Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Osteoporosis Clinical Trial

Official title:

Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638768
• Other study ID #: 010085.1
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: March 12, 2008
• Start date: February 2006

Study information

• Verified date: March 2008
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Spinal Fractures
• Vertebral Fracture

Intervention

Other:
• 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

Locations

Country	Name	City	State
Australia	School of Physiotherapy, University of Melbourne	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	ANZ Trustees

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back pain as assessed by a numeric rating scale		Baseline and 10 weeks	No
Secondary	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	No