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Completed

NCT Number: NCT03747289

Comparison of a Weight Bearing 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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi health services

Bat Yam, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

performing exercises in a weight bearing posture

Other

20 participants will perform exercises in a weight bearing posture

performing exercises in a non weight bearing posture

Other

20 participants will perform exercises in a non weight bearing posture

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bait Balev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2018
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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