Realigning Rehab: A Randomized Controlled Trial on Specific Exercises Versus Standard Care for Medial Knee Pain and Varus Alignment
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Oxford Knee Score (OKS)
研究概览
简要总结
Medial knee pain with varus alignment is common in active adults and is associated with increased medial joint loading, cartilage loss, and progression of knee osteoarthritis. Conventional rehabilitation typically emphasizes quadriceps strengthening and general physiotherapy, which may reduce pain and improve function but often has limited effect on abnormal frontal-plane loading and alignment in individuals with varus deformity. Targeted neuromuscular and alignment-focused exercise programs that emphasize hip and lower-limb muscle control may better address underlying biomechanical contributors to medial knee loading.
This randomized controlled trial will compare a traditional/conventional physical therapy program with a specific, alignment-focused exercise program in active adults aged 30-55 years who have medial knee pain, mild to moderate varus deformity, and Kellgren-Lawrence grade 1-3 knee osteoarthritis. Approximately 80 participants will be recruited from an outpatient setting and randomized (1:1) to receive either traditional rehabilitation or a targeted exercise protocol focusing on hip adductors and internal rotators. The supervised intervention will last 6 weeks, with follow-up assessments at 12 weeks, 6 months, and 1 year. The primary outcome is the Oxford Knee Score, with secondary outcomes including lower-extremity function, pain, quality of life, muscle strength, and radiographic alignment.
详细描述
Medial knee pain in adults with varus lower-limb alignment is a frequent presentation in orthopedic and physical therapy practice. Varus malalignment increases the medial knee adduction moment and concentrates load in the medial compartment, which is associated with greater cartilage loss, radiographic progression of knee osteoarthritis, and faster functional decline compared with neutral alignment. Prospective work has shown that higher dynamic medial knee load predicts greater medial cartilage loss over time in individuals with medial knee osteoarthritis. Conventional conservative management typically focuses on quadriceps strengthening, general lower-limb exercise, manual therapy, and activity modification. Although these approaches often reduce pain and improve function, they may not adequately address the underlying biomechanical factors related to varus alignment and medial loading.
Targeted neuromuscular and alignment-focused exercise interventions have been proposed as a way to optimize frontal-plane control and dynamic alignment of the lower limb. These programs place greater emphasis on hip adductors, abductors, and internal rotators, as well as neuromuscular training during functional tasks (e.g., squatting, stepping, and gait retraining). By improving the strength and coordination of muscles that control pelvic and femoral position, such protocols may help reduce excessive medial knee loading and improve overall joint mechanics during daily and sports activities. Previous studies in knee osteoarthritis and lower-limb malalignment populations suggest that well-designed exercise programs can yield clinically meaningful improvements in pain, function, and, in some cases, measures of alignment or dynamic loading. However, high-quality randomized controlled trials that directly compare a conventional physiotherapy program with a clearly defined, alignment-focused exercise protocol in adults with medial knee pain and varus deformity remain limited.
This trial is designed as a parallel-group randomized controlled study conducted in an outpatient setting. Active adults between 30 and 55 years of age with medial knee pain, mild to moderate varus deformity on long-leg radiographs, and radiographic knee osteoarthritis graded 1-3 on the Kellgren-Lawrence scale are eligible for inclusion, provided they meet predefined anthropometric and health-status criteria and have no significant comorbid musculoskeletal or neurological conditions affecting the lower limb. The target sample size is based on an a priori power analysis to detect a moderate effect size in repeated-measures comparisons between two groups across multiple time points, with allowance for attrition to reach an enrollment goal of approximately 80 participants.
Following baseline assessment, participants will be randomly assigned in a 1:1 ratio to one of two intervention arms using a computer-generated randomization schedule with allocation concealment. The control group will receive a conventional physical therapy program consistent with usual care for medial knee pain and early medial-compartment osteoarthritis. This program typically includes quadriceps and general lower-extremity strengthening, range-of-motion and flexibility exercises, manual therapy and modalities as deemed appropriate by the treating therapist, and functional training (e.g., gait and basic task practice). Exercise dosage and progression will follow standardized guidelines, while still allowing therapists to make minor individual adjustments within the protocol framework.
