An interventional study of Experimental group and Control group in Complex Regional Pain Syndrome I (CRPS I), sponsored by University of Vic - Central University of Catalonia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by University of Vic - Central University of Catalonia · Not applicable, Interventional, and Treatment
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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),
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 26 is below the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →University of Vic - Central University of Catalonia is the lead sponsor of 38 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Pain Education program based on Neuroscience of pain and the Fear-Avoidance model + Graded Pain Exposure Exercises + Graded Motor Imagery
Behavioral: Experimental group
Graded Motor Imagery
Behavioral: Control group
Education, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain
Graded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency.
Severity of the disease
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).
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Safety Outcome 1: oedema
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.
Time frame: Weekly during during the intervention (9 weeks)
Safety Outcome 2: pain
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.
Time frame: Weekly during during the intervention (9 weeks)
Safety Outcome 3: temperature
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.
Time frame: Weekly during during the intervention (9 weeks)
Safety outcome 4: range of motion
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.
Time frame: Weekly during during the intervention (9 weeks)
Quality, Intensity and location of pain
Mc-Gill Short Form Questionnaire : It is a self-administered questionnaire consisting of 15 descriptors, of which 11 are sensory categories and 4 are affective. Each pain descriptor contains four columns representing the categories 0: none, 1: mild, 2: moderate, and 3: severe. Participants must mark the level of descriptor that represents their pain. There is no cutoff score in the questionnaire; higher values indicate more pain. Additionally, the questionnaire includes a visual analog scale of pain, which is a validated and reliable metric for pain assessment
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Pain pressure level
Pain Pressure Threshold: Measured using a handheld pressure algometer (PAIN TEST™ FPX 50). Algometry has shown excellent interexaminer reliability (ICC 0.91). Pressure pain thresholds will be assessed on the dorsal side at 2 local points and one away from the hand; the local points are located at the proximal interphalangeal joint of the third finger (point 1) and at the space between the first and second metacarpals (point 2). Additionally, dorsally at the middle third of the forearm (point 3), the mean values of three consecutive measurements will be taken and compared to the contralateral side. For the lower extremity, two local points will be assessed on the foot and one at a distance; the local points are located at the metatarsophalangeal joint of the 1st (point 4) and 5th toes on the dorsal side of the foot (point 5), and the distant point is the Anterior Tibial Tuberosity of the same leg (point 6).
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Conditioned Pain Modulation
Cold Pressure Test; The experimental tonic pain will be induced by submerging the contralateral hand in cold water following the Cold Pressor Test (conditioning stimulus), and the assessment of pressure pain thresholds (test stimulus) will be performed before and during the application of the conditioning stimulus using a handheld algometer. The Cold Pressor Test (CPT) has shown to be a superior conditioning stimulus to pain by ischemia and is widely used to evaluate conditioned pain modulation. The CPT will involve keeping the contralateral hand submerged in water at 12±1ºC up to the wrist for a period of 2 minutes. The assessment of pressure pain thresholds will begin 45 seconds after immersion; the locations will be local to the affected extremity; for the upper extremity will be performed at point 2, and for the lower extremities at point 4.
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Upper limb function
Upper limb function will be analyzed using the Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scale. This questionnaire consists of 11 items, with a minimum of 10 items needed to be validly completed. It assesses the difficulty in performing daily activities, work-related tasks, social or family relationships, as well as pain and difficulty sleeping on a Likert scale ranging from 1 (no difficulty/problem) to 5 (unable/extremely difficult pain). The average of the responses is calculated, subtracting 1 from the total, and then multiplied by 25 to obtain a percentage related to the degree of disability, where higher values indicate greater disability. The QuickDASH has shown excellent test-retest reliability assessed by Lin's concordance coefficient of 0.80 and internal consistency greater than 0.9.
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Lower limb function
Foot and Ankle Ability Measure: (FAAM) scale will be used. This 29-item questionnaire assesses the physical function of individuals with foot or ankle-related disabilities. It consists of two subscales: the first one with 21 items evaluates activities of daily living (ADLs), and the second one with 8 items assesses sports activities. Higher scores indicate better function. Each item is scored on a 5-point Likert scale ranging from 0 (unable to perform) to 4 (no difficulty), with the option to answer N/A (not applicable) in case the activity is limited by any other aspect not related to the foot or ankle. The FAAM scale demonstrates high internal consistency (Cronbach's α for ADLs 0.97 and for sports 0.93) and test-retest reliability for ADLs (ICC=0.90) and for sports (ICC=0.76)
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Quality of life (EQ-5D-5L)
EQ-5D-5L questionnaire: The EuroQoL 5 dimensions 5 levels questionnaire assesses quality of life through five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L has demonstrated efficacy, reliability, and discriminative ability in multiple pathologies and populations. Users evaluate their perception of each dimension at the moment of assessment and have five Likert-type options ranging from 1 ("no problems") to 5 ("extreme problems"). The questionnaire also includes a Visual Analog Scale (VAS) for perceived quality of life. The set of values is categorized into a 5-digit code. The VAS is marked with a cross, and it indicates the perceived health status on that particular day.
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Catastrophism
Pain Catastrophizing Scale (PCS). The PCS is a self-administered questionnaire that assesses the construct of "Pain Catastrophizing" in response to the modulation of painful stimuli. It consists of 13 items that assess three different dimensions: rumination (items 8, 9, 10, 11), magnification (items 6, 7, 13), and helplessness (items 1, 2, 3, 4, 5, 12). The PCS shows reliable test-retest parameters (0.79) and internal consistency (Cronbach's α of 0.84)
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Self-efficacy
Self-efficacy in Chronic Pain Questionnaire: this questionnaire assesses three dimensions with 22 items: self-efficacy in symptom control (items 1-8), self-efficacy in physical functioning (items 9-17), and self-efficacy in pain management (items 18-22). Each question is scored from 0 ("not at all capable") to 10 ("completely capable"), with a range of values from 0 to 100. The questionnaire has a test-retest reliability of r=0.75 and internal consistency (Cronbach's α of 0.91).
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Strength
Hand-grip strength measured with a dynamometer: isometric handgrip strength will be calculated on the affected side using a JAMAR hydraulic dynamometer, while seated with a straight back and feet touching the ground. The elbow is flexed at a 90° angle, in a neutral position of forearm pronation and supination, close to the body, with a neutral wrist position, and in the most comfortable device position for the user (42). The user will be instructed to squeeze the device as hard as possible upon verbal command. Three measurements will be taken with 5 seconds of rest between each. The test-retest reliability of the handgrip strength measurement with this dynamometer is very high (r=0.88-0.93)
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Plan to share: No
Start is estimated for Jan 2024; primary completion for Dec 2024, 11 months later.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 11 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
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University of Vic - Central University of Catalonia