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Effects of Core Stabilization Exercise and Hip-targeted Muscles Stretching and Strengthening Exercise on Physical Function and Activity in Patients with Non-specific Low Back Pain: A Randomized Controlled Trial

Status Approved

  • First Submitted Date

    2019/06/17

  • Registered Date

    2019/07/12

  • Last Updated Date

    2019/07/12

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004140
    Unique Protocol ID 2-7001793-AB-N-012019047HR
    Public/Brief Title Effects of Core Stabilization Exercise and Hip-targeted Muscles Stretching and Strengthening Exercise on Physical Function and Activity in Patients with Non-specific Low Back Pain
    Scientific Title Effects of Core Stabilization Exercise and Hip-targeted Muscles Stretching and Strengthening Exercise on Physical Function and Activity in Patients with Non-specific Low Back Pain: A Randomized Controlled Trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2-7001793-AB-N-012019047HR
    Approval Date 2019-06-11
    Institutional Review Board Name Institutional Review Board of the Sahmyook University
    Institutional Review Board Address 815, Hwarang-ro, Nowon-gu, Seoul
    Institutional Review Board Telephone 02-3399-3906
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Beom Ryong Kim
    Title PT
    Telephone +82-63-240-2520
    Affiliation Sahmyook University
    Address 815 Hwarang-ro, Nowon-gu, Seoul
    Contact Person for Public Queries
    Name Beom Ryong Kim
    Title PT
    Telephone +82-63-240-2520
    Affiliation Sahmyook University
    Address 815 Hwarang-ro, Nowon-gu, Seoul
    Contact Person for Updating Information
    Name Beom Ryong Kim
    Title PT
    Telephone +82-63-240-2520
    Affiliation Sahmyook University
    Address 815 Hwarang-ro, Nowon-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-06-11 Actual
    Target Number of Participant 75
    Primary Completion Date 2019-12-31 , Anticipated
    Study Completion Date 2019-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Desing Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-06-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Sahmyook University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Sahmyook University
    Organization Type Government
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    It is a treatment for the hip as an adjunctive intervention method for nonspecific low back pain (LBP) patients. Especially in patients with hip and LBP. The concept of hip-spine syndrome was introduced 30 years ago. It is also frequently cited in the literature. This concept assumes that there are distinct obstacles in the two areas. One part in the hip (osteoarthritis), one part in the back (stenosis). Two site problems cause more problems at each site. The hypothesis is that one area of ​​treatment can improve pain and function in untreated areas. The relationship between hip and waist has a different function, but in fact it has one unified function. These correlations make it possible for musculoskeletal symptoms to be affected directly or indirectly by disturbances of adjacent joints. Older people with chronic LBP are more likely to have hip joint pain, morning stiffness, and LBP in the hip. LBP patients with hip osteoarthritis reported improved LBP and spinal function after hip arthroplasty.
    The results of the studies comparing the muscle strength of the hip muscles with those of the healthy controls in nonspecific LBP patients showed that the strength of the hip, bending and extensors muscles was significantly lower in patients with LBP than in the healthy controls, There have been studies that reported weakening of muscle strength, weakness of hip flexion muscle strength, weakness of hip muscle strength. Thus, it can be seen that the hip muscle is weaker than the normal adult in the LBP patient.
    A study of hip-strengthening exercises in patients with nonspecific LBP revealed a decrease in LBP and disability levels by applying waist pelvic exercise and hip strengthening exercises, core stabilization exercises and hip motion exercises , Hip flexion strengthening and core stabilization exercise to improve LBP disability and lumbar muscle strength and balance ability. The results of applying hip and strengthening with waist treatment showed positive changes in pain, disability, and patient satisfaction. It is a reported study. Recently, a systematic review and a meta-analysis were reported on the subject of hip-target interventions affecting LBP patients. The study, reported as hip-target intervention, is mostly in rheumatoid arthritis, which includes exercise and hip surgery to strengthen muscle around the hips. Studies on the LBP and disability by extending the muscles around the hips were not considered. However, in the patients with LBP, they showed improvement in pain reduction and work ability by applying core stabilization exercise and femoral muscle extension exercise. In patients with LBP, the length of the muscles behind the femur is reduced. We report a decrease in the range of pelvic tilt with increasing muscle length after femur. Pelvic tilt in patients with LBP is affected by hip. 
    The degree of LBP and disability were reported to be related to the hip muscles. We report a decrease in pain and pelvic tilt angles and an increase in muscle activity and hip flexor muscle length by applying waist-to-hip flexion to LBP patients with pelvic tilt. The piriformis is one of the muscles of the hip joints. The presence of LBP increases the size of the piriformis, and the LBP patient has a limitation of hip joint rotation. The cause of back pain was the tensor fasciae latae. stretching exercises of the tensor fasciae latae  improve the range of motion of the hips and pelvis and help reduce LBP and disability.
    The results of this study suggest that the use of the core stabilization exercise and the hip target intervention method for the elderly should be used for the LBP patients. The purpose of this study was to investigate the effect of core stabilization exercise and total hip stretching exercise on body function (pain, ROM) and activity (disability, quality, balance) in patients with nonspecific LBP.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Others (exercise)
    Intervention Description
    Patients with nonspecific back pain who have agreed to participate actively in the study should be informed. These were each randomly assigned: Control group, in which core stabilization exercise (30 minutes) and sham treatment (15 minutes), Experimental group Ⅰ, in which core stabilization exercise (30 minutes) and hip muscle strengthening exercise (15 minutes), Experimental group II, in which core stabilization (30 minutes) and hip muscle stretching exercise (15 minutes).
     
