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
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
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 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
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
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Sahmyook University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Sahmyook University |
Organization Type | Government |
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. |
---|
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 | 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
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)
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
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동