Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

July 7, 2025 updated by: University of Melbourne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • School of Physiotherapy, University of Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Usual care
Active Comparator: Physiotherapy
Including 10 individual visits with a physiotherapist and home exercises
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

ANZ Trustees

Investigators

  • Principal Investigator: Kim L Bennell, PhD, University of Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 10, 2010

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimated)

March 19, 2008

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010085.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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