Clinical trial NCT00638768: Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
Official title: Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Vertebral Fracture
Keywords: physical therapy
rehabilitation
pain
osteoporosis
vertebral fracture
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: ANZ Trustees
First posted: 2008-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Back pain as assessed by a numeric rating scale
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: School of Physiotherapy, University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kim L Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.