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Advice of Staying Active for Sub Acute Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be included if they are between 18 - 65 years of age
  • able to stand and walk without assistance.
  • Patients will also be included if they have a history of non specific low back pain classified as low risk of poor outcome with a total score of three or less based on the STarT Back Tool score (Hill et al., 2008).
  • The back-pain episode is subacute

Exclusion Criteria:

  • Patients will be excluded if they have any neurological disease or balance deficits due to vestibular disorders, such as vertebrobasilar insufficiency and visual disorders,
  • systemic infection,
  • current pregnancy,
  • severe musculoskeletal deformity (scoliosis or kyphosis),
  • injury to the lower extremity that would interfere with testing or a history of any surgery in the three months prior to testing.
  • Patients will also be excluded if they have pain below the knee consistent with a disc herniation, presence of neurological signs, serious spinal complications (e.g., vertebral fracture, tumor or infection),
  • spinal stenosis,
  • confounding conditions such as extreme obesity, severe scoliosis, significant anatomical leg length inequality, previous spinal surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    advice of staying active

    walking program

    Backward walking

    Targeted home-based hip exercise

    control group

    Arm Description

    The patients will be advised to stay as physically active as possible and continue their everyday activities as normally as possible.

    Patients will be encouraged to go about their normal daily activities. At week one, patients will be asked to familiarize themselves with wearing the pedometer and recording their daily steps in a walking diary for the subsequent 7 days. The patients will return to see the physiotherapist at the end of week one to discuss any issues with the program, pedometer or recording of desired information. A step target for week two will be agreed between the physiotherapist and the patient by referring to the mean daily step count recorded at baseline, and the average step count calculated from the walking diary

    All patients will be instructed to walk at their desired pace 3 days per week with a steady rhythm. The duration of each training session will initially be 15 minutes and will gradually increase, and finally reach 25 minutes, for every session (Hao Chen, 2011). There will be no constraint or indication about head and trunk position during backward training

    Patients who will be assigned in this group will perform a hip exercise program for six weeks, three times / week to ensure an adequate recovery between exercise sessions (appendix V). The strengthening exercises will focus on strengthening the gluteus maximus (GMax), gluteus medius (GMed), gluteus minimus (GMin) and short hip external rotator muscles (Distefano et al., 2009).

    The patients will not be given any intervention and will be asked to come after 6 weeks for re-assessment

    Outcomes

    Primary Outcome Measures

    level of perceived pain by Visual analogue scale
    The Visual analogue scale will be used for measuring the pain intensity the scale ranges from 0 to 10 where 0 means no pain and 10 means severe intolerable pain.

    Secondary Outcome Measures

    number of steps
    A spring-leverd pedometer (Yamax Digiwalker CW-701, Yamax, Japan) will be used to assess the number of steps. The number of steps will be used as an indicator for the level of physical activity

