Effects of Different Vibration Applications on Bone Turnover Markers and Functionality After Total Knee Arthroplasty in Women With Osteopenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) Test Score
研究概览
简要总结
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major global public health problem, with the knee joint being the most commonly affected site. Treatment modalities include exercise, diet, oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and total knee arthroplasty (TKA). TKA is indicated in cases of severe pain, functional loss, deformity, and limited range of motion when conservative methods are no longer effective. However, some patients may continue to experience deformity and functional deficits after surgery. Postoperative quadriceps weakness and decreased functional capacity can negatively affect patient prognosis.
Following TKA, bone mineral density (BMD) tends to decrease during the first three months. The reduction in BMD and the increase in bone resorption may elevate the risk of implant loosening or periprosthetic fracture. Bone turnover markers (BTMs), which are enzymes or degradation products released into circulation by bone cells, reflect bone remodeling processes and can help identify increased fracture risk.
A significant proportion of TKA candidates are osteopenic. Since osteopenic individuals make up a larger segment of the population, most fragility fractures actually occur in individuals with osteopenia rather than osteoporosis. Therefore, BMD levels and the presence of osteopenia or osteoporosis should be taken into account in patients undergoing TKA.
To preserve both bone quality and muscle mass, early rehabilitation and progressive weight-bearing on the operated limb are considered essential. These strategies may improve both BMD and BTMs. Whole-body vibration (WBV) therapy has been suggested as an effective and safe method to increase mechanical loading on the bones. WBV can be applied in a static standing position on a vibration platform or combined with simultaneous exercise.
Given the limited availability of targeted strategies to improve bone remodeling and BTMs after TKA, and the lack of clarity regarding the optimal WBV protocol, this study aims to investigate the effects of different vibration applications on bone turnover markers, functionality, muscle strength, pain intensity, pressure pain threshold, range of motion, proprioception, edema, and muscle biomechanical properties in osteopenic women following TKA.
Participants will be randomly assigned to one of three groups: WBV only, WBV combined with exercise (WBV-E), or control. All groups will receive traditional rehabilitation three times per week for four weeks after surgery. WBV interventions will begin at the end of the fourth postoperative week, once patients are deemed ready. While WBV groups will receive additional vibration therapy, the control group will continue traditional rehabilitation alone.
Outcomes will be evaluated using bone turnover markers, the Timed Up and Go (TUG) test, the 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), measurements of muscle biomechanical properties and strength, pain intensity and pressure pain threshold, joint range of motion, proprioception, and edema.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo unilateral, primary, cemented total knee arthroplasty (TKA) using a posterior cruciate ligament-sacrificing technique and medial parapatellar approach due to knee osteoarthritis
- •Ability to speak and understand Turkish
- •Ability to comprehend both verbal and written information
- •A T-score between -2.5 and -1 (i.e., -2.5 < T-score < -1) measured by DXA in the lumbar spine, total hip, or femoral neck within the past year
排除标准
- •Scheduled for revision TKA
- •American Society of Anesthesiologists (ASA) physical status classification score higher than 3
- •History of major surgery on the limb to be operated
- •Presence of comorbid diseases such as rheumatoid arthritis or cancer
- •Presence of a neurological condition causing functional impairment
- •Diagnosed psychiatric disorder
- •Disorders affecting the vestibular system
- •Having undergone anesthesia for any reason within the last month
- •Regular use of hypnotic or anxiolytic medications
- •Hearing or vision impairment not correctable by hearing aids or glasses
- •Presence of endocrine system disorders
- •Secondary osteoporosis or history of osteoporotic fracture
- •Metabolic bone diseases or chronic illnesses potentially affecting bone metabolism
- •Use of medications known to affect bone metabolism (e.g., menopausal hormone therapy, bisphosphonates, raloxifene, calcitonin, growth hormone, parathyroid hormones, corticosteroids) within 6 months prior to the start of the study
研究组 & 干预措施
Whole Body Vibration
Participants in this group will receive whole body vibration (WBV) in addition to the standard postoperative rehabilitation program. WBV will be applied 3 times per week. In the first week, 1 set of 5-minute static standing WBV will be administered at a low frequency (8 Hz) and amplitude (2 mm). In subsequent weeks, progression will be applied based on participant tolerance. The frequency will increase gradually up to 30-40 Hz, and the amplitude up to 5 mm, with a total WBV duration of up to 15 minutes per session. Participants will stand upright with equal weight distribution on both feet during vibration. No concurrent exercise will be performed during WBV.
