Evaluation Of The Effectiveness Of Prism Adaptation Therapy In Patients With Complex Regional Pain Syndrome (CRPS) Type I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Complex Regional Pain Syndrome (CRPS) is a clinical condition characterized by pain that arises either without an identifiable triggering factor or with a severity disproportionate to the initiating event. Its progression is typically unpredictable, and most therapeutic interventions yield only partial efficacy. Prism Adaptation Therapy (PAT) is a sensorimotor training method traditionally employed to mitigate attentional deficits in post-stroke hemispatial neglect and has recently been explored as a treatment modality for CRPS. Preliminary non-blinded studies with small patient cohorts have demonstrated its potential to reduce pain and related symptoms. The present study aims to assess the effects of prism adaptation therapy administered during the acute phase on pain intensity and other clinical outcomes in CRPS, addressing the considerable challenges associated with managing chronic pain in this disorder.
详细描述
A total of 54 patients diagnosed with Complex Regional Pain Syndrome (CRPS) type 1, in accordance with the Budapest diagnostic criteria and fulfilling the inclusion and exclusion criteria, were enrolled in this study. Utilizing the sealed-envelope method, participants were randomized into two equal groups: 27 patients assigned to the prism adaptation therapy group and 27 to the control group. The control group received standard physical therapy and rehabilitation interventions supplemented by a pointing protocol administered once daily over 20 sessions under the supervision of the same physician/physiotherapist, with the use of neutral-lens goggles. Conversely, the prism adaptation therapy group underwent the identical pointing protocol employing prismatic-lens goggles in conjunction with standard physical therapy and rehabilitation interventions.
Baseline data collection prior to randomization included demographic characteristics such as age (years), sex (female/male), marital status (married/single), occupation, educational level, living arrangement, and alcohol and tobacco consumption. Clinical and disease-related baseline variables were also recorded, comprising height (cm), body weight (kg), body mass index (kg/m²), comorbidities, and current medication regimens. The etiology or inciting event(s) were documented, including fracture, surgery, immobilization, and casting. For fracture-related cases, detailed information on fracture pattern, intra-articular involvement, casting, surgical intervention, type and duration of immobilization, and the interval from the inciting event(s) to presentation at the physical medicine and rehabilitation outpatient clinic was noted. Furthermore, CRPS-associated signs and symptoms-including pain, edema, color changes, temperature alterations or asymmetry, sweating changes, nail and hair abnormalities, involuntary movements, tremor, weakness, and limitations in hand and wrist range of motion-were assessed at baseline. Sensory evaluations encompassed hyperalgesia testing with cotton wool and allodynia assessment using a 22-gauge black-tipped needle.
All patients were evaluated at three time points: baseline prior to treatment initiation (T0), immediately following treatment completion (T1), and six weeks post-treatment (T2). Assessments included clinical parameters, standardized evaluation tests, and ultrasonographic examinations.
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 (Participant)
盲法说明
Participants wore either prismatic-lens goggles or neutral-lens goggles during the pointing protocol. Both interventions were described as potentially beneficial.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 75 years
- •Patients diagnosed with CRPS Type 1 according to the IASP 2003 CRPS Budapest diagnostic criteria
- •Presence of traumatic etiologies, including surgical procedures, fractures, or immobilization
- •Patients who consented to participate and provided written informed consent
排除标准
- •History of inflammatory, autoimmune, hematologic, or neoplastic diseases
- •Diabetes mellitus, thyroid disorders, hepatic or renal failure
- •History of cranial trauma or cranial surgery within the preceding 6 months
- •Use of diuretics, anti-inflammatory, antineoplastic, corticosteroid, immunosuppressive, antidepressant, or anxiolytic medications within the past 2 months
- •Use of anticholinergic medications within the past 7 days
- •Active ocular infection, inflammation, allergy, or recent use/exposure to ophthalmic drops
- •History of lens or ocular surgery within the last 3 months
- •Current or previous use of glasses or contact lenses, or diagnosis of refractive error ≥0.5 diopters
- •Peripheral nerve injury in the affected hand consistent with CRPS Type 2 as per Budapest criteria
- •Known progressive or non-progressive peripheral or central nervous system disorders
- •CRPS Type 1 developing subsequent to central nervous system injury (e.g., stroke)
- •Patients in the acute phase following primary or secondary tendon repair
- •Presence of comorbid conditions likely to impair functionality and health-related quality of life, such as decompensated heart failure, chronic kidney failure, or malignancy
- •Comorbid diseases affecting hand function, including rheumatoid arthritis, psoriatic arthritis, or other inflammatory disorders involving the hand
- •Joint restriction and/or muscle weakness in the affected extremity that would impede movement
- •History of acute upper-extremity deep vein thrombosis or arterial thrombosis
- •Arterial or venous injury and/or history of arterial or venous repair surgery
- •History of heavy alcohol consumption or inappropriate opioid use
- •Inadequately treated psychiatric disorders or conditions, such as major depression, anxiety, or schizophrenia
- •Recurrent diagnosis of CRPS Type 1, defined as patients experiencing repeated episodes
研究组 & 干预措施
Prism Adaptation Therapy Group
The prism adaptation therapy intervention group
干预措施: The Prism Adaptation Therapy Group (Device)
Control Group
The control group that will undergo the protocol using sham goggles
干预措施: The Control Group (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline, post-treatment (Week 4), and follow-up (Week 10)
The visual analog scale (VAS) is an instrument used to quantify pain intensity. It can be presented in either a vertical or horizontal orientation. Patients are asked, "If 10 represents the worst pain imaginable and 0 represents no pain, how much pain are you experiencing at this moment?" The scale consists of a 100-mm straight line on which patients indicate the severity of their symptoms. The left endpoint is typically labeled "no pain," while the right endpoint is labeled "worst pain imaginable." Patients mark the point on the line that best corresponds to their perceived pain level. The distance from the left endpoint to the marked point is then measured and recorded as the pain score.
LANNS
时间窗: Baseline, post-treatment (Week 4), and follow-up (Week 10)
The LANSS is employed to evaluate neuropathic pain. It comprises five pain-related questions and two sensory assessments.In the sensory assessment section, allodynia and pin-prick sensation are examined. A score of 12 or above indicates that the pain is likely neuropathic in nature. The maximum total score is 24.
次要结局
- Evaluation of Joint Range of Motion(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Light Touch Sensation(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Grip and Lateral Pinch Strength(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Measurement of Wrist Circumference(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Hand and Wrist Volume(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Evaluation of Manual Dexterity(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Functional Status in Activities of Daily Living (ADL)(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Disability(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Quality of Life(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Assessment of Kinesiophobia(Baseline, post-treatment (Week 4), and follow-up (Week 10))
- Ultrasonographic Assessment(Baseline, post-treatment (Week 4), and follow-up (Week 10))
研究者
AYŞE ELİF ŞEN AKALIN
Physical Medicine and Rehabilitation Specialist
Ankara Etlik City Hospital