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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 : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bait Balev Hospital

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.


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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: the investigator will check all the participants without knowing to which group they are assigned to
Primary Purpose: Treatment
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, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. change in pain intensity [ Time Frame: 3 months ]
    Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Adi Talmor, Bpt 972-50-8463333 talmor_a@mac.org.il
Contact: Youssef Masharawi, Dr 972-50-7288737 yossefm@post.tau.ac.il

Locations
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Israel
Maccabi health services Recruiting
Bat Yam, Israel
Contact: Guy Rotem, Bpt    972549988320    rotem_g@mac.org.il   
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         
Sponsors and Collaborators
Bait Balev Hospital

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Responsible Party: Bait Balev Hospital
ClinicalTrials.gov Identifier: NCT03747289     History of Changes
Other Study ID Numbers: 0043-18-BBL
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Osteoporosis
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases