Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture - Full Text View

Sponsor:	University of Melbourne
Collaborator:	ANZ Trustees
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00638768

Purpose

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	Intervention	Phase
Osteoporosis Vertebral Fracture	Other: Physiotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:

Back pain as assessed by a numeric rating scale [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	February 2006

Arms	Assigned Interventions
Physiotherapy: Active Comparator 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
2: No Intervention Usual care

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	University of Melbourne ( Professor Kim Bennell )
Study ID Numbers:	010085.1
Study First Received:	March 12, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00638768 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by University of Melbourne:

physical therapy
rehabilitation
pain
osteoporosis
vertebral fracture

Additional relevant MeSH terms:

Musculoskeletal Diseases
Spinal Injuries
Fractures, Bone
Back Injuries
Wounds and Injuries

Spinal Fractures
Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on November 25, 2009