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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747289
• Other study ID #: 0043-18-BBL
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: February 22, 2021

Study information

• Verified date: January 2021
• Source: Bait Balev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Osteoporosis

Intervention

Other:
• performing exercises in a weight bearing posture
20 participants will perform exercises in a weight bearing posture
• performing exercises in a non weight bearing posture
20 participants will perform exercises in a non weight bearing posture

Locations

Country	Name	City	State
Israel	Maccabi health services	Bat Yam

Sponsors (1)

Lead Sponsor	Collaborator
Bait Balev Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	change in lumbar range of motion - flexion and extension	digital inclinometer. The change will be assessed by the difference in number of degrees measured	3 months
Secondary	change in pain intensity	Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)	3 months
Secondary	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	3 months