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Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Primary Purpose

Osteoporosis, Vertebral Fracture

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring physical therapy, rehabilitation, pain, osteoporosis, vertebral fracture

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Physiotherapy, University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Physiotherapy

2

Arm Description

Including 10 individual visits with a physiotherapist and home exercises

Usual care

Outcomes

Primary Outcome Measures

Back pain as assessed by a numeric rating scale

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2008
Last Updated
March 12, 2008
Sponsor
University of Melbourne
Collaborators
ANZ Trustees
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1. Study Identification

Unique Protocol Identification Number
NCT00638768
Brief Title
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
Official Title
Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Melbourne
Collaborators
ANZ Trustees

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Vertebral Fracture
Keywords
physical therapy, rehabilitation, pain, osteoporosis, vertebral fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Including 10 individual visits with a physiotherapist and home exercises
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Back pain as assessed by a numeric rating scale
Time Frame
Baseline and 10 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim L Bennell, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physiotherapy, University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20163739
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.
Results Reference
derived

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Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

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