A Feasibility Study of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Safety Outcome 2: pain
研究概览
简要总结
Background:
There is low quality evidence supporting the use of rehabilitation in Complex Regional Pain Syndrome (CRPS), despite it is the first line approach in the Guidelines . Graded Motor Imagery (GMI) may be useful to improve pain and function at mid term (6 months). Graded Pain Exposure Approaches (GPE) seem to improve pain but not function at mid term. In other type of chronic pain conditions GPE offers better outcomes than "pain contingent" (exercises avoiding pain) approaches at short term (3 months) and similar at mid term. Following the recommendations of Authors, we will evaluate the efficacy and safety of a combined therapy of GMI and GPE in people with CRPS type 1.
Objective:
To evaluate the feasibility of a combined therapy of GPE and GMI in front of only GMI in people with CRPS-1 and the clinical impact on the primary outcome (Severity of the disease) of the intervention.
Design:
Feasibility Randomized controlled Trial, single blind of evaluator, 2 parallel arms. Measurement pre-intervention, post-intervention , 1 and 3 months follow-up.
Population:
People 18 years old or above with CRPS type 1 diagnosed by Budapest criteria and (1) without any psychological or psychiatric disease, (2) nor any neurosensorial issue that could compromise the realization of the therapy proposed (3) neither any major surgery intervention related to CRPS (e.g neurostimulation or sympathectomy) (4) nor minor intervention on the last 3 months (e.g. nerve blocks).
Outcomes:
Primary outcomes: Complex Regional Pain Syndrome Severity Scale (severity of the disease) and Safety Outcomes ( oedema, pain, temperature, Range of Motion). Secondary outcomes: 5Q-5D-5L (quality of life), SF-MPQ (Quality, Intensity and location of pain), PPT (pain pressure threshold), CPM ( pain inhibition pathways), FAAM or Quick Dash (function), PCS (catastrophism), Self efficacy in chronic pain questionnaire (self-efficacy), Dynamometry (Hand Grip strength),
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No difficulties understanding Spanish or Catalan.
- •Diagnosed according to Budapest criteria.
排除标准
- •Diagnosis of psychological or psychiatric illness
- •Having received any major invasive treatment (e.g: Spinal cord Implants or sympathectomy of the affected extremity).
- •Having received any minor invasive treatment (e.g: Nerves block) in the last three months.
- •Having any neurosensorial difficulty that could compromise the execution of the therapy proposed.
结局指标
主要结局
Safety Outcome 2: pain
时间窗: Weekly during during the intervention (9 weeks)
Changes in Verbal Pain Numerical Rating Scale after the exercises (recorded verbally). Control before and after the intervention. Registered in a dichotomous way, absence if no changes observed, presence if the Pain has raised 2 points or more.
Safety Outcome 1: oedema
时间窗: Weekly during during the intervention (9 weeks)
Perimetry ( measured with a measuring tape in centimeters ) of the metacarpofalangical joint line of the affected hand or the metatarsofalangical joint line of the affected foot. Control before and after the exercise intervention. Registered in a dichotomous way, absence if no changes observed, presence if the perimeter has raised 2 centimeters or more.
Safety outcome 4: range of motion
时间窗: Weekly during during the intervention (9 weeks)
Changes in active Range of Motion (measured with a finger goniometer in degrees). Control before and after the exercise intervention. Registered in a dichotomous way, absence if no changes observed, presence if active range of motion decreases 10º or more.
Severity of the disease
时间窗: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Complex Regional Pain Syndrome Severity Score: This questionnaire contains self-reported items of persistent disproportionate pain, allodynia /hyperalgesia, asymmetry of temperature, color, sweating, oedema, trophic changes and motor changes . It also includes items observed by the examiner: allodynia , hyperalgesia , bilateral asymmetry of temperature by palpation, skin color changes, sweating, edema, trophic changes , and motor changes , as well as a decrease in active joint range of motion. The items are evaluated dichotomously; 0 indicates absence, and 1 indicates presence, resulting in a possible score range of 0 to 16, where higher scores indicate greater severity. The internal consistency obtained for the 16 items was adequate (Cronbach's α = 0.71).
Safety Outcome 3: temperature
时间窗: Weekly during during the intervention (9 weeks)
Changes in temperature (in Celsius Degrees, taken with a Hand Infrared thermometer). Control before and after the exercise intervention at 1 cm in the center of the back of the affected hand / foot and compared to the other side. Registered in a dichotomous way, absence if no changes observed, presence if the temperature raises 2ºC or more.
次要结局
- Quality, Intensity and location of pain(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Pain pressure level(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Conditioned Pain Modulation(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Lower limb function(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Quality of life (EQ-5D-5L)(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Upper limb function(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Catastrophism(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Self-efficacy(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
- Strength(Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.)
研究者
Jordi Alcaide Altet
Principal investigator, physiotherapist
University of Vic - Central University of Catalonia