Clinical trial NCT04694625: Structured Rehabilitation Program for Patients With Total Knee Replacement
Official title: Effects of Structured Rehabilitation Program on Pain and Function in Patients With Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee
Keywords: Knee pain
knee Replacement
Degenerative knee disease
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4th week
measure: 6 Minute walk test
timeFrame: 4th week
measure: WOMAC SCALE
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Horizon Hospital Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Saima Zahid, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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