The Short-Term Impact of Manual Traction Combined With Standard Rehabilitation Protocol on Pain, Function, and Quality of Life After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The goal of this clinical trial is to determine whether the addition of manual traction to a standard rehabilitation protocol improves early recovery after primary total knee arthroplasty (TKA) in women aged 50-75 years with knee osteoarthritis.
The main questions it aims to answer are:
- Does the addition of manual traction reduce postoperative pain during the first four weeks after TKA?
- Does manual traction improve physical function, knee range of motion, patient-reported knee function, and health-related quality of life compared with standard rehabilitation alone?
- Does manual traction reduce the need for analgesic medication during the early postoperative rehabilitation period?
Researchers will compare participants receiving manual traction plus standard rehabilitation with participants receiving sham traction plus the same standard rehabilitation protocol to determine whether manual traction provides additional clinical benefits during early rehabilitation after TKA.
Participants will:
- Be randomly assigned to either the manual traction group or the sham traction (control) group.
- Receive a standardized rehabilitation program for four weeks after surgery, with the intervention group receiving manual traction and the control group receiving sham traction.
- Attend supervised rehabilitation sessions five times per week throughout the four-week intervention period.
- Complete validated questionnaires assessing pain, knee function, joint awareness, and health-related quality of life at predefined assessment time points.
- Undergo standardized clinical assessments of knee range of motion and physical function before surgery, before rehabilitation, during follow-up, and one month after surgery.
- Have their analgesic medication use recorded throughout the rehabilitation period.
详细描述
Total knee arthroplasty (TKA) is one of the most effective surgical procedures for managing end-stage knee osteoarthritis. Despite advances in surgical techniques and postoperative care, many patients continue to experience pain, reduced range of motion, impaired physical function, and delayed recovery during the early postoperative period. Early rehabilitation is therefore essential to optimize functional outcomes, promote independence, and improve health-related quality of life.
Standard rehabilitation following TKA typically includes pain management, therapeutic exercises, gait training, progressive weight-bearing, and functional mobility training. Although these interventions are effective, additional manual therapy techniques may further enhance postoperative recovery by reducing pain, improving joint mobility, and facilitating functional performance.
Manual traction is a passive joint distraction technique designed to decrease compressive forces across the tibiofemoral joint, improve joint mobility, and reduce pain. While manual traction has demonstrated beneficial effects in patients with knee osteoarthritis and other musculoskeletal disorders, evidence regarding its effectiveness during the early rehabilitation period after TKA remains limited. High-quality randomized controlled trials investigating this intervention in the postoperative setting are scarce.
This randomized, double-blind, sham-controlled clinical trial aims to evaluate the effectiveness of adding manual traction to a standardized rehabilitation protocol during the first four postoperative weeks following primary TKA. Participants will be randomly allocated to receive either manual traction combined with standard rehabilitation or sham traction combined with the same rehabilitation program. Participant and outcome assessor blinding will be implemented to minimize performance and assessment bias, while the treating physiotherapist will not participate in outcome assessment because blinding of the therapist is not feasible.
Detailed Description - The study is designed to determine whether the addition of manual traction provides clinically meaningful improvements during early postoperative recovery. The findings are expected to provide evidence regarding the effectiveness of manual traction as an adjunct to standard rehabilitation and may contribute to the optimization of postoperative physiotherapy protocols following primary total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation. Participant blinding will be maintained through the use of sham traction in the control group. Due to the nature of the intervention, the treating physiotherapist cannot be blinded and will not be involved in outcome assessment.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 50 and 75 years.
- •Patients who will undergo primary total knee arthroplasty due to osteoarthritis, classified as Kellgren-Lawrence grades 3 to
- •Patients willing to participate in the study and able to provide informed consent.
排除标准
- •Morbid obesity, defined as a body mass index (BMI) greater than 40 kg/m².
- •Revision arthroplasty procedures.
- •Presence of severe cardiac, vascular, renal, neurological, psychiatric, or other orthopedic conditions affecting the lower limb and limiting functional abilities.
- •Active infections or contraindications to physical therapy.
- •Inability to comply with the prescribed rehabilitation protocol.
结局指标
主要结局
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
时间窗: Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
次要结局
- Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)(Pre-treatment and at the fourth postoperative week.)
- Knee range of motion(Baseline (preoperative), pre-treatment, and at the fourth postoperative week.)
- Timed Up and Go Test (TUG)(At the fourth postoperative week.)
- Joint Perception Measured by the Forgotten Joint Score-12 (FJS-12)(At 4 weeks after surgery.)
- Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)(Before surgery (baseline) and at 4 weeks after surgery.)
- Two-Minute Walk Test (2MWT)(At 4 weeks after surgery.)
- Single-Leg Stance Test (SLST)(At 4 weeks after surgery.)
- Five Times Sit-to-Stand Test (5xSTS)(At 4 weeks after surgery.)
研究者
Mimozë Zogaj
Doctoral Candidate
Alma Mater Europaea - Slovenia