OsteoporosisPhase 2NCT00638768
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
A Phase 2 study testing Physiotherapy in people with Osteoporosis and Vertebral Fracture, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2006to 10 Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Physiotherapy, University of Melbourne
Melbourne, Victoria, 3010
About this study
Official title: 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.
- Conditions
- Osteoporosis, Vertebral Fracture
- Being tested
- Physiotherapy
- Keywords
- physical therapy, rehabilitation, pain, osteoporosis, vertebral fracture
- Medical subject headings
- Osteoporosis, Spinal Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Including 10 individual visits with a physiotherapist and home exercises Receives: Other: Physiotherapy |
| 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain as assessed by a numeric rating scale
Measured: 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
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study start1 Feb 2006
- Primary completion1 Jan 2010
- Study completion10 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- ANZ Trustees
- Responsible party
- Sponsor
- Investigators
- Kim L Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638768
- Sponsor's protocol ID
- 010085.1
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1186/1471-2474-11-36.
PubMed 20163739
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT00638768
- Acronym / sponsor ID
- 010085.1
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- physical therapy, rehabilitation, pain, osteoporosis, vertebral fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- ANZ Trustees
- Study start
- 1 Feb 2006 (actual)
- Primary completion
- 1 Jan 2010 (actual)
- Study completion
- 10 Feb 2010 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Other: PhysiotherapyIncluding 10 individual visits with a physiotherapist and home exercises |
| 2 | No intervention | –Usual care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy10 weekly individual sessions with the therapist each lasting approximately 45 minutes. Techniques included postural taping, massage, mobilisation, exercises. The patients also performed home exercises | Other | Physiotherapy |
Primary outcome
Back pain as assessed by a numeric rating scale
Time frame: Baseline and 10 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 20163739Bennell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim L Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physiotherapy in people with Osteoporosis and Vertebral Fracture, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain as assessed by a numeric rating scale (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.