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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00638768




Registration number
NCT00638768
Ethics application status
Date submitted
12/03/2008
Date registered
19/03/2008
Date last updated
19/03/2008

Titles & IDs
Public title
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
Scientific title
Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
Secondary ID [1] 0 0
010085.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Vertebral Fracture 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Physiotherapy

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

No Intervention: 2 - Usual care


Other interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Back pain as assessed by a numeric rating scale
Timepoint [1] 0 0
Baseline and 10 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and 10 weeks

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
School of Physiotherapy, University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ANZ Trustees
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00638768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim L Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00638768