The Effectiveness of Neuromuscular Stimulation in the Rehabilitation of Operated Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Visual analog scale
研究概览
简要总结
Distal radius fractures (DRFs) are fractures affecting the wrist and occurring in the distal portion of the radius bone. DRFs can also be classified as Colles, Barton, Smith, and Hutchinson/Chauffeur fractures according to the characteristics of the fracture. The incidence of these fractures shows a bimodal distribution. In young adults, distal radius fractures occur more often as a result of high-energy traumas (e.g., traffic accidents or impacts during contact sports), while in older adults, especially during winter months, low-energy falls from standing height (falling onto an outstretched hand) are a more common cause.
详细描述
Distal radius fractures (DRFs) can be treated surgically, or conservatively with closed reduction followed by immobilization with a cast. Fractures with minimal displacement are treated conservatively in approximately one-third of cases. The standard immobilization period for DRFs is six weeks to allow for callus formation and healing of the bone and soft tissues. During plaster cast application, the standard practice is to ensure the preservation of the range of motion of the upper extremity joints above and below the cast.
Recent studies have investigated shorter immobilization periods to allow for earlier mobilization. In studies comparing plaster cast applications that can be as short as 10 days with the standard duration (approximately 6 weeks), no significant difference was found between the groups in terms of patient-reported functional outcomes, pain levels, development of Complex Regional Pain Syndrome (CRPS), secondary displacement or complications in follow-ups up to nine months after the fracture. In DRF, regardless of the treatment method, the recovery of motor functions, strength and mobility generally takes three to six months. In a small percentage of patients, mild disability and pain may persist even years after a distal radius fracture (DRF). As a result of DRF, individuals experience a decrease in wrist joint range of motion (ROM), a decrease in grip strength, impairment of hand skills (hand agility/dexterity), and an increase in pain. The main aim of rehabilitation is to eliminate these disorders using physical agents (modalities), manual therapy and exercise programs. Exercise programs include exercises aimed at improving range of motion, hand skills and muscle strength. Rehabilitation makes significant contributions to reducing functional losses, accelerating the recovery process and shortening the time individuals are away from work .Neuromuscular Electrical Stimulation (NMES) is a useful treatment method for preserving, maintaining, and restoring neuromuscular function losses resulting from disuse. One of the significant advantages of NMES is that the devices are easily purchased for individual use and can be applied at home. NMES is used in the treatment of paresis, contractures, and spasticity in the upper extremities after stroke. Studies on the upper extremities have shown that NMES application provides improvements in muscle strength, range of motion (ROM), functional performance, and cortical activation. Reduction in upper extremity spasticity and pain has also been reported. In knee osteoarthritis (OA), NMES applications have resulted in improved muscle strength and function along with reduced pain and stiffness. Furthermore, NMES applied after knee and hip replacement surgeries has been shown to increase muscle strength and functional capacity, reduce muscle atrophy, and decrease pain. Due to the positive effects of NMES on muscle strength, blood circulation, and hand edema in the early stages, this study will investigate the effects of neuromuscular stimulation on pain, grip strength, edema, range of motion, and functionality in the rehabilitation of operated distal radius fractures. This approach is expected to provide an innovative contribution to the classical rehabilitation protocols used in distal radius fractures.
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)
盲法说明
Outcomes Assessor is unaware of the groups.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent open reduction and volar plate surgery due to distal radius fracture (DRF) evaluated with plain radiography and CT scans.
排除标准
- •Polytrauma
- •Surgical intervention other than volar plate
- •History of surgery on the affected extremity
- •Injury to multiple anatomical sites in the affected extremity
- •Hemiplegia or contracture in the affected extremity
- •Major complications such as postoperative neurovascular injury and hematoma
研究组 & 干预措施
Neuromuscular Stimulation
Individuals in this group will receive neuromuscular stimulation in addition to the Traditional Treatment protocol.
干预措施: Neuromuscular Stimulation (Other)
Traditional Treatment
Individuals in this group will undergo passive, active-assisted, and active hand and wrist joint exercises. The exercises will be tailored to protocols reported as safe and effective in the literature.
