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Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

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: NCT00638768
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : March 19, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.

Condition or disease Intervention/treatment Phase
Osteoporosis Vertebral Fracture Other: Physiotherapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Physiotherapy
Including 10 individual visits with a physiotherapist and home exercises
Other: Physiotherapy
10 weekly individual sessions with the therapist each lasting approximately 45 minutes. Techniques included postural taping, massage, mobilisation, exercises. The patients also performed home exercises
No Intervention: 2
Usual care


Outcome Measures

Primary Outcome Measures :
  1. Back pain as assessed by a numeric rating scale [ Time Frame: Baseline and 10 weeks ]

Secondary Outcome Measures :
  1. activity restriction, health-related quality of life and physical activity levels as well as overall perceived rating of change in back pain. Objective measures of thoracic kyphosis, standing balance, back and shoulder muscle endurance [ Time Frame: Baseline and 10 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • if female, at least five years post-menopause
  • aged > 50 years
  • primary osteoporosis defined as DXA T score < -2.5 at either the spine or proximal femur with at least one morphometric vertebral crush fracture sustained between 3 months to 2 years previously
  • back pain/discomfort in thoracic or lumbar region felt at least weekly within the last 6 months
  • stable dose of medication for treatment of osteoporosis (eg. hormone replacement therapy, bisphosphonates)
  • community dwelling and able to attend for treatment
  • English speaking

Exclusion Criteria:

  • secondary causes of bone loss such as osteomalacia, glucocorticoid medication etc.
  • co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
  • acute vertebral fracture in past 3 months
  • signs and symptoms arising from nerve root compression
  • back pain radiating into the lower limb
  • previous participation in a formal pain management program for back pain
  • physiotherapy for back pain in the past 6 months
  • allergic reaction to adhesive tape or poor skin condition that would prevent use of tape
Contacts and Locations

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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): NCT00638768


Locations
Australia, Victoria
School of Physiotherapy, University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
University of Melbourne
ANZ Trustees
Investigators
Principal Investigator: Kim L Bennell, PhD University of Melbourne
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier: NCT00638768     History of Changes
Other Study ID Numbers: 010085.1
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: March 2008

Keywords provided by University of Melbourne:
physical therapy
rehabilitation
pain
osteoporosis
vertebral fracture

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Spinal Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries