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The Effects of Proprioceptive Neuromuscular Facilitation Training

Primary Purpose

Low Back Pain, Disability Physical

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Facilitation Training
Control Group
Sponsored by
Hacettepe 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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of non-spesific CLBP (˃3 months),
  • the ability to understand and follow verbal commands,
  • to be volunteer to participate in the study.

Exclusion Criteria:

  • to be pregnant,
  • had a previous history of spinal surgery,
  • neurological deficits,
  • specific LBP (including facet joint syndrome, disc herniation and sacroiliac joint dysfunction),
  • cancer or other autoimmune diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental-Study Group

    Control Group

    Arm Description

    In addition to the conservative treatment of the control group, proprioceptive neuromuscular facilitation techniques will be applied for 4 weeks.

    Conservative treatment of low back pain will be applied for 4 weeks.

    Outcomes

    Primary Outcome Measures

    Visual analog scale (VAS)
    The pain severity of the patients with CLBP will be measured using a 10 centimeter VAS where score of 0/10 indicated no pain and 10/10 to indicated intolerable pain, respectively. A clinically meaningful difference for the VAS is a reduction of approximately two points for patients with CLBP.

    Secondary Outcome Measures

    The Oswestry Disability Index (ODI)
    This scale is intended to measure the disability level due to CLBP. It consists of ten questions: pain intensity, personal care, lifting, walking, sitting, standing, sleep¬ing, sex life, and social life. Depending on performance ability, 6 levels (0 to 5 points) can be specified: the higher the score, the greater the disability. The ODI is calculated by dividing the total score by the number of questions answered and multiplying by 100. The participants will be asked whether any statements characterized them on evaluation day. The Turkish version of ODI has good comprehensibility, internal consistency, and validity and is an adequate and useful instrument for the assessment of disability in patients with low back pain (internal consistency=0.89-0.91). The minimal detectable change on the ODI is 6-10 points. Clinically meaningful change is considered to be 30-50%.
    The Schober Test
    The Schober Test will be used for the assessment of lumbar flexion range of motion (ROM) of the patients with CLBP. In relaxed standing position, the mid-point between the two posterior superior iliac spines will be determined. Then, 5 centimeter above and 5 centimeter below this point will be marked as measurement points. At this stage, patients will be asked to bend forwardly as much as possible while maintaining their knees as straight as possible. The difference between the two points in this position in comparison to distance between the points in relaxed standing position will be considered as the lumbar flexion ROM.
    The Prone Doubled Leg Straight Leg Raising (SLR)
    SLR will be used for the evaluation of back extensor muscle endurance of the patients with CLBP. Participants lay in prone position with their hips extended, putting their hands underneath their foreheads. They will be asked to raise both of their legs until knee clearance will be achieved. At this stage the examiner will record the time until the participant will no longer able to keep knee clearance. The recorded time in seconds will be considered as back extensor muscle endurance.
    Ultrasonographic Imaging
    Ultrasonographic imaging will be conducted by a radiologist (experience˃15 years) to determine muscle thickness of diaphragm. Thickness of both hemidiaphragm will be measured at the end of expiration from transvers and sagittal images obtained at the 9th intercostal space on anterior axillary line.

