Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain, Recurrent
• Intervention / Treatment: Other: Exercise therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel
    • Recruiting
    • Ariel University clininc
    • Contact: Yhonatan Levi; Email: aramil14@gmail.com
    • Contact: Email: shmuels@ariel.ac.il
    • Principal Investigator: shmuel springer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise therapy Chosen	Other: Exercise therapy; 3-4 items from a list of 10 general exercises - intended for treatment of low back pain
Active Comparator: Exercise therapy no Chosen	Other: Exercise therapy; 3-4 items from a list of 10 general exercises - intended for treatment of low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Henry-Eckert Performance Assessment Tool (HEPA)	At the end of the intervention (week four)
Weekly exercise log	At the end of the intervention (week four)

Collaborators and Investigators

• Sponsor: Ariel University
• Investigators: Principal Investigator: shmuel springer, Ariel University; Study Director: Yhonatan Levi, Ariel University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: AU-HEA-SS-20190522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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