Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Overview

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.

Full Title of Study: “Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Physiotherapy
    • Including 10 individual visits with a physiotherapist and home exercises
  • No Intervention: 2
    • Usual care

Clinical Trial Outcome Measures

Primary Measures

  • Back pain as assessed by a numeric rating scale
    • Time Frame: Baseline and 10 weeks

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Melbourne
  • Collaborator
    • ANZ Trustees
  • Provider of Information About this Clinical Study
    • Professor Kim Bennell, University of Melbourne
  • Overall Official(s)
    • Kim L Bennell, PhD, Principal Investigator, University of Melbourne

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