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Complex Regional Pain Syndrome (CRPS) / Complex Regional Pain Syndrome (CRPS) is a chronic neurological disorder that affects the extremities and is characterized by disabling pain, swelling, vasomotor instability, sudomotor abnormality, and impaired motor function; the duration and clinical magnitude is greater than expected, being divided into three stages of progression over time: Stage I: acute (0-3 months); Stage II: dystrophic (3-9 months); Stage 3: atrophic (9-18 months).
The purpose of this study is to investigate the effect on complex pain syndrome using a conventional care protocol plus the application of non-invasive neuromodulation during compared to the effect of the same protocol plus placebo.
The design of this study is a randomised, triple blind clinical trial with placebo control.
The size of the sample will be 42 participants who come to referral hospitals. They will be randomized in two groups: control or experimental.
The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.
The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive Neuromodulation | Experimental | Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
|
| Placebo Non-invasive Neuromodulation | Placebo Comparator | Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Neuromodulation | Device | The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain ( VAS) | The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable". | Up to 6 month |
| Quick Dash Test | The Quick DASH Upper Extremity Rating Scale for Upper Extremity can be completed by the patient in aid of the orthopedic surgeon. It consists of 11 items that assess the presence of symptoms and the functional capacity of the individual surveyed during the last week. A total of 11 questions must be answered for the questionnaire to calculate the functional situation accurately | Up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle balance | The Daniels scale or Daniels test is a tool used to measure the strength of muscles in the human body, especially in patients with neuromuscular disorders or localized injuries. the scale itself follows a specific numbering, with six well-differentiated levels from 0 to 5. These are the following: 0: the muscle does not contract, complete paralysis.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aníbal Báez-Suárez, PhD | Contact | +34 652077692 | anibal.baez@ulpgc.es | |
| Aníbal Báez-Suárez, PhD | Contact | +34652077692 | anibal.baez@ulpgc.es |
| Name | Affiliation | Role |
|---|---|---|
| Aníbal Báez-Suárez, PhD | University of Las Palmas de Gran Canaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aníbal Báez Suárez | Recruiting | Las Palmas de Gran Canaria | Palmas, Las | 35016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22022040 | Result | Sebastin SJ. Complex regional pain syndrome. Indian J Plast Surg. 2011 May;44(2):298-307. doi: 10.4103/0970-0358.85351. | |
| 12595868 | Result | Wasner G, Schattschneider J, Binder A, Baron R. Complex regional pain syndrome--diagnostic, mechanisms, CNS involvement and therapy. Spinal Cord. 2003 Feb;41(2):61-75. doi: 10.1038/sj.sc.3101404. |
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| ID | Term |
|---|---|
| D012019 | Reflex Sympathetic Dystrophy |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
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|
| Up to 6 month |
| Sleep quality | The Medical Outcomes Study Sleep Scale questionnaire will be used. This instrument was designed to obtain subjective information on the quality and quantity of sleep in the last 4 weeks. It is composed of 12 Likert-type items with 6 degrees of response (from 1-always to 6-never) and grouped into the following categories:
For its interpretation, a gross estimate of the amount of sleep is obtained (item 2) and scores in the different subscales. The direct scores are transformed into a scale from 0 to 100, with no cut-off points; the higher the score, the greater the intensity of the concept evaluated. | Up to 6 month |
| 23171669 | Result | Todorova J, Dantchev N, Petrova G. Complex regional pain syndrome acceptance and the alternative denominations in the medical literature. Med Princ Pract. 2013;22(3):295-300. doi: 10.1159/000343905. Epub 2012 Nov 16. |
| 20693883 | Result | Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38. |
| 27134626 | Result | Ratti C, Nordio A, Resmini G, Murena L. Post-traumatic complex regional pain syndrome: clinical features and epidemiology. Clin Cases Miner Bone Metab. 2015 Jan-Apr;12(Suppl 1):11-6. doi: 10.11138/ccmbm/2015.12.3s.011. Epub 2016 Apr 7. |
| 12749974 | Result | Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4. |
| 28961359 | Result | Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29. |
| 18346583 | Result | Albazaz R, Wong YT, Homer-Vanniasinkam S. Complex regional pain syndrome: a review. Ann Vasc Surg. 2008 Mar;22(2):297-306. doi: 10.1016/j.avsg.2007.10.006. |
| D009468 | Neuromuscular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |