G90.5 G90.6
Conditions
Interventions
Group 1: Patients with CRPS of the upper or lower extremities receive vegetative reflex acupuncture at specific tender points to modulate autonomic regulatory processes.
The intervention consists of t
Sponsors
Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerzmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of CRPS 2. Minimum age of 18 3. Adequate communication skills and knowledge of German (or English, if necessary)
Exclusion criteria
Exclusion criteria: 1. Spinal conditions: fresh fractures, dislocations, acute trauma (< 3 months), tumours or metastases, severe scoliosis, structural deformities (e.g. ankylosing spondylitis), infections (spondylodiscitis), spinal surgery in the thoracic region, implants or fixations, cervical radiculopathy, severe osteoporosis 2. Skin: open wounds or skin infections on the pelvis, sacrum or in the upper thoracic region, severe adhesive plaster allergy 3. Severe cardiopulmonary conditions that do not permit prone positioning or pressure loading 4. Pregnancy 5. Relevant mental health disorders (e.g. borderline personality disorder with risk of self-harm, severe depression) 6. Neurological conditions (e.g. post-stroke condition, polyneuropathy, multiple sclerosis) 7. Cognitive impairments or language barriers that hinder understanding of the exercises or instructions 8. Current relevant substance abuse (e.g. alcohol, opioids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this pilot study, the primary endpoints relate to feasibility and safety: 1. Adherence: proportion of acupuncture sessions completed in full 2. Drop-out rate: proportion of patients who withdraw from the study prematurely. 3. Safety of the intervention: occurrence, type and frequency of adverse events (AEs) and serious adverse events (SAEs) associated with autonomic modulation via acupuncture 4. Recruitability: number of patients enrolled per defined recruitment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are intended to provide an exploratory assessment of potential clinical effects and to inform the planning of further studies. 1. Pain: Change in mean pain intensity (Numerical Rating Scale, NRS) from baseline to the end of the intervention. Change in maximum pain intensity during the observation period. 2. CRPS-specific disease activity: Change in the CRPS Severity Score (CSS) between baseline and follow-ups 3. Function: Change in functional limitation of the affected limb, measured using DASH (upper limb) or LEFS (lower limb). In addition, flexion and extension deficits of the respective limb are determined. 4. Autonomic and objectifiable parameters: Change in skin temperature difference between the affected and contralateral limb. Change in the degree of oedema (circumference measurement or standardised volumetry). 5. Quality of life: Change in health-related quality of life, measured using the EQ-5D-5L. 6. Analgesic requirements: Change in analgesic consumption (e.g. daily dose, morphine equivalent if applicable) over the course of the study. 7. Sustainability of potential effects: Persistence of changes in pain intensity and the CRPS Severity Score at follow-up (4 weeks after the end of treatment). 8. German Pain Questionnaire (DSF) | — |
Countries
Germany
Contacts
Public ContactErfan Ghanad
Universitätsklinikum Mannheim
Outcome results
None listed