Clinical trial NCT03984864: Preference, Exercise Therapy Adherence and Efficacy Low Back Pain
Official title: Patient Preference Effect on Adherence and Efficacy of Exercise for Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Recurrent
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Pre intervention/ At the end of the intervention (week four)
Secondary outcomes:
measure: Henry-Eckert Performance Assessment Tool (HEPA)
timeFrame: At the end of the intervention (week four)
measure: Weekly exercise log
timeFrame: At the end of the intervention (week four)
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University clininc
Study officials:
affiliation: Ariel University
name: shmuel springer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ariel University
name: Yhonatan Levi
role: STUDY_DIRECTOR
References: