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Near-infrared spectroscopy in cold type Complex Regional Pain Syndrome

Near-infrared spectroscopy in cold type Complex Regional Pain Syndrome - NIRS in CRPS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42462
Enrollment
64
Registered
2015-10-29
Start date
2015-08-03
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletspier metabolisme en doorbloeding bij koude complex regionale pijnsyndroom Complex regional pain syndrome Reflex Sympathetic Dystrophy Syndrome (RSDS) Sudeck's atrophy

Interventions

Both groups will receive a venous and arterial occlusion during the measurements to determine the muscle blood flow and oxygen consumption respectively.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients with the diagnosis cold unilateral CRPS of an upper or lower limb according to the Budapest Research Criteria (not applicable in Controls): Continuing pain, which is disproportionate to any inciting event Must report at least one symptom in three of the four following categories: Sensory: reports of hyperesthesia and/or allodynia Vasomotor: reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry Sudomotor/edema: reports of edema and/or seating changes and/or sweating asymmetry Motor/trophic: reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin) Must display at least one sign at time of evaluation in two or more of the following categories: Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement) Vasomotor: evidence of temperature asymmetry with the affected side being >= 1° colder than the unaffected side. Sudomotor/edema: evidence of edema and/or sweating changes and/or sweating asymmetry Motor/trophic: evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin). There is no other diagnosis that better explains the signs and symptoms. - Age >= 18 years - Able to provide written informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Known history of peripheral arterial disease (PAD) or suspicion of PAD at intake - Known history of Diabetes Mellitus - Other confounding neuropathic conditions i.e. paraplegia and neuropathies due to other causes than CRPS. - Coagulopathy or use of blood thinners - Use of vasoactive medications - Pregnancy

Design outcomes

Primary

MeasureTime frame
The main study parameters consist of the within person and between person difference in muscle oxygen consumption and blood flow in patients with cold type CRPS and controls. These differences are tested during rest and exercise.

Secondary

MeasureTime frame
Secondary study parameters will be: - The tissue saturation index (TSI) during rest and exercise. This is an estimate of the tissue oxygen saturation in percentage. - The rise in oxyhemoglobin during reactive hyperemia. This is measured during rest and exercise.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)