    Full Information

    First Posted
    November 25, 2019
    Last Updated
    November 25, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04178356
    Brief Title
    The Effects of Proprioceptive Neuromuscular Facilitation Training
    Official Title
    The Effects of Proprioceptive Neuromuscular Facilitation Training on Pain, Range of Motion, Functional Disability Index, Back Extensor Muscle Endurance, and Diaphragm Muscle Thickness in Patients With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 20, 2019 (Anticipated)
    Primary Completion Date
    March 20, 2020 (Anticipated)
    Study Completion Date
    April 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe 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
    Although various methods have been emphasized in the treatment of chronic low back pain (CLBP), one of the treatments with the highest level of evidence is tailor-made exercises. Exercises to improve lumbopelvic region muscle performance and proprioception have been reported to be effective in alleviating clinical symptoms in individuals with CLBP. Proprioceptive neuromuscular facilitation (PNF) techniques are frequently used in the treatment of CLBP. PNF techniques reduce the load on vertebral bodies when performed in supine, side-lying, and sitting positions. It has been reported that performing a PNF trunk pattern in a sitting position is effective for treating CLBP and it improves muscle endurance, flexibility, and functional performance. PNF lower extremity pattern training in a supine position is effective for abdominal muscle activation. There is also an improvement in pain, functional disability, and fear-avoidance belief by applying the PNF coordination pattern in a standing position. While the diaphragm effect was emphasized in individuals with CLBP, no studies examining the effect of PNF techniques used on CLBP treatment on diaphragm muscle thickness were found. In addition, studies investigating the effect of PNF techniques on pain, functional disability index, range of motion and waist muscle endurance were found to be insufficient. Therefore, the aim of this study was to investigate the effect of PNF techniques on related variables in individuals with CLBP.
    Detailed Description
    It is known that dorsal proprioceptive signals, one of the necessary components in providing lumbopelvic motor control, are decreased in individuals with chronic low back pain (CLBP) and respiratory dysfunction. Diaphragm, which is an important postural control muscle, plays an important role in the correct reception of these signals. Electromyographic and ultrasonographic measurements in healthy subjects showed that the diaphragm was activated for anticipatory automatic adjustments before shoulder flexion, adjusted the transdiaphragmatic pressure and shortened the neck before motion began. In CLBP, diaphragm motility decreases significantly due to fatigue in the diaphragm. This makes it difficult to perform anticipatory automatic arrangements, leading to postural instability and respiratory dysfunction. Although various methods have been emphasized in the treatment of CLBP, one of the treatments with the highest level of evidence is tailor-made exercises. Exercises to improve lumbopelvic region muscle performance and proprioception have been reported to be effective in alleviating clinical symptoms in individuals with CLBP. Proprioceptive neuromuscular facilitation (PNF) techniques are frequently used in the treatment of CLBP. PNF techniques reduce the load on vertebral bodies when performed in supine, side-lying, and sitting positions. It has been reported that performing a PNF trunk pattern in a sitting position is effective for treating CLBP and it improves muscle endurance, flexibility, and functional performance. PNF lower extremity pattern training in a supine position is effective for abdominal muscle activation. There is also an improvement in pain, functional disability, and fear-avoidance belief by applying the PNF coordination pattern in a standing position. While the diaphragm effect was emphasized in individuals with CLBP, no studies examining the effect of PNF techniques used on CLBP treatment on diaphragm muscle thickness were found. In addition, studies investigating the effect of PNF techniques on pain, functional disability index, range of motion and waist muscle endurance were found to be insufficient. Therefore, the aim of this study was to investigate the effect of PNF techniques on related variables in individuals with CLBP.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized
    Masking
    Care Provider
    Masking Description
    Single blinded
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental-Study Group
    Arm Type
    Experimental
    Arm Description
    In addition to the conservative treatment of the control group, proprioceptive neuromuscular facilitation techniques will be applied for 4 weeks.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Conservative treatment of low back pain will be applied for 4 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Proprioceptive Neuromuscular Facilitation Training
    Intervention Description
    The Proprioceptive Neuromuscular Facilitation Training will be performed using patterns and techniques in various positions for abdominal and back muscles' facilitation and strengthening. Supine, side-lying, and sitting positions will be used. There will be a rest of about 20 sec between sets. Warm-up for 10 min, main exercises for 25 min, cool-down for 10 min (a total of 45 min), 5 times a week for 4 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Control Group
