OsteoporosisNCT01172574
Motor Control Exercise in Osteoporotic Women
A study of Osteoporosis and Postmenopausal, run by National and Kapodistrian University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal osteoporosis
- Osteoporotic vertebral fractures
- Pain
- Under medical osteoporotic treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Motor control exercise
- Keywords
- Osteoporosis, Pain, Kyphosis, Posture, Exercise therapy
- Medical subject headings
- Osteoporosis, Pain, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor control exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Motor control exercise | Experimental | 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. Receives: Other: Motor control exercise |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Pain
As described
Measured: 3 months
Pain
As described
Measured: 6 months
Secondary outcomes (6)
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.
Measured: Baseline
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.
Measured: Baseline
Photographic measurements
As described
Measured: 3 months
Spinal curvatures
As described
Measured: 3 months
Photographic measurements
As described
Measured: 6 months
Spinal curvatures
As described
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startNov 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172574
- Sponsor's protocol ID
- 1112
- Status last verified
- Jan 2008
- First submitted
- 28 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01172574
- Acronym / sponsor ID
- 1112
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Osteoporosis, Pain, Kyphosis, Posture, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor control exercise | Experimental | Other: Motor control exerciseSubjects 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal osteoporosis
- Osteoporotic vertebral fractures
- Pain
- Under medical osteoporotic treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor control exerciseParticipants 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 | Other | Motor control exercise |
Primary outcome
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.
Pain
Time frame: 3 months
As described
Pain
Time frame: 6 months
As described
6 secondary outcomes
Photographic measurements
Time frame: Baseline
Spinal curvatures
Time frame: Baseline
Photographic measurements
Time frame: 3 months
Spinal curvatures
Time frame: 3 months
Photographic measurements
Time frame: 6 months
Spinal curvatures
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Osteoporosis and Postmenopausal, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2010.