Osteoporosis Clinical Trial
Official title:
Identification and Treatment of Back Pain in Elderly Women With Osteoporosis
Verified date | August 2017 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | December 22, 2014 |
Est. primary completion date | November 22, 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria - Woman aged = 60 years - Osteoporosis according to DXA (Dual X-Ray Absorptiometry) hip (femoral neck or total hip) or lumbar spine. - Back pain. Exclusion Criteria - Diagnosed symptomatic spinal stenosis - Difficulty to participate in the activities included in the study due to health problems. - Difficulty to participate in equipment training group. - Inability to be able to complete wearing the spinal orthosis. - Language difficulties - Cognitive difficulties - Visual problems |
Country | Name | City | State |
---|---|---|---|
Sweden | Liljeholmen Academic Health Centre | Stockholm | |
Sweden | Rehab City | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Helena Salminen | Medi GmbH & Co.KG |
Sweden,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Back pain | Measured with Visual Analogue Scale | Baseline and six months | |
Secondary | Back muscle extensor strength | Measured with DigiMax in newton, women press their back against a pad for 6 seconds, three times. | Baseline and six months | |
Secondary | Borg CR-10 | Back pain measured by Borg CR-10 | Baseline and six months | |
Secondary | Kyphosis | Measured by flexicurve ruler | Baseline and six months | |
Secondary | Substance P | Biochemical markers | Baseline and six months | |
Secondary | CGRP Calcitonin Gene Related Peptide | Biochemical markers | Baseline and six months | |
Secondary | IL-6 Interleukin | Biochemical markers | Baseline and six months | |
Secondary | Lung function | Spirometry | Baseline and six months | |
Secondary | Balance | Manual balance test | Baseline and six months | |
Secondary | Gait speed | Women walk 2x15 meter as fast as possible | Baseline and six months | |
Secondary | SF-36 | Health related quality of life | Baseline and six months | |
Secondary | QUALEFFO-41 | Health related quality of life | Baseline and six months | |
Secondary | EQ-5D | Health related quality of life | Baseline and six months | |
Secondary | Hand grip strength | Measured by JAMAR Manometer | Baseline and six months | |
Secondary | Height | Measured by stadiometer in cm | Baseline and six months | |
Secondary | Log book | Back pain measured by log book | Baseline and six months | |
Secondary | Paindrawing | Back pain measured by paindrawing | Baseline and six months | |
Secondary | Falls | Self reported falls | Baseline and six months |
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