Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

Low Back Pain, Recurrent Clinical Trial

Official title:

Patient Preference Effect on Adherence and Efficacy of Exercise for Non-specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984864
• Other study ID #: AU-HEA-SS-20190522
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: Ariel University
• Contact: shmuel springer
• Phone: +97239066330
• Email: shmuels[@]ariel.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Low back pain, mainly nonspecific (NSLBP) is a major cause of pain and disability worldwide. Exercise therapy (ET) is considered as the first line treatment, and it is one of the treatment modalities most commonly used by physiotherapists. Yet, ET is reliant on the adherence of patients to its various components. Research has demonstrated a positive relationship between adherence to rehabilitation programs and recovery from a variety of musculoskeletal conditions. Therefore, factors that strengthen adherence to ET may increase its efficacy for NSLBP. Converging evidence from recent studies suggest that control and choice may increase adherence to various treatments.

Therefore, the purpose of this study is to evaluate the effect of patient choice and preference on adherence and efficacy of exercise for recovery from NSLBP.

Design: Matched case control study. Participants: Fifty subjects with chronic (>3 months) NSLBP. Twenty-five participants will be allocated to exercise by preference group, and 25 aged and gender controls will be allocated to exercise group.

Inclusion criteria:

1. Non-specific low back pain (pain or discomfort in the lumbosacral area, with or without symptoms to the lower extremities), diagnosed by general physician or orthopedic surgeon.

2. Age 18-35

3. Chronic pain (greater than 3 months' duration).

Exclusion Criteria:

1. Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents).

2. Previous (last three years) ET treatment for NSLBP.

3. Regularly performing exercise more than WHO's recommendation:

• 150 minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.

• Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week.

Procedure: After initial assessment, participants in the intervention group will be asked to choose 3-4 items from a list of 10 general exercises - intended for treatment of low back pain. Each matched participant in the control group will receive the same exercise (without the option to choose). Participants will be instructed to perform their exercises three times a week, for a period of four weeks (12 sessions total).

Outcomes: Oswestry Disability Index (ODI) Henry-Eckert Performance Assessment Tool (HEPA) Both measurements will be taken on the first and last meeting. Additionally, each participant will fill a personal weekly exercise log (selecting between complete \ incomplete \ lack of execution) - sent by e-mail.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Non-specific low back pain (pain or discomfort in the lumbosacral area, with or without symptoms to the lower extremities), diagnosed by general physician or orthopedic surgeon.

2. Age 18-35

3. Chronic pain (greater than 3 months' duration).

Exclusion Criteria:

1. Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents).

2. Previous (last three years) ET treatment for NSLBP.

3. Regularly performing exercise more than WHO's recommendation:

• 150 minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.

• Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

Other:
• Exercise therapy
3-4 items from a list of 10 general exercises - intended for treatment of low back pain

Locations

Country	Name	City	State
Israel	Ariel University clininc	Ariel

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index (ODI)	Patient-completed questionnaire consisted of 10 items which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.; Each item consists of 6 statements scored from 0 to 5 (score of 0 indicates less disability).; The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible; 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain; 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms Minimally clinical important difference (Johnsen et al. BMC Musculoskelet Disord. 2013) = 12.88, (sensitivity 88%, specificity 85%)	Pre intervention/ At the end of the intervention (week four)
Secondary	Henry-Eckert Performance Assessment Tool (HEPA)		At the end of the intervention (week four)
Secondary	Weekly exercise log		At the end of the intervention (week four)