Motor Control Exercise in Osteoporotic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172574
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : July 30, 2010
Information provided by:
National and Kapodistrian University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Postmenopausal Other: Motor control exercise Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial
Study Start Date : November 2006
Actual Study Completion Date : January 2008

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U.S. FDA Resources

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.
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
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.

Primary Outcome Measures :
  1. Pain [ Time Frame: Baseline ]
    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.

  2. Pain [ Time Frame: 3 months ]
    As described

  3. Pain [ Time Frame: 6 months ]
    As described

Secondary Outcome Measures :
  1. Photographic measurements [ Time Frame: Baseline ]
    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.

  2. 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.

  3. Photographic measurements [ Time Frame: 3 months ]
    As described

  4. Spinal curvatures [ Time Frame: 3 months ]
    As described

  5. Photographic measurements [ Time Frame: 6 months ]
    As described

  6. Spinal curvatures [ Time Frame: 6 month ]
    As described

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01172574

Hospital Thias Pronoias 'I Pammakaristos'
Athens, Attica, Greece, 11144
Sponsors and Collaborators
National and Kapodistrian University of Athens

Responsible Party: Dr. Palina Karakasidou, Researcher, Laboratory for Research of the Musculoskeletal System, School of Medicine Identifier: NCT01172574     History of Changes
Other Study ID Numbers: 1112
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: January 2008

Keywords provided by National and Kapodistrian University of Athens:
Exercise therapy

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases