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Completed

NCT Number: NCT01172574

Motor Control Exercise in Osteoporotic Women

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Kyphosis Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Postmenopausal Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Thias Pronoias 'I Pammakaristos'

Athens, Attica, 11144, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor control exercise

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Jul 30, 2010
Registry last updated
Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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