    Full Information

    First Posted
    March 23, 2020
    Last Updated
    March 24, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04320654
    Brief Title
    Advice of Staying Active for Sub Acute Low Back Pain
    Official Title
    Will Patients With Low Back Pain Benefit From the Advice of Staying Active
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The variabilities in the management approaches for patients with LBP reflect uncertainty about the optimal approach. Therefore, there is a need for the implementation of early treatment strategies relying on an evidence-based knowledge to treat the problems and reduce the risk for recurrence and chronicity of LBP. Advice is considered as the 'first in line' for the treatment of patients with LBP and is recommended in all international guidelines, yet it is under-utilized by the general practitioners. The current evidence in favor for the advice of staying active for patients with LBP is limited, with small or no benefits in pain relief, functional improvement or sick leave compared to rest in bed. Consequently, there is a huge gap between the evidence and practice. So, the current study aimed at filling this gap and expanding the previous findings by investigating the effect of the advice of staying active on the level of perceived pain, physical activity level, postural control and functional disability in patients with low risk LBP (with a total score of three or less based on the STarT Back Tool score).
    Detailed Description
    In spite of the great effort, LBP remains a significant burden on the society and can cause a disturbing impact on the functional ability during the productive years of the individuals. It is important to find pragmatic treatments that not only reduce the pain, but also decrease the disability. Activity monitoring in real life has the potential to change our concept of outcomes, and as a result, expand our ideas about the appropriateness of the interventions in rehabilitation. The international guidelines vary but agree on advising patients with LBP to remain physically active. The National Institute for Clinical Excellence (NICE)'s updated guideline on the LBP recommends encouraging people to continue with their normal activities as far as possible. NICE found that there were no randomized controlled trials (RCTs) (which are the best way of investigating the efficacy of a treatment) that compared the effect of the advice of staying active with no advice or the advice to rest. Despite the guidelines, it was reported that many health care providers are still too restrictive and believe that LBP requires some avoidance of activities and to remain off- work. Many general practitioners do not give advice on daily activities to patients with back pain and there is confusion about what constitutes an effective advice. Only 12% of the physiotherapists identify correctly the guidelines, and most of them do not agree with these guidelines regarding the return to work or activity. Investigating the benefit of the advice of staying active and different active intervention programs in patients with low risk NSLBP may help in developing recommendations for the physiotherapists responsible for reviewing exercise protocols for patients with LBP. Therefore, the improvement of the primary care management of patients with LBP has the potential to reduce the long-term effects of back pain, including persistent disabling symptoms, low quality of life, and reduced capacity to work. The advice of staying active may not only be a treatment to improve the recovery from LBP, but also an opportunity to promote physical activity for other health benefits, such as improved cardio-metabolic function, blood pressure, and reduced body fatness.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    different groups each will receive specific intervention at the same time
    Masking
    Participant
    Masking Description
    sealed envelopes
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    advice of staying active
    Arm Type
    Experimental
    Arm Description
    The patients will be advised to stay as physically active as possible and continue their everyday activities as normally as possible.
    Arm Title
    walking program
    Arm Type
    Experimental
    Arm Description
    Patients will be encouraged to go about their normal daily activities. At week one, patients will be asked to familiarize themselves with wearing the pedometer and recording their daily steps in a walking diary for the subsequent 7 days. The patients will return to see the physiotherapist at the end of week one to discuss any issues with the program, pedometer or recording of desired information. A step target for week two will be agreed between the physiotherapist and the patient by referring to the mean daily step count recorded at baseline, and the average step count calculated from the walking diary
    Arm Title
    Backward walking
    Arm Type
    Experimental
    Arm Description
    All patients will be instructed to walk at their desired pace 3 days per week with a steady rhythm. The duration of each training session will initially be 15 minutes and will gradually increase, and finally reach 25 minutes, for every session (Hao Chen, 2011). There will be no constraint or indication about head and trunk position during backward training
    Arm Title
    Targeted home-based hip exercise
    Arm Type
    Experimental
    Arm Description
    Patients who will be assigned in this group will perform a hip exercise program for six weeks, three times / week to ensure an adequate recovery between exercise sessions (appendix V). The strengthening exercises will focus on strengthening the gluteus maximus (GMax), gluteus medius (GMed), gluteus minimus (GMin) and short hip external rotator muscles (Distefano et al., 2009).
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The patients will not be given any intervention and will be asked to come after 6 weeks for re-assessment
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    The aim of this intervention is to increase patients average daily step count. The walking program is a behavior change intervention in which the pedometer will be used as a tool to help the patients monitor their activity levels.
    Primary Outcome Measure Information:
    Title
    level of perceived pain by Visual analogue scale
    Description
    The Visual analogue scale will be used for measuring the pain intensity the scale ranges from 0 to 10 where 0 means no pain and 10 means severe intolerable pain.
    Time Frame
    six weeks
    Secondary Outcome Measure Information:
    Title
    number of steps
    Description
    A spring-leverd pedometer (Yamax Digiwalker CW-701, Yamax, Japan) will be used to assess the number of steps. The number of steps will be used as an indicator for the level of physical activity
    Time Frame
    six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients will be included if they are between 18 - 65 years of age able to stand and walk without assistance. Patients will also be included if they have a history of non specific low back pain classified as low risk of poor outcome with a total score of three or less based on the STarT Back Tool score (Hill et al., 2008). The back-pain episode is subacute Exclusion Criteria: Patients will be excluded if they have any neurological disease or balance deficits due to vestibular disorders, such as vertebrobasilar insufficiency and visual disorders, systemic infection, current pregnancy, severe musculoskeletal deformity (scoliosis or kyphosis), injury to the lower extremity that would interfere with testing or a history of any surgery in the three months prior to testing. Patients will also be excluded if they have pain below the knee consistent with a disc herniation, presence of neurological signs, serious spinal complications (e.g., vertebral fracture, tumor or infection), spinal stenosis, confounding conditions such as extreme obesity, severe scoliosis, significant anatomical leg length inequality, previous spinal surgery.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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