fibromatosis plantaris fascialis Ledderhose
Conditions
Interventions
Radiotherapy:
After consultation of a plastic surgeon (who will confirm that the patient has
Ledderhose disease), patients will be referred to the radiotherapy department.
The patient will be first
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain). • Age >= 18 years • WHO performance status 0, 1 or 2 • Before patient randomisation, written informed consent must be given according to ICH/GCP, and local regulations • Able and willing to complete quality of life questionnaires in English or Dutch • Must be accessible for treatment follow-up
Exclusion criteria
Exclusion criteria: • Surgical intervention before for Ledderhose disease • Previous radiation treatment for Ledderhose disease • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule • Not able to lay prone for at least fifteen minutes • Females who are pregnant at entry or who want to become pregnant within six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) score at 12 months: The most important complaint of a patient with Ledderhose disease is pain, generally irrespective of the size of the nodules. Therefore, the primary endpoint will be pain relief at 12 months after treatment, measured by the Numeric Rating Scale. This 11-point-scale is used to assess the worst pain experienced by the patient in the previous week with scale endpoints from 0 (no pain) to 10 (worst imaginable pain) points. The pain response (complete or partial) is defined as a decrease of the initial NRS-score by at least two points. Complete response is a NRS-score of 0 points. A partial response is defined as a remaining NRS-score of at least 1 point. Stable disease is defined as one or zero NRS-score point change in either direction from the initial NRS-score. Progressive disease is defined as an increase in the initial NRS-score of at least two points. Time to response and time to progression are calculated from the date of randomisation until the date of response and date of progression, respectively. * A complete response (CR): NRS-score = 0. * A partial response (PR): NRS-score = 1 and/or at least 2 points decrease from initial NRS-score * A stable disease (SD): 1-point NRS-score change from initial NRS-score in either direction. * A progressive disease (PD): Increase in at least 2 NRS-score points from the initial NRS-score. | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS-score at 6 and 18 months: The NRS-score at 6 and 18 months will be scored the same way as NRS-score at 12 months. Size of Ledderhose nodules at 12 months: The size of the Ledderhose nodules will be measured using MRI and ultrasound at 12 months and compared with MRI and ultrasound at baseline. 10 meter straight line walk test Patients will be asked at different time points to walk in a straight line for 10 meters at their usual (self-selected) speed and their maximum walking speed. The VAS-score will be assessed before and after walking. Time points are baseline, 6, 12 and 18 months. PEDAR (UMCG only) Pedobarography is a technique which can measure dynamic plantar foot pressure during walking. Time points are baseline and 12 months. Pain medication The amount of pain medication will be scored at different time points. Time points are baseline, 6, 12 and 18 months. The amount of pain medication consumed in the week before each time point will be scored. Questionnaires: The RAND-36 and the brief pain inventory are questionnaires that will be filled in at different time points. Time points are baseline, 6, 12 and 18 months, and from 2 years annually until the end of follow-up. * The RAND-36 item Health Survey (RAND-36): This is a short version of the RAND Health Insurance Study Questionnaire and is almost identical to the Medical Outcome Study (MOS) Short-Form-36 (SF-36). These questionnaires are used to measure patient health. * The brief pain inventory: This tool measures both the intensity of pain and the interference of pain in the patient*s life. * The EURO-QoL-5D: This is a standardised instrument to measure generic health status. | — |
Countries
Netherlands
Outcome results
None listed