Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Identification and Treatment of Back Pain in Elderly Women With Osteoporosis
Brief Summary: Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain.

Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life.

The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial).

Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.


Options:
A: Arm Label: Physiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Physiotherapy | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Physiotherapy; Assigned to Arm(s): Physiotherapy
B: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Intervention
C: Arm Label: Spinal orthosis group; Type: ACTIVE_COMPARATOR; Interventions: Device: Spinal orthosis Spinomed | Arm Label: Equipment training group; Type: ACTIVE_COMPARATOR; Interventions: Other: Equipment training | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Spinal orthosis Spinomed; Assigned to Arm(s): Spinal orthosis group | Intervention Type: OTHER; Name: Equipment training; Assigned to Arm(s): Equipment training group
D: Arm Label: Physical Activity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physical Activity | Arm Label: Successful Aging; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Successful Aging | Intervention Type: BEHAVIORAL; Name: Physical Activity; Assigned to Arm(s): Physical Activity | Intervention Type: BEHAVIORAL; Name: Successful Aging; Assigned to Arm(s): Successful Aging

Answer: C