Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

This study has been completed.
Sponsor:
Collaborator:
ANZ Trustees
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00638768
First received: March 12, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 12, 2008
March 12, 2008
February 2006
Not Provided
Back pain as assessed by a numeric rating scale [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Vertebral Fracture
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
  • Active Comparator: Physiotherapy
    Including 10 individual visits with a physiotherapist and home exercises
    Intervention: Other: Physiotherapy
  • No Intervention: 2
    Usual care
Bennell KL, Matthews B, Greig A, Briggs A, Kelly A, Sherburn M, Larsen J, Wark J. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial. BMC Musculoskelet Disord. 2010 Feb 17;11:36. doi: 10.1186/1471-2474-11-36.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
Not Provided

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00638768
010085.1
No
Professor Kim Bennell, University of Melbourne
University of Melbourne
ANZ Trustees
Principal Investigator: Kim L Bennell, PhD University of Melbourne
University of Melbourne
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP