Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain

NCT ID: NCT03747289

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2021-02-22

Brief Summary

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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

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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

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Osteoporosis Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
the investigator will check all the participants without knowing to which group they are assigned to

Study Groups

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weight bearing group

performing exercises in a weight bearing posture

Group Type EXPERIMENTAL

performing exercises in a weight bearing posture

Intervention Type OTHER

20 participants will perform exercises in a weight bearing posture

non-weight bearing group

performing exercises in a non- weight bearing posture

Group Type ACTIVE_COMPARATOR

performing exercises in a non weight bearing posture

Intervention Type OTHER

20 participants will perform exercises in a non weight bearing posture

Interventions

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performing exercises in a weight bearing posture

20 participants will perform exercises in a weight bearing posture

Intervention Type OTHER

performing exercises in a non weight bearing posture

20 participants will perform exercises in a non weight bearing posture

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bait Balev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maccabi health services

Bat Yam, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0043-18-BBL

Identifier Type: -

Identifier Source: org_study_id

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