Skip to content

  • About CRIS
  • Search
    • Basic Search
    • Advanced Search
    • Search by Topics
      • Condition(s)/Problem(s)
      • Intervention Type
      • Phase
    • Recently Registered
    • Recently Updated
  • FAQ
  • Statistics
  • Registration Data Set

Contact Us

criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/06/17
    • Registered Date : 2019/07/12
    • Last Updated Date : 2019/07/12
Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address 815, Hwarang-ro, Nowon-gu, Seoul 
- Telephone 02-3399-3906 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
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 
Status
4. Status Status  
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 Site DESIGN HOSPITAL 
- Recruitment Status Recruiting  
- Date of First Enrollment 2019-06-11 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Sahmyook University 
- Organization Type University  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Sahmyook University 
- Organization Type Government  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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
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. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
Low Back Pain  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 30 Year ~ 65 Year
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Undecided