Motor Control Exercise in Osteoporotic Women

Osteoporosis Clinical Trial

Official title:

Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172574
• Other study ID #: 1112
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: July 29, 2010
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece:NKUAthens
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to explore the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.

Description:

Osteoporosis is a common metabolic bone disease that usually affects the aging population. It is an important public health problem, due to its association with vertebral and nonvertebral fractures leading to increased morbidity. Vertebral fractures are accompanied by kyphosis, reduced pulmonary function, loss of height, and are often associated with elevated pain while they may also lead to subsequent vertebral fractures. Osteoporotic individuals exhibit kyphosis in the erect standing position, which, in turn, is compensated by the deformation of other parts of the body. Improvement of postural alignment may lead to less stress on the spine, facilitate posture and proper body mechanics and may improve balance. The aim of the present study was to assess the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fracture against the results of a control group that received the basic therapies for osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Postmenopausal osteoporosis

• Osteoporotic vertebral fractures

• Pain

• Under medical osteoporotic treatment

Exclusion Criteria:

• osteoporosis other than primary postmenopausal

• vertebral collapse with neurological deficits

• more than 5 fractured vertebrae

• major respiratory conditions

• receiving pain reducing agents, teriparatide or calcitonin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal

Intervention

Other:
• Motor control exercise
Participants of the exercise group were trained to consciously co-activate the transversus abdominis, pelvic floor and thoracic erector spinae muscle, relax the lumbar multifidus and use the diaphragmatic breathing pattern. They were encouraged to activate the specific muscles of the trunk regularly during daily activities, particularly in situations where they anticipated or experienced pain such as walking, twisting, lifting low-lying objects and working with the hands in sitting or standing positions

Locations

Country	Name	City	State
Greece	Hospital Thias Pronoias 'I Pammakaristos'	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain was assessed using the visual analogue scale (VAS) of 11 numerical points (0='no pain', 10='worst imaginable pain'). Participants were asked to verbalize the presence of pain in their trunk and lower limbs during the previous 2 weeks.	Baseline	No
Primary	Pain	As described	3 months	No
Primary	Pain	As described	6 months	No
Secondary	Photographic measurements	Two-dimensional posture photography was performed using a digital Video Camera. With participants in their underwear, self-adhesive patches of 1.5 cm were placed over the left-side lateral landmarks. Women were instructed to stand in a comfortable posture with feet 20 cm apart. The participants were photographed twice at each time point. The photographs were analyzed by measuring the angles between a perpendicular line transcending the lateral malleolus, head of fibula, great trochanter, shoulder and ear. The mean of each angle of both photographs was used for statistical analysis.	Baseline	No
Secondary	Spinal curvatures	These were measured using a Sounders digital inclinometer according to the instruction manual. Standing thoracic, lumbar, and lumbosacral angle were measured. The examiner repeated the procedure three times, and if the measurements differed by more than 5 degrees, they were repeated and the second set of measurements recorded.	Baseline	No
Secondary	Photographic measurements	As described	3 months	No
Secondary	Spinal curvatures	As described	3 months	No
Secondary	Photographic measurements	As described	6 months	No
Secondary	Spinal curvatures	As described	6 month	No