Vertebral Bony Metastases Clinical Trial
Official title:
Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy
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 was designed to investigate the impact of
tailored physical exercise in patients with vertebral metastases as compared to manual
therapy (massage etc.). 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.
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 was designed to investigate the impact of
tailored physical exercise in patients with vertebral metastases as compared to manual
therapy (massage etc.). 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 three 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 manual therapy (i.e.
massage, etc) 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
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