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Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

Primary Purpose

Low Back Pain, Recurrent

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
Ariel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Recurrent

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ariel University clinincRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise therapy Chosen

Exercise therapy no Chosen

Arm Description

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

Henry-Eckert Performance Assessment Tool (HEPA)
Weekly exercise log

Full Information

First Posted
June 10, 2019
Last Updated
March 8, 2020
Sponsor
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT03984864
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. Age 18-35 Chronic pain (greater than 3 months' duration). Exclusion Criteria: Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents). Previous (last three years) ET treatment for NSLBP. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy Chosen
Arm Type
Experimental
Arm Title
Exercise therapy no Chosen
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
3-4 items from a list of 10 general exercises - intended for treatment of low back pain
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI)
Description
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%)
Time Frame
Pre intervention/ At the end of the intervention (week four)
Secondary Outcome Measure Information:
Title
Henry-Eckert Performance Assessment Tool (HEPA)
Time Frame
At the end of the intervention (week four)
Title
Weekly exercise log
Time Frame
At the end of the intervention (week four)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age 18-35 Chronic pain (greater than 3 months' duration). Exclusion Criteria: Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents). Previous (last three years) ET treatment for NSLBP. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shmuel springer
Phone
+97239066330
Email
shmuels@ariel.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shmuel springer
Organizational Affiliation
Ariel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yhonatan Levi
Organizational Affiliation
Ariel University
Official's Role
Study Director
Facility Information:
Facility Name
Ariel University clininc
City
Ariel
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yhonatan Levi
Email
aramil14@gmail.com
Ext
springer
Email
shmuels@ariel.ac.il
First Name & Middle Initial & Last Name & Degree
shmuel springer

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

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