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Motor Control Exercise in Osteoporotic Women

This study has been completed.
Sponsor:
Information provided by:
National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01172574
First received: July 28, 2010
Last updated: July 29, 2010
Last verified: January 2008
  Purpose

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 Intervention
Osteoporosis
Postmenopausal
Other: Motor control exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • Pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As described

  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As described


Secondary Outcome Measures:
  • Photographic measurements [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Spinal curvatures [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Photographic measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As described

  • Spinal curvatures [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As described

  • Photographic measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As described

  • Spinal curvatures [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    As described


Enrollment: 20
Study Start Date: November 2006
Study Completion Date: January 2008
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172574

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

No publications provided

Responsible Party: Dr. Palina Karakasidou, Researcher, Laboratory for Research of the Musculoskeletal System, School of Medicine
ClinicalTrials.gov Identifier: NCT01172574     History of Changes
Other Study ID Numbers: 1112
Study First Received: July 28, 2010
Last Updated: July 29, 2010
Health Authority: Greece:NKUAthens

Keywords provided by National and Kapodistrian University of Athens:
Osteoporosis
Pain
Kyphosis
Posture
Exercise therapy

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

ClinicalTrials.gov processed this record on November 20, 2014