The experimental group will receive a targeted exercise program that retains core elements of evidence-based knee rehabilitation but places specific emphasis on restoring dynamic alignment and frontal-plane control. The program focuses on strengthening hip adductors and internal rotators, as well as other key hip and lower-limb muscle groups that influence knee valgus-varus mechanics during weight-bearing activities. Exercises include a combination of open- and closed-chain strengthening, neuromuscular control drills, and functional retraining tasks that challenge alignment under progressively increasing load and complexity. The intervention is structured into a 6-week, clinic-based program with supervised sessions, complemented by a structured home exercise component to reinforce gains between visits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Age 30-55 years
- •BMI 18-25 kg/m²
- •Presence of medial knee pain
- •Mild to moderate varus deformity confirmed via long-leg X-ray (e.g., 2° < Hip-Knee-Ankle angle ≤ 10°)
- •Kellgren-Lawrence grade 1-3 knee osteoarthritis
- •Active adults based on REFA work classification
- •Able and willing to complete a 6-week exercise program and follow-up visits
- •Provision of written informed consent
排除标准
- •BMI > 25 kg/m²
- •History of knee surgery on the affected side
- •Any contraindication to exercise (e.g., unstable cardiovascular conditions)
- •Other significant musculoskeletal or neurological conditions affecting lower-extremity function (e.g., hip osteoarthritis, rheumatoid arthritis, peripheral neuropathy)
研究组 & 干预措施
Traditional Physical Therapy
Participants receive a conventional outpatient physical therapy program for medial knee pain and varus knee osteoarthritis. The program typically includes:
- Quadriceps and general lower-extremity strengthening
- Range-of-motion and flexibility exercises
- Functional and gait training
- Other standard modalities or manual techniques as per clinic routine Frequency and duration: supervised sessions over a 6-week period, with a home exercise component
干预措施: Conventional Knee Physical Therapy Program (Behavioral)
Targeted Exercise Program
Participants receive a specific exercise protocol focused on:
- Strengthening hip adductors and internal rotators
- Lower-limb strength and neuromuscular control aimed at improving dynamic alignment and reducing medial knee load
- Progressive closed- and open-chain exercises tailored to varus alignment The program is delivered over 6 weeks in supervised outpatient sessions with a structured home program.
干预措施: Targeted Alignment-Focused Exercise Program for Varus Knee (Behavioral)
结局指标
主要结局
Change in Oxford Knee Score (OKS)
时间窗: Baseline, 6 weeks, 3 months, and 6 months
OKS is a 12-item patient-reported outcome measure assessing knee pain and function; total score range 0-48 (higher scores indicate better status)
次要结局
- Joint-line convergence angle (JLCA)(Baseline, 1 year)
- Anatomical HKA(Baseline, 1 year)
- Change in patellar tilt angle from baseline to 1 year on 30°-45° skyline radiographs(Baseline, 1 year)
- Arithmetic HKA= MPTA - LDFA(Baseline, 1 year)
- Kellgren-Lawrence (K-L) Radiographic Grade(Baseline, 6 weeks, 3 months, 6 months)
- Lower Extremity Functional Scale (LEFS)(Baseline, 6 weeks, 3 months, 6 months)
- Numeric Pain Rating Scale (NPRS)(Baseline, 6 weeks, 3 months, 6 months)
- SF-36 Health-Related Quality of Life(Baseline, 6 weeks, 3 months, 6 months)
- Hip Muscle Strength (MMT)(Baseline and 6 weeks)
- Radiographic Alignment (HKA, mLDFA, MPTA)(Baseline, 6 weeks, 3 months, 6 months)
研究者
Mariam ibrahim
Physical Therapy Research Fellow, Assiut University, EGYPT
Assiut University
