Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

NCT ID: NCT03984864

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-12-30

Brief 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.

Conditions

Low Back Pain, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise therapy Chosen

Group Type: EXPERIMENTAL

Exercise therapy

Intervention Type: OTHER

3-4 items from a list of 10 general exercises - intended for treatment of low back pain

Exercise therapy no Chosen

Group Type: ACTIVE_COMPARATOR

Exercise therapy

Intervention Type: OTHER

3-4 items from a list of 10 general exercises - intended for treatment of low back pain

Interventions

Exercise therapy

3-4 items from a list of 10 general exercises - intended for treatment of low back pain

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariel University

OTHER

Sponsor Role: lead

Responsible Party

Shmuel Springer

Head, Physical Therapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shmuel springer

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Yhonatan Levi

Role: STUDY_DIRECTOR

Ariel University

Locations

Ariel University clininc

Ariel, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

shmuel springer

Role: CONTACT

shmuels@ariel.ac.il

+97239066330

Facility Contacts

Yhonatan Levi

Role: primary

aramil14@gmail.com

Role: backup

shmuels@ariel.ac.il

Other Identifiers

AU-HEA-SS-20190522

Identifier Type: -

Identifier Source: org_study_id