Vertebral Bony Metastases Clinical Trial
Official title:
Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy
Standard indications for palliative radiation of bony metastases include pain, spinal cord
compression, and impending pathologic fractures.
Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid
complications. Tailored training of the paravertebral musculature may support Radiation
therapy and improve above named factors. DISPO-2 was designed to investigate the impact of
tailored physical exercise in patients with unstable vertebral metastases as compared to
manual therapy (massage etc.). The trial includes patients with painful unstable bony
metastases, patients with spinal cord compression or impending pathological fractures are
excluded. The investigations are carried out in a prospective randomized controlled phase-II
parallel group design.
Standard indications for palliative radiation of bony metastases include pain, spinal cord
compression, and impending pathologic fractures. Palliative radiation therapy serves to
reduce pain, improve quality of life, and avoid complications. Tailored training of the
paravertebral musculature may support radiation therapy and improve above named factors.
DISPO-2 was designed to investigate the impact of tailored physical exercise in patients
with unstable vertebral metastases as compared to manual therapy (progressive muscle
relaxation). The trial includes patients with painful bony metastases, patients with spinal
cord compression or impending pathological fractures are excluded. The investigations are
carried out in a prospective randomized controlled phase-II parallel group design.
Patients are randomized to one of the following groups: patients in arm A carry out daily
physical training consisting of four different isometric exercises under the guidance and
supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10
daily units of 30 min each are scheduled during radiotherapy. Patients are expected to
continue training until 12 weeks post completion of radiotherapy at home. Patients in arm B
(control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting
from day one of radiotherapy. Follow-up of the patients is scheduled at 12 weeks post
completion of radiotherapy incl. CT of the spine and physical examination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Phase 2 | |
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