    Intervention Description
    Ultrasound, TENS, massage, and exercise will be used with each other because in most of the physical therapy clinics these modalities are used together for such problems as a conventional treatment. After massage application, hamstring and paravertebral muscles stretching and also stabilizing exercises will be prescribed, each one for ten times in each session.
    Primary Outcome Measure Information:
    Title
    Visual analog scale (VAS)
    Description
    The pain severity of the patients with CLBP will be measured using a 10 centimeter VAS where score of 0/10 indicated no pain and 10/10 to indicated intolerable pain, respectively. A clinically meaningful difference for the VAS is a reduction of approximately two points for patients with CLBP.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    The Oswestry Disability Index (ODI)
    Description
    This scale is intended to measure the disability level due to CLBP. It consists of ten questions: pain intensity, personal care, lifting, walking, sitting, standing, sleep¬ing, sex life, and social life. Depending on performance ability, 6 levels (0 to 5 points) can be specified: the higher the score, the greater the disability. The ODI is calculated by dividing the total score by the number of questions answered and multiplying by 100. The participants will be asked whether any statements characterized them on evaluation day. The Turkish version of ODI has good comprehensibility, internal consistency, and validity and is an adequate and useful instrument for the assessment of disability in patients with low back pain (internal consistency=0.89-0.91). The minimal detectable change on the ODI is 6-10 points. Clinically meaningful change is considered to be 30-50%.
    Time Frame
    4 weeks
    Title
    The Schober Test
    Description
    The Schober Test will be used for the assessment of lumbar flexion range of motion (ROM) of the patients with CLBP. In relaxed standing position, the mid-point between the two posterior superior iliac spines will be determined. Then, 5 centimeter above and 5 centimeter below this point will be marked as measurement points. At this stage, patients will be asked to bend forwardly as much as possible while maintaining their knees as straight as possible. The difference between the two points in this position in comparison to distance between the points in relaxed standing position will be considered as the lumbar flexion ROM.
    Time Frame
    4 weeks
    Title
    The Prone Doubled Leg Straight Leg Raising (SLR)
    Description
    SLR will be used for the evaluation of back extensor muscle endurance of the patients with CLBP. Participants lay in prone position with their hips extended, putting their hands underneath their foreheads. They will be asked to raise both of their legs until knee clearance will be achieved. At this stage the examiner will record the time until the participant will no longer able to keep knee clearance. The recorded time in seconds will be considered as back extensor muscle endurance.
    Time Frame
    4 weeks
    Title
    Ultrasonographic Imaging
    Description
    Ultrasonographic imaging will be conducted by a radiologist (experience˃15 years) to determine muscle thickness of diaphragm. Thickness of both hemidiaphragm will be measured at the end of expiration from transvers and sagittal images obtained at the 9th intercostal space on anterior axillary line.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: presence of non-spesific CLBP (˃3 months), the ability to understand and follow verbal commands, to be volunteer to participate in the study. Exclusion Criteria: to be pregnant, had a previous history of spinal surgery, neurological deficits, specific LBP (including facet joint syndrome, disc herniation and sacroiliac joint dysfunction), cancer or other autoimmune diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caner KARARTI, PT, MSc.
    Phone
    03862805362
    Email
    fzt.caner.92@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Çağdaş BASAT, Assoc. Prof.
    Phone
    +905057721489
    Email
    cagdasbasat@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27501326
    Citation
    Beeckmans N, Vermeersch A, Lysens R, Van Wambeke P, Goossens N, Thys T, Brumagne S, Janssens L. The presence of respiratory disorders in individuals with low back pain: A systematic review. Man Ther. 2016 Dec;26:77-86. doi: 10.1016/j.math.2016.07.011. Epub 2016 Jul 25.
    Results Reference
    result
    PubMed Identifier
    27791345
    Citation
    Areeudomwong P, Wongrat W, Neammesri N, Thongsakul T. A randomized controlled trial on the long-term effects of proprioceptive neuromuscular facilitation training, on pain-related outcomes and back muscle activity, in patients with chronic low back pain. Musculoskeletal Care. 2017 Sep;15(3):218-229. doi: 10.1002/msc.1165. Epub 2016 Oct 28.
    Results Reference
    result
    PubMed Identifier
    16813479
    Citation
    Kofotolis N, Kellis E. Effects of two 4-week proprioceptive neuromuscular facilitation programs on muscle endurance, flexibility, and functional performance in women with chronic low back pain. Phys Ther. 2006 Jul;86(7):1001-12.
    Results Reference
    result

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    The Effects of Proprioceptive Neuromuscular Facilitation Training

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