- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172574
Motor Control Exercise in Osteoporotic Women
July 29, 2010 updated by: National and Kapodistrian University of Athens
Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Attica
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Athens, Attica, Greece, 11144
- Hospital Thias Pronoias 'I Pammakaristos'
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motor control exercise
Subjects of the exercise group underwent a 3-month (13-week) treatment program directed on 3-weekly 1-hr one-to-one sessions by the researcher who had experience in the specific exercise treatment of the spinal region.
During the next 3 months, the subjects were urged to perform the exercises alone at home at least once a day, and compliance was monitored by the activity quota chart given to them at the beginning of each study-month.
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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
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No Intervention: Control group
The control group underwent treatment throughout a 6-month period, directed by each patient's medical practitioner.
This consisted of the patients carrying out regular weekly general exercises (walking and swimming).
Three of them regularly attended other treatment providers involving group general exercise programs.
Two patients received the application of local pain-relieving methods such as heat, massage, laser and ultrasound and one did nothing except for receiving osteoporotic medication.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: Baseline
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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.
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Baseline
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Pain
Time Frame: 3 months
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As described
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3 months
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Pain
Time Frame: 6 months
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As described
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photographic measurements
Time Frame: Baseline
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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.
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Baseline
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Spinal curvatures
Time Frame: Baseline
|
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.
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Baseline
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Photographic measurements
Time Frame: 3 months
|
As described
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3 months
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Spinal curvatures
Time Frame: 3 months
|
As described
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3 months
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Photographic measurements
Time Frame: 6 months
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As described
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6 months
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Spinal curvatures
Time Frame: 6 month
|
As described
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6 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
July 29, 2010
First Posted (Estimate)
July 30, 2010
Study Record Updates
Last Update Posted (Estimate)
July 30, 2010
Last Update Submitted That Met QC Criteria
July 29, 2010
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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