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Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group

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ClinicalTrials.gov Identifier: NCT03263585
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Medi GmbH & Co.KG
Information provided by (Responsible Party):
Helena Salminen, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Osteoporosis Vertebral Fracture Back Pain Elderly Women Device: Spinal orthosis Spinomed Other: Equipment training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Back pain [ Time Frame: Baseline and six months ]
    Measured with Visual Analogue Scale


Secondary Outcome Measures :
  1. 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.

  2. Borg CR-10 [ Time Frame: Baseline and six months ]
    Back pain measured by Borg CR-10

  3. Kyphosis [ Time Frame: Baseline and six months ]
    Measured by flexicurve ruler

  4. Substance P [ Time Frame: Baseline and six months ]
    Biochemical markers

  5. CGRP Calcitonin Gene Related Peptide [ Time Frame: Baseline and six months ]
    Biochemical markers

  6. IL-6 Interleukin [ Time Frame: Baseline and six months ]
    Biochemical markers

  7. Lung function [ Time Frame: Baseline and six months ]
    Spirometry

  8. Balance [ Time Frame: Baseline and six months ]
    Manual balance test

  9. Gait speed [ Time Frame: Baseline and six months ]
    Women walk 2x15 meter as fast as possible

  10. SF-36 [ Time Frame: Baseline and six months ]
    Health related quality of life

  11. QUALEFFO-41 [ Time Frame: Baseline and six months ]
    Health related quality of life

  12. EQ-5D [ Time Frame: Baseline and six months ]
    Health related quality of life

  13. Hand grip strength [ Time Frame: Baseline and six months ]
    Measured by JAMAR Manometer

  14. Height [ Time Frame: Baseline and six months ]
    Measured by stadiometer in cm

  15. Log book [ Time Frame: Baseline and six months ]
    Back pain measured by log book

  16. Paindrawing [ Time Frame: Baseline and six months ]
    Back pain measured by paindrawing

  17. Falls [ Time Frame: Baseline and six months ]
    Self reported falls



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sweden
Rehab City
Stockholm, Sweden, 11361
Liljeholmen Academic Health Centre
Stockholm, Sweden, 11763
Sponsors and Collaborators
Helena Salminen
Medi GmbH & Co.KG
Investigators
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Principal Investigator: Eeva Helena S Salminen, MD, PhD Karolinska Institutet
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helena Salminen, PI, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03263585    
Other Study ID Numbers: dnr 2011/142-31/3
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is available only for the research group and available for other researchers only after new ethical review and in collaboration

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena Salminen, Karolinska Institutet:
Osteoporosis
Vertebral Fracture
Back Pain
Spinal orthosis
Elderly women
Additional relevant MeSH terms:
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Osteoporosis
Back Pain
Spinal Fractures
Fractures, Bone
Wounds and Injuries
Pain
Neurologic Manifestations
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries