Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT03747289|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : July 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Low Back Pain||Other: performing exercises in a weight bearing posture Other: performing exercises in a non weight bearing posture||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||the investigator will check all the participants without knowing to which group they are assigned to|
|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|
|Actual Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||June 15, 2021|
|Estimated Study Completion Date :||September 15, 2021|
Experimental: weight bearing group
performing exercises in a weight bearing posture
Other: performing exercises in a weight bearing posture
20 participants will perform exercises in a weight bearing posture
Active Comparator: non-weight bearing group
performing exercises in a non- weight bearing posture
Other: performing exercises in a non weight bearing posture
20 participants will perform exercises in a non weight bearing posture
- 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.
- change in lumbar range of motion - flexion and extension [ Time Frame: 3 months ]digital inclinometer. The change will be assessed by the difference in number of degrees measured
- change in pain intensity [ Time Frame: 3 months ]Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)
- change in health related quality of life [ Time Frame: 3 months ]the Short Form-36 (SF-36) quality of life Questionnaire. A questionnaire of 36 questions, each response receives a specific value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747289
|Contact: Adi Talmor, Bptfirstname.lastname@example.org|
|Contact: Youssef Masharawi, Dremail@example.com|
|Maccabi health services||Recruiting|
|Bat Yam, Israel|
|Contact: Guy Rotem, Bpt 972549988320 firstname.lastname@example.org|
|Contact: Shirly Cohen-hevroni 972523651195 Cohenhev_s@mac.org.il|
|Sub-Investigator: Adi Talmor, Bpt|
|Principal Investigator: Vered Eliyahu, Dr|
|Sub-Investigator: Yosseff Masharawi, Dr|
|Sub-Investigator: Masha Elias-Sosner, Mpt|