Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

NCT ID: NCT00638768

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-01

Study Completion Date

2010-02-10

Brief Summary

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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

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Conditions

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Osteoporosis Vertebral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physiotherapy

Including 10 individual visits with a physiotherapist and home exercises

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

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

2

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANZ Trustees

UNKNOWN

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim L Bennell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

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School of Physiotherapy, University of Melbourne

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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. doi: 10.1186/1471-2474-11-36.

Reference Type DERIVED
PMID: 20163739 (View on PubMed)

Other Identifiers

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010085.1

Identifier Type: -

Identifier Source: org_study_id

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