M25 M19
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chronic wrist pain due to traumatic causes for at least three months
Exclusion criteria
Exclusion criteria: Peripheral nerve diseases, fibromyalgia, complex regional pain syndrome, language barrier, no written consent, refusal of follow-up examinations, ongoing immunosuppressive or antineoplastic therapy, severe cognitive limitations (advanced dementia, acute psychoses, traumatic brain injuries), acute suicidality, surgical treatment of the affected wrist during the intervention period and the subsequent 12-month examination period, contraindications to Scandicain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary target is pain reduction. The target is assessed pre-intervention, after the fifth and tenth infiltration, and at three post-intervention time points (3, 6, and 12 months). Various assessment methods are planned to capture the primary target "pain": •Pain localization: Differentiation between radio-, medio-, and ulnocarpal locations is determined palpatorily by the examiner. •NRS (Numeric Rating Scale): Patients are asked to rate their subjective pain on a scale from 0-100, where "0" represents "no pain" and "100" represents the "worst imaginable pain." •Pain detect: This is a pain questionnaire allowing differentiated information on pain intensity, location, type, and course. The results help estimate the extent to which the pain is based on a neuropathic component. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to pain assessment, further target parameters are collected, along with the primary endpoint (see above). The secondary target parameters focus on hand function and involve the following examination methods: • Wrist Mobility: The range of motion of the wrist is determined on both sides using the Neutral-Zero method with an angle measurer. The three degrees of freedom of the wrist are measured: supination/pronation, flexion/extension, ulnar/radial deviation. • Strength Measurement using Jamar Dynamometer: The gross strength of the affected hand is determined with a Jamar Dynamometer (Sammons Preston Inc., Bolingbrook, IL, USA) and compared with the opposite side. • Two-Point Discrimination: Using a two-point discriminator, the test starts with a 4mm spacing (normal range). The instrument is aligned along the longitudinal axis of the fingers and placed on the finger without applying additional pressure. The instrument remains for five seconds, and the patient indicates whether they felt one or two points. If the patient cannot discern a two-point touch, the next larger spacing on the test device is chosen. The distance at which the patient can discriminate between two touch points is documented. • Pinch Gauge Test: Finger strength is measured using a precision grip strength gauge (key grip, two-point grip, and three-point grip). • Sharp-Dull Discrimination: The skin on the hand is touched in the corresponding area (N1-N10) with a sharp and a dull object (e.g., the sharp and dull ends of a paperclip). The patient is asked to distinguish between sharp and dull and assign them. The test is repeated three times per area. • Cold-Hot Discrimination: Test tubes filled with cold and hot water are used for this test. The skin areas to be examined (N1-N10) are alternately touched with the hot and cold objects. The test is repeated three times per area, and the patient's assignment is noted. Additionally, hand-specific data are collected through: • Ma | — |
Countries
Germany
Contacts
Ludwig-Guttmann-Str. 13