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Completed

NCT Number: NCT00638768

Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

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.

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Key information

Conditions

Osteoporosis Back Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Fractures Spinal Injuries Vertebral Fracture Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Physiotherapy, University of Melbourne

Melbourne, Victoria, 3010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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

Primary outcomes

  1. Back pain as assessed by a numeric rating scale

    Time frame: Baseline and 10 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • ANZ Trustees

Registry information

Official study title

Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2008
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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