干预措施: Traditional Exercises (Other)
Neuromuscular Stimulation
Individuals in this group will receive neuromuscular stimulation in addition to the Traditional Treatment protocol.
干预措施: Traditional Exercises (Other)
结局指标
主要结局
Visual analog scale
时间窗: Baseline
A visual analog scale will be used to evaluate the patients' current pain severity. This scale is one of the frequently preferred scales to evaluate the pain intensity of patients during rest, activity and night. The scale has a 10 cm long line where the patient can mark the intensity of pain. The patient will be asked to indicate the degree of pain intensity between no pain (left part) and unbearable pain (right part) of the line.
Visual analog scale
时间窗: 4th week
A visual analog scale will be used to evaluate the patients' current pain severity. This scale is one of the frequently preferred scales to evaluate the pain intensity of patients during rest, activity and night. The scale has a 10 cm long line where the patient can mark the intensity of pain. The patient will be asked to indicate the degree of pain intensity between no pain (left part) and unbearable pain (right part) of the line.
Edema
时间窗: Baseline
Edema measurement will be done using a thin measuring tape, measuring in figure-eight increments, and recorded in centimeters.
Edema
时间窗: 4th week
Edema measurement will be done using a thin measuring tape, measuring in figure-eight increments, and recorded in centimeters.
Grip Strength
时间窗: Baseline
The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and considered the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the AETD: seated, with shoulder adduction and neutral rotation, elbow 90 degrees flexion, forearm mid-rotation and supported, and wrist in neutral position. According to the test procedure, three consecutive measurements of hand grip strength will be taken, and the averages will be recorded in kilograms.
Grip Strength
时间窗: 4th week
The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and considered the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the AETD: seated, with shoulder adduction and neutral rotation, elbow 90 degrees flexion, forearm mid-rotation and supported, and wrist in neutral position. According to the test procedure, three consecutive measurements of hand grip strength will be taken, and the averages will be recorded in kilograms.
Pinch Strength
时间窗: Baseline
Pinch strength measurement will be performed in the standard position recommended by AETD; sitting position, shoulder in adduction and neutral rotation, elbow 90 degrees flexion, forearm in mid-rotation and supported, wrist in neutral position. According to the test procedure, 3 consecutive measurements will be taken for pinch strength and the averages will be recorded in kg.
Pinch Strength
时间窗: 4th week
Pinch strength measurement will be performed in the standard position recommended by AETD; sitting position, shoulder in adduction and neutral rotation, elbow 90 degrees flexion, forearm in mid-rotation and supported, wrist in neutral position. According to the test procedure, 3 consecutive measurements will be taken for pinch strength and the averages will be recorded in kg.
Visual analog scale
时间窗: 6th week
A visual analog scale will be used to evaluate the patients' current pain severity. This scale is one of the frequently preferred scales to evaluate the pain intensity of patients during rest, activity and night. The scale has a 10 cm long line where the patient can mark the intensity of pain. The patient will be asked to indicate the degree of pain intensity between no pain (left part) and unbearable pain (right part) of the line.
Edema
时间窗: 6th week
Edema measurement will be done using a thin measuring tape, measuring in figure-eight increments, and recorded in centimeters.
Grip Strength
时间窗: 6th week
The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and considered the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the AETD: seated, with shoulder adduction and neutral rotation, elbow 90 degrees flexion, forearm mid-rotation and supported, and wrist in neutral position. According to the test procedure, three consecutive measurements of hand grip strength will be taken, and the averages will be recorded in kilograms.
Pinch Strength
时间窗: 6th week
Pinch strength measurement will be performed in the standard position recommended by AETD; sitting position, shoulder in adduction and neutral rotation, elbow 90 degrees flexion, forearm in mid-rotation and supported, wrist in neutral position. According to the test procedure, 3 consecutive measurements will be taken for pinch strength and the averages will be recorded in kg.
次要结局
- Patient-Reported Wrist Assessment Questionnaire(Baseline)
- Patient-Reported Wrist Assessment Questionnaire(4th week)
- Patient-Reported Wrist Assessment Questionnaire(6th week)
研究者
Basak Cigdem Karacay
Principal Investigator
Kirsehir Ahi Evran Universitesi