干预措施: Whole Body Vibration Therapy (Behavioral)
Whole Body Vibration with Exercise (WBV-E)
In this group, participants will receive whole body vibration (WBV) simultaneously with lower extremity exercises performed on a vibrating platform. After exercise training is demonstrated on a stable surface, participants will perform the exercises on the platform. WBV will be initiated with low amplitude (2 mm) for the first two weeks and increased to 5 mm by the third week depending on pain tolerance. Frequency will be maintained between 30-40 Hz. Exercises will include lunge steps, shallow squats, dynamic squats, toe raises, and ball squeezes between the knees (2-3 kg medicine ball). Vibration duration will progress from 2 minutes (3 exercises × 30 sec) to a maximum of 18 minutes (6 exercises × 60 sec × 3 sets). One-minute rest will be provided between sets and repetitions. Total session duration will vary between 45 and 70 minutes.
干预措施: Whole Body Vibration with Exercise (Behavioral)
Control
Participants in this group will receive only the standard postoperative rehabilitation program and an individualized home exercise plan. The conventional rehabilitation protocol includes exercises with rest periods of 1 minute between sets and repetitions. The average initial session duration will be approximately 45 minutes, progressing to 60-70 minutes in later sessions. No vibration intervention will be administered.
干预措施: Conventional Physiotherapy (Behavioral)
结局指标
主要结局
Timed Up and Go (TUG) Test Score
时间窗: Baseline (Week 4 post-op) and 12th week (Post-intervention)
This test evaluates functional mobility and performance-based activity limitation. Participants are instructed to stand up from a standardized chair (height: 44 cm; depth: 26 cm), walk 3 meters at a normal pace, turn around, return, and sit down. The time taken to complete the task is recorded. The TUG test is a valid and reliable indicator of physical function in individuals with knee osteoarthritis.
Bone Turnover Marker (Serum Procollagen Type I N-terminal Propeptide (PINP) Level)
时间窗: Pre-surgery, Week 4, Week 12
Serum PINP levels will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone formation activity. Results will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at three time points: pre-surgery, week 4 post-surgery, and week 12 post-surgery
Bone Turnover Marker (Serum Osteocalcin (OCN) Level)
时间窗: Pre-surgery, Week 4, Week 12
Serum concentration of Osteocalcin (OCN )will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone turnover. Units will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at 3 time points: pre-surgery, week 4, and week 12 post-surgery.
Bone Turnover Marker (Serum C-terminal Telopeptide of Type I Collagen (CTX) Level)
时间窗: Pre-surgery, Week 4, Week 12
C-terminal Telopeptide of Type I Collagen (CTX) concentrations will be analyzed using enzyme-linked immunosorbent assay (ELISA) to evaluate bone resorption. Results will be expressed in nanograms per milliliter (ng/mL). Serum will be collected at three time points: before surgery, and at 4 and 12 weeks after surgery.
Bone Turnover Marker (Serum N-terminal Telopeptide of Type I Collagen (NTX) Level)
时间窗: Pre-surgery, Week 4, Week 12
N-terminal Telopeptide of Type I Collagen (NTX) will be measured with enzyme-linked immunosorbent assay (ELISA) kits to assess bone resorption activity. Results will be expressed in nanomoles of bone collagen equivalents per liter (nmol BCE/L), according to kit instructions. Samples will be drawn at three time points: pre-surgery, week 4, and week 12 post-surgery.
30-Second Chair Stand Test
时间窗: Week 4 and Week 12
Participants are asked to cross their arms over their chest and stand up from a 44 cm standard chair as many times as possible within 30 seconds. The number of correct repetitions is recorded to assess lower limb functional strength and endurance.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Week 4 and Week 12
The WOMAC index evaluates pain, stiffness, and physical function through 24 items scored from 0 to 4. Higher scores indicate greater impairment.
Muscle Strength (Isometric)
时间窗: Week 4 and Week 12
Maximum isometric knee extension (quadriceps) strength will be assessed using a Lafayette digital dynamometer with standardized seated positioning (hip 90°, knee 60° flexion). The average of three trials will be recorded in Newton.
Pain Pressure Threshold (PPT)
时间窗: Week 4 and Week 12
Pressure pain threshold will be assessed using a 10-anatomical point digital pressure algometer (J-TECH-USA Commander) that has shown excellent relative and absolute reliability in knee osteoarthritis. Measurements will be recorded in kilogram-force (kg). The average value of the 10 anatomical points will be used for analysis.
次要结局
- Pain Intensity (Visual Analog Scale)(Week 4 and Week 12)
- Knee Range of Motion (ROM)(Week 4 and Week 12)
- Proprioception (Joint Position Sense)(Week 4 and Week 12)
- Knee Edema Volume(Week 4 and Week 12)
- Biomechanical Muscle Properties (Muscle Tone of Quadriceps)(Week 4 and Week 12)
- Biomechanical Muscle Properties (Muscle Stiffness of Quadriceps)(Week 4 and Week 12)
- Biomechanical Muscle Properties (Muscle Elasticity of Quadriceps)(Week 4 and Week 12)
- Biomechanical Muscle Properties (Muscle Relaxation Time of Quadriceps)(Week 4 and Week 12)
- Biomechanical Muscle Properties (Muscle Creep of Quadriceps)(Week 4 and Week 12)