NCT00638768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2010

Completed
Last Updated

July 10, 2025

Status Verified

March 1, 2008

Enrollment Period

3.9 years

First QC Date

March 12, 2008

Last Update Submit

July 7, 2025

Conditions

OsteoporosisVertebral Fracture

Keywords

physical therapyrehabilitationpainosteoporosisvertebral fracture

Outcome Measures

Primary Outcomes (1)

  • Back pain as assessed by a numeric rating scale

    Baseline and 10 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR

Including 10 individual visits with a physiotherapist and home exercises

Other: Physiotherapy

2

NO INTERVENTION

Usual care

Interventions

PhysiotherapyOTHER

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

Physiotherapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physiotherapy, University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (1)

  • 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.

    PMID: 20163739DERIVED

MeSH Terms

Conditions

OsteoporosisSpinal FracturesPain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Kim L Bennell, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

February 1, 2006

Primary Completion

January 1, 2010

Study Completion

February 10, 2010

Last Updated

July 10, 2025

Record last verified: 2008-03

Locations

AU(1)