Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Phase 2

Completed

• Conditions: Osteoporosis; Vertebral Fracture
• Interventions: Other: Physiotherapy

• Registration Number: NCT00638768
• Lead Sponsor: University of Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Last Update Submitted: 2008-03-12
• Study First Posted: 2008-03-19
• Last Update Posted: 2008-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	Including 10 individual visits with a physiotherapist and home exercises

Primary Outcome Measures

Name	Time	Method
Back pain as assessed by a numeric rating scale	Baseline and 10 weeks

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 10 weeks

Trial Locations

Locations (1)

School of Physiotherapy, University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia