allowed on 1st post-operative<br>|
| Active Comparator: conventional physical therapy<br>conventional physical therapy | Other: Conventional Physical Therapy<br>* • Rapid post-operative mobilization • Range of motion exercises started • Passive extension by placing pillow under foot • Flexion-by dangling the leg over the side of bed • Muscle strengthening exercises • Weight bearing is allowed on 1st post-operative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95). The test-retest reliability of this scale is recorded to be 0.96. (Hawker et al. 2011) | 4th week | 
| 6 Minute walk test | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions. Main strengths of the 6 MWT stem from its simplicity in concept and performance, low cost, ease of standardization, and acceptance by test subjects, including those who are deconditioned, elderly, or frail. | 4th week | 
| WOMAC SCALE | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0- 20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. | 4th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee pain, knee Replacement, Degenerative knee disease