    Core Stabilization Exercise: All groups receive a core stabilization exercise consisting of 30 minutes for 6 weeks three times a week. Each exercise maintains an isometric contraction of 7 to 8 seconds. Each exercise is repeated 10 times. It provides a short break time of 3 seconds between repetitions. There is a one minute break between each exercise. Every time you repeat all exercises, the patient shrinks the abdominal muscles. Ask to maintain contraction while maintaining normal breathing patterns. The core stabilization movements are Abdominal hollowing, Side bridge, Supine extension bridge, Straight leg rise from prone, Alternate arm and leg raise from quadruped, Prone bridge.
    
    sham treatment: the control group receives an additional 15 minutes of false-positive treatment for 6 weeks 3 times a week. The therapist lightly touches the skin of the back of the subject's spine and does not mediate. Subjects do not know that they are included in the control group. At the time of intervention, the patient should be made aware that he or she is actually receiving treatment.
    
    Hip Muscle Strengthening Exercise is additionally subjected to a hip muscle strengthening exercise consisting of 15 minutes for 6 weeks three times a week. All hip muscle strengthening movements should be held for 30 seconds in maximum contracted condition, then returned to their place and rest for 10 seconds. This operation is repeated three times. Side-lying hip abduction with internal rotation, Prone heel squeeze, Quadruped hip extension, Standing gluteal squeeze.
    
    Hip Muscle Stretching Exercise is additionally subjected to a hip muscle stretching exercise consisting of 15 minutes for 6 weeks three times a week. All hip muscles stretching operation back into place and then held for 30 seconds at maximum extension range and rest for 10 seconds. This operation is repeated three times. Instructs the subject to reduce the strength of the subject's body every time he or she stretches. It induces the exhalation of breath during operation. Hamstring stretching, Iliopsoas stretching, Piriformis stretching, and Tensor fasciae latae stretching are the methods of stretching the hip muscles.
    Number of Arms 3
    Arm 1

    Arm Label

    hip muscles strengthening exercises

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    Hip Muscle Strengthening Exercise is additionally subjected to a hip muscle strengthening exercise consisting of 15 minutes for 6 weeks three times a week. All hip muscle strengthening movements should be held for 30 seconds in maximum contracted condition, then returned to their place and rest for 10 seconds. This operation is repeated three times. Side-lying hip abduction with internal rotation, Prone heel squeeze, Quadruped hip extension, Standing gluteal squeeze.
    Arm 2

    Arm Label

    hip muscles stretching exercises

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    Hip Muscle Stretching Exercise is additionally subjected to a hip muscle stretching exercise consisting of 15 minutes for 6 weeks three times a week. All hip muscles stretching operation back into place and then held for 30 seconds at maximum extension range and rest for 10 seconds. This operation is repeated three times. Instructs the subject to reduce the strength of the subject's body every time he or she stretches. It induces the exhalation of breath during operation. Hamstring stretching, Iliopsoas stretching, Piriformis stretching, and Tensor fasciae latae stretching are the methods of stretching the hip muscles.
    Arm 3

    Arm Label

    sham treatment

    Target Number of Participant

    25

    Arm Type

    Sham comparator

    Arm Description

    sham treatment: the control group receives an additional 15 minutes of false-positive treatment for 6 weeks 3 times a week. The therapist lightly touches the skin of the back of the subject's spine and does not mediate. Subjects do not know that they are included in the control group. At the time of intervention, the patient should be made aware that he or she is actually receiving treatment.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M54.56)Low back pain, lumbar region 

    Low Back Pain
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    30Year~65Year

    Description

    Subjects were diagnosed with nonspecific back pain from an orthopedic surgeon. Patients who received prescription exercise therapy were also included. The subjects are those who have 3 or more months of non-specific back pain complaining at least 3 points of pain level (VAS 0-10 range).
    Exclusion Criteria
    The exclusion criteria are: (1) history of spinal surgery, (2) history of ankylosing spondylitis or rheumatoid arthritis, (3) history of spondylolisthesis or spondylolysis, (4) vertebral or pelvic fracture, (5) spinal inflammation or tumor, (6) Osteoporosis, (7) continued use of analgesics, (8) history of stroke, (9) respiratory or cardiac history, and (10) pregnancy.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Visual Analogue Scale
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 2
    Outcome
    Oswestry Disability Index
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 3
    Outcome
    Roland Morris disability questionnaires
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 4
    Outcome
    Short form 36
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 5
    Outcome
    passive straight leg raising test
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 6
    Outcome
    Toe touch test
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 7
    Outcome
    modified Thomas test
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 8
    Outcome
    Ober test
    Timepoint
    Measure before and after 6 weeks of intervention
    Primary Outcome(s) 9
    Outcome
    modified flexion adduction internal rotation test
    Timepoint
    Measure before and after 6 weeks of intervention
    Secondary Outcome(s) 1
    Outcome
    One leg standing test
    Timepoint
    Measure before and after 6 weeks of intervention
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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