Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality
Primary Purpose
Low Back Pain, Recurrent
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
GC group
CG group
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Recurrent
Eligibility Criteria
Inclusion Criteria:
- non-specific LBP (from inferior rib margin to the gluteal fold)
- more than 3 months
- Visual Analog Scale ≧5 (in past one month)
- pelvic innominate rotation (anterior rotation in dominant side)
Exclusion Criteria:
- history of fracture or surgery
- congenital anomalies in the spine, pelvis, or lower limbs
- recent trauma, tumor, pregnancy or scoliosis
- lower extremity paresthesia, unknown weakness
- bowel and bladder dysfunction
- predominant lower extremity pain with standing
- presence of system illness, no reasoning weight loss, predominant night pain
- specific sacroiliac joint dysfunction
Sites / Locations
- National Yang Ming University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GC group
CG group
Arm Description
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.
It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.
Outcomes
Primary Outcome Measures
Leg Length Inequality
functional leg length inequality
Ilium Anterior Tilt Difference
bilateral ilium anterior tilt difference
Pelvic Inclination
bilateral pelvic inclination
Secondary Outcome Measