Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

This study has been completed.

Sponsor:

Collaborator:

ANZ Trustees

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT00638768

First received: March 12, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

March 12, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Back pain as assessed by a numeric rating scale [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis
Vertebral Fracture

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Physiotherapy
Including 10 individual visits with a physiotherapist and home exercises

Intervention: Other: Physiotherapy
No Intervention: 2
Usual care

Publications *

Bennell KL, Matthews B, Greig A, Briggs A, Kelly A, Sherburn M, Larsen J, Wark J. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial. BMC Musculoskelet Disord. 2010 Feb 17;11:36.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00638768

Other Study ID Numbers ^ICMJE

010085.1

Has Data Monitoring Committee

Responsible Party

Professor Kim Bennell, University of Melbourne

Study Sponsor ^ICMJE

University of Melbourne

Collaborators ^ICMJE

ANZ Trustees

Investigators ^ICMJE

Principal Investigator:

Kim L Bennell, PhD

University of Melbourne

Information Provided By

University of Melbourne

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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