OsteoporosisNCT03747289
Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
A study testing performing exercises in a weight bearing posture and performing exercises in a non weight bearing posture in people with Osteoporosis and Low Back Pain, run by Bait Balev Hospital at 1 site in Israel.
Trial summary
The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Low Back Pain
- What is being tested?
- performing exercises in a weight bearing posture and performing exercises in a non weight bearing posture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2018to 22 Feb 2021
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with osteoporosis (T score lower than -2.5)
- women whom had suffered from non specific low back pain for the last 3 months or more.
Who cannot join
- history of operations in the spine
- history of cancer or neurologic disease
- history of fractures
- previous trauma to the spine
- persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of a Weight Bearing Protocol and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain.
40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer.
Statistical analysis will be made in order to compare the dependent variables between groups.
Read the detailed description
40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in Bat-Yam, Israel. Each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS and lumbar range of motion measurement by a digital Inclinometer. By order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. After recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. After each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. A third identical test will be preformed two months after finishing the program.
After all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.
- Conditions
- Osteoporosis, Low Back Pain
- Being tested
- performing exercises in a weight bearing posture, performing exercises in a non weight bearing posture
- Medical subject headings
- Osteoporosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performing exercises in a weight bearing postureOther
20 participants will perform exercises in a weight bearing posture
performing exercises in a non weight bearing postureOther
20 participants will perform exercises in a non weight bearing posture
| Study group | Role | What they receive |
|---|---|---|
| weight bearing group | Experimental | performing exercises in a weight bearing posture Receives: Other: performing exercises in a weight bearing posture |
| non-weight bearing group | Active comparator | performing exercises in a non- weight bearing posture Receives: Other: performing exercises in a non weight bearing posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical disability
the Roland Morris Disability Questionnaire. The score of the questionnaire is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.
Measured: 3 months
Secondary outcomes (3)
change in lumbar range of motion - flexion and extension
digital inclinometer. The change will be assessed by the difference in number of degrees measured
Measured: 3 months
change in pain intensity
Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)
Measured: 3 months
change in health related quality of life
the Short Form-36 (SF-36) quality of life Questionnaire. A questionnaire of 36 questions, each response receives a specific value
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start20 Dec 2018
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bait Balev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747289
- Sponsor's protocol ID
- 0043-18-BBL
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of a Weight Bearing Protocol and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03747289
- Acronym / sponsor ID
- 0043-18-BBL
- Conditions
- Osteoporosis, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Bait Balev HospitalUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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 effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain.
40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer.
Statistical analysis will be made in order to compare the dependent variables between groups.
Detailed description
40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in Bat-Yam, Israel. Each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS and lumbar range of motion measurement by a digital Inclinometer. By order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. After recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. After each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. A third identical test will be preformed two months after finishing the program.
After all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight bearing group | Experimental | Other: performing exercises in a weight bearing postureperforming exercises in a weight bearing posture |
| non-weight bearing group | Active comparator | Other: performing exercises in a non weight bearing postureperforming exercises in a non- weight bearing posture |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with osteoporosis (T score lower than -2.5)
- women whom had suffered from non specific low back pain for the last 3 months or more.
Key exclusion criteria (5 listed)
- history of operations in the spine
- history of cancer or neurologic disease
- history of fractures
- previous trauma to the spine
- persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
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 |
|---|---|---|
| performing exercises in a weight bearing posture20 participants will perform exercises in a weight bearing posture | Other | weight bearing group |
| performing exercises in a non weight bearing posture20 participants will perform exercises in a non weight bearing posture | Other | non-weight bearing group |
Primary outcome
Change of physical disability
Time frame: 3 months
the Roland Morris Disability Questionnaire. The score of the questionnaire is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.
3 secondary outcomes
change in lumbar range of motion - flexion and extension
Time frame: 3 months
change in pain intensity
Time frame: 3 months
change in health related quality of life
Time frame: 3 months
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 17 Aug 2021.
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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 testing performing exercises in a weight bearing posture and performing exercises in a non weight bearing posture in people with Osteoporosis and Low Back Pain, run by Bait Balev Hospital at 1 site in Israel.
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 2 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 17 Aug 2021. 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 Israel. 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?
Change of physical disability (time frame: 3 months). 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 17 Aug 2021.