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

Comparison of the Effect of a Weight Bearing Protocol 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Osteoporosis
• Intervention / Treatment: Other: performing exercises in a weight bearing posture; Other: performing exercises in a non weight bearing posture

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bat Yam, Israel
    • Maccabi Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in pain intensity	Visual Analogue Scale (VAS). A scale from 0 (no pain) to 10 (the worst possible pain)	3 months
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

Collaborators and Investigators

• Sponsor: Bait Balev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): February 22, 2021

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Back Pain; Low Back Pain; Osteoporosis
• Other Study ID Numbers: 0043-18-BBL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No