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Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

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ClinicalTrials.gov Identifier: NCT03984864
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shmuel Springer, Ariel University

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.


Condition or disease Intervention/treatment Phase
Low Back Pain, Recurrent Other: Exercise therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Preference Effect on Adherence and Efficacy of Exercise for Non-specific Low Back Pain
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) [ Time Frame: Pre intervention/ At the end of the intervention (week four) ]

    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%)


Secondary Outcome Measures :
  1. Henry-Eckert Performance Assessment Tool (HEPA) [ Time Frame: At the end of the intervention (week four) ]
  2. Weekly exercise log [ Time Frame: At the end of the intervention (week four) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984864


Contacts
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Contact: shmuel springer +97239066330 shmuels@ariel.ac.il

Locations
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Israel
Ariel University clininc Recruiting
Ariel, Israel
Contact: Yhonatan Levi       aramil14@gmail.com   
Contact       shmuels@ariel.ac.il   
Principal Investigator: shmuel springer         
Sponsors and Collaborators
Ariel University
Investigators
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Principal Investigator: shmuel springer Ariel University
Study Director: Yhonatan Levi Ariel University

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Responsible Party: Shmuel Springer, Head, Physical Therapy Department, Ariel University
ClinicalTrials.gov Identifier: NCT03984864     History of Changes
Other Study ID Numbers: AU-HEA-SS-20190522
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms