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

University of Melbourne1 site in 1 country20 target enrollmentFebruary 1, 2006

ConditionsOsteoporosis Vertebral Fracture

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Osteoporosis
Sponsor: University of Melbourne
Enrollment: 20
Locations: 1
Primary Endpoint: Back pain as assessed by a numeric rating scale
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2006

End Date

February 10, 2010

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Melbourne

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Back pain as assessed by a numeric rating scale

Time Frame: Baseline and 10 weeks

Secondary Outcomes

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)