Complex Regional Pain Syndrome I (CRPS I)ABILITIES-1NCT05998889
Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
A study testing Experimental group in people with Complex Regional Pain Syndrome I (CRPS I), run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome I (CRPS I)
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No difficulties understanding Spanish or Catalan.
- Diagnosed according to Budapest criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CAP El Maresme
Mataró, Barcelona, 08304
Jordi Alcaide Altet, PT, 666703823, jordi.alcaide@uvic.cat
About this study
Official title: A Feasibility Study of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
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.
Read more
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),
- Being tested
- Experimental group, Control group
- Keywords
- Complex Regional Pain Syndrome, Physiotherapy (specialty), Pain Management, Exposure Therapy, Efficacy, Safety
- Medical subject headings
- Complex Regional Pain Syndromes, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Education, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain
Control groupBehavioural
Graded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: GPE+GMI | Experimental | Pain Education program based on Neuroscience of pain and the Fear-Avoidance model + Graded Pain Exposure Exercises + Graded Motor Imagery Receives: Behavioral: Experimental group |
| Control group: GMI | Active comparator | Graded Motor Imagery Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weekly during during the intervention (9 weeks)
Secondary outcomes (9)
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Jan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome I (CRPS I)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Principal investigator, Jordi Alcaide Altet, University of Vic - Central University of Catalonia
- Investigators
- Jordi Alcaide Altet, PT, Principal investigator, University of Vic - UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998889
- Sponsor's protocol ID
- ABILITIES-1
- Acronym
- ABILITIES-1
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shafiee E, MacDermid J, Packham T, Walton D, Grewal R, Farzad M. The Effectiveness of Rehabilitation Interventions on Pain and Disability for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis. Clin J Pain. 2023 Feb 1;39(2):91-105. doi: 10.1097/AJP.0000000000001089.
PubMed 36650605Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.
PubMed 35687369Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.
PubMed 35579382Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8.
PubMed 28596288van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.
PubMed 21474244
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
- ClinicalTrials.gov ID
- NCT05998889
- Acronym / sponsor ID
- ABILITIES-1 / ABILITIES-1
- Keywords
- Complex Regional Pain Syndrome, Physiotherapy (specialty), Pain Management, Exposure Therapy, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: GPE+GMI | Experimental | Behavioral: Experimental groupPain Education program based on Neuroscience of pain and the Fear-Avoidance model + Graded Pain Exposure Exercises + Graded Motor Imagery |
| Control group: GMI | Active comparator | Behavioral: Control groupGraded Motor Imagery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No difficulties understanding Spanish or Catalan.
- Diagnosed according to Budapest criteria.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupEducation, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain | Behavioural | Intervention group: GPE+GMI |
| Control groupGraded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency. | Behavioural | Control group: GMI |
Primary outcome
Severity of the disease
Time frame: 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 1: oedema
Time frame: 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 2: pain
Time frame: 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 3: temperature
Time frame: 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.
Safety outcome 4: range of motion
Time frame: 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.
9 secondary outcomes
Quality, Intensity and location of pain
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Pain pressure level
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Conditioned Pain Modulation
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Upper limb function
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Lower limb function
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Quality of life (EQ-5D-5L)
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Catastrophism
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Self-efficacy
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Strength
Time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 36650605Shafiee E, MacDermid J, Packham T, Walton D, Grewal R, Farzad M. The Effectiveness of Rehabilitation Interventions on Pain and Disability for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis. Clin J Pain. 2023 Feb 1;39(2):91-105. doi: 10.1097/AJP.0000000000001089.
- Background: PubMed 35687369Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.
- Background: PubMed 35579382Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.
- Background: PubMed 28596288Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8.
- Background: PubMed 21474244van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Alcaide Altet, PT principal investigator
University of Vic - UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Complex Regional Pain Syndrome I (CRPS I), run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Alcaide Altet, PT (+34 666703823, jordi.alcaide@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of the disease (time frame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998889, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.