Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03263585|
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : August 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Vertebral Fracture Back Pain Elderly Women||Device: Spinal orthosis Spinomed Other: Equipment training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Identification and Treatment of Back Pain in Elderly Women With Osteoporosis|
|Actual Study Start Date :||May 3, 2012|
|Actual Primary Completion Date :||November 22, 2012|
|Actual Study Completion Date :||December 22, 2014|
Active Comparator: Spinal orthosis group
Women wearing the spinal orthosis Spinomed for 6 months at least 2 hours a day.
Device: Spinal orthosis Spinomed
Active Comparator: Equipment training group
Women training once a week in an equipment training group led by a physiotherapist for six months.
Other: Equipment training
No Intervention: Control
Women in the control group get no intervention for six months.
- Back pain [ Time Frame: Baseline and six months ]Measured with Visual Analogue Scale
- Back muscle extensor strength [ Time Frame: Baseline and six months ]Measured with DigiMax in newton, women press their back against a pad for 6 seconds, three times.
- Borg CR-10 [ Time Frame: Baseline and six months ]Back pain measured by Borg CR-10
- Kyphosis [ Time Frame: Baseline and six months ]Measured by flexicurve ruler
- Substance P [ Time Frame: Baseline and six months ]Biochemical markers
- CGRP Calcitonin Gene Related Peptide [ Time Frame: Baseline and six months ]Biochemical markers
- IL-6 Interleukin [ Time Frame: Baseline and six months ]Biochemical markers
- Lung function [ Time Frame: Baseline and six months ]Spirometry
- Balance [ Time Frame: Baseline and six months ]Manual balance test
- Gait speed [ Time Frame: Baseline and six months ]Women walk 2x15 meter as fast as possible
- SF-36 [ Time Frame: Baseline and six months ]Health related quality of life
- QUALEFFO-41 [ Time Frame: Baseline and six months ]Health related quality of life
- EQ-5D [ Time Frame: Baseline and six months ]Health related quality of life
- Hand grip strength [ Time Frame: Baseline and six months ]Measured by JAMAR Manometer
- Height [ Time Frame: Baseline and six months ]Measured by stadiometer in cm
- Log book [ Time Frame: Baseline and six months ]Back pain measured by log book
- Paindrawing [ Time Frame: Baseline and six months ]Back pain measured by paindrawing
- Falls [ Time Frame: Baseline and six months ]Self reported falls
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263585
|Stockholm, Sweden, 11361|
|Liljeholmen Academic Health Centre|
|Stockholm, Sweden, 11763|
|Principal Investigator:||Eeva Helena S Salminen, MD, PhD||Karolinska Institutet|