Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pain Exposure Physical Therapy Or Conservative Therapy for Patients With Complex Regional Pain Syndrome Type I
Brief Summary: The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.


Options:
A: Inclusion criteria

* Subject is ≥ 18 years of age at time of informed consent;
* Subjects have been diagnosed with predominant, chronic, intractable back pain with a VAS \> 50 mm (on a 100-mm scale);
* Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation;
* Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
* Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
* Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
* Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses;
* Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
* Subject is male or non-pregnant female;
* Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a clinical psychologist and principal investigator, using face-to-face encounters and the psychological testing described in the measures;
* Patient is capable of giving informed consent.

Exclusion criteria

* Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
* Unresolved malignancies in the last six months;
* Subject has post-herpetic neuralgia (shingles);
* Subject has an active systemic infection or is immune-compromised;
* Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
* Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
* Bleeding complications or coagulopathy issues;
* Pregnant/lactating or not using adequate birth control;
* A life expectancy of less than one year;
* Any active implanted device whether turned off or on;
* A previous SCS experience;
* Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
B: Inclusion Criteria:

* signed informed consent
* treated with spinal cord stimulation
* stable pain relief achieved

Exclusion Criteria:

* failure to give informed consent
* unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
C: Inclusion Criteria:

* Visual Analogue Scale (VAS) of pain is higher than 40 mm.
* Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

* Malignancy within the past 2 years.
* Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
D: Inclusion Criteria:

Patients between 18 and 80 years of age with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria between 3 and 24 months after initial injury will be selected for the study.

Exclusion Criteria:

Patients who do not comply with the inclusion criteria especially those who have other causes that may explain a pain syndrome will be excluded (IASP criterium)

Answer: D