Back to resultsComparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
Primary Purpose
Osteoporosis, Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
performing exercises in a weight bearing posture
performing exercises in a non weight bearing posture
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Maccabi health services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
weight bearing group
non-weight bearing group
Arm Description
performing exercises in a weight bearing posture
performing exercises in a non- weight bearing posture
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change in lumbar range of motion - flexion and extension
digital inclinometer. The change will be assessed by the difference in number of degrees measured
change in pain intensity
Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03747289
Brief Title
Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bait Balev Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
the investigator will check all the participants without knowing to which group they are assigned to
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weight bearing group
Arm Type
Experimental
Arm Description
performing exercises in a weight bearing posture
Arm Title
non-weight bearing group
Arm Type
Active Comparator
Arm Description
performing exercises in a non- weight bearing posture
Intervention Type
Other
Intervention Name(s)
performing exercises in a weight bearing posture
Intervention Description
20 participants will perform exercises in a weight bearing posture
Intervention Type
Other
Intervention Name(s)
performing exercises in a non weight bearing posture
Intervention Description
20 participants will perform exercises in a non weight bearing posture
Primary Outcome Measure Information:
Title
Change of physical disability
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in lumbar range of motion - flexion and extension
Description
digital inclinometer. The change will be assessed by the difference in number of degrees measured
Time Frame
3 months
Title
change in pain intensity
Description
Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)
Time Frame
3 months
Title
change in health related quality of life
Description
the Short Form-36 (SF-36) quality of life Questionnaire. A questionnaire of 36 questions, each response receives a specific value
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Maccabi health services
City
Bat Yam
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
We'll reach out to this number within 24 hrs