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Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs.
Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs. Some authors consider that this type of low back pain may be caused by leg length inequality (LLI) in these patients, which resulted from poor gluteal neuromuscular control or muscles' imbalance.
In consideration of few studies have been done for investigating the effects of gluteal muscles control training in LBP. Thus, the purpose of this study is to investigate the effect of additional gluteal muscles control training on improving functional LLI in patients with LBP. We hypothesized that gluteal muscle control training would be more effective in self-reported pain, and their functional disability would be improve after 6-week training program than control training group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC group | Experimental | It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks. |
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| CG group | Experimental | It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC group | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leg Length Inequality | functional leg length inequality | change from baseline at 6 weeks later |
| Ilium Anterior Tilt Difference | bilateral ilium anterior tilt difference | change from baseline at 6 weeks later |
| Pelvic Inclination | bilateral pelvic inclination | change from baseline at 6 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome | change from baseline at 6 weeks later |
| Functional Disability | Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Fen Shih, PhD | Department of Physical Therapy and Assistive Technology, National Yang-Ming University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Yang Ming University | Taipei | 11221 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | GC Group | It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks. GC group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times 1st to 2nd: clam ex. without resistance single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th: a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th: maintain 5th ex. lunge ex. without hip internal rotation |
| FG001 | CG Group | It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. CG group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GC Group | It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks. GC group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times 1st to 2nd: clam ex. without resistance single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th: a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th: maintain 5th ex. lunge ex. without hip internal rotation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leg Length Inequality | functional leg length inequality | Posted | Mean | Standard Deviation | centemeter | change from baseline at 6 weeks later |
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The time frame is 9 months (Study Start Date: December 11, 2017 to the Study Completion Date: September 10, 2018). After all the included participants complete the intervention and pre/post tests.
Results submission is required by FDAAA 801 for certain applicable clinical trials of drugs, biologics and devices.
This study was an exercise intervention for low back pain patients. We didn't use any drugs, biologics and devices.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CG Group | It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. CG group: 1. core stability training: hold 5s/rep, 20 reps/times
a. Hamstring b. Quadriceps |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yi-Fen Shih | National Yang Ming University | +886-2-28267340 | yfshih@ym.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2018 | Jun 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| CG group | Other |
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| change from baseline at 6 weeks later |
| Functional Ability | PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome | change from baseline at 6 weeks later |
| BG001 | CG Group | IIt involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. CG group: 1. core stability training: hold 5s/rep, 20 reps/times supine, pelvic posterior tilt with TrA contraction. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | CG Group | It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. CG group: 1. core stability training: hold 5s/rep, 20 reps/times
a. Hamstring b. Quadriceps |
|
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| Primary | Ilium Anterior Tilt Difference | bilateral ilium anterior tilt difference | Posted | Mean | Standard Deviation | degrees | change from baseline at 6 weeks later |
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| Primary | Pelvic Inclination | bilateral pelvic inclination | Posted | Mean | Standard Deviation | degrees | change from baseline at 6 weeks later |
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| Secondary | Pain Intensity | Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome | Posted | Mean | Standard Deviation | score on a scale | change from baseline at 6 weeks later |
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| Secondary | Functional Disability | Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome | Posted | Mean | Standard Deviation | score on a scale | change from baseline at 6 weeks later |
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| Secondary | Functional Ability | PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome | Posted | Mean | Standard Deviation | score on a scale | change from baseline at 6 weeks later |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | GC Group | It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks. GC group: 1. core stability training: hold 5s/rep, 20 reps/times
a. Hamstring b. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times 1st to 2nd:
a. maintain 3rd to 4th ex. b. single leg standing on rock board to maintain balance 6th:
| 0 | 24 | 0 | 24 | 0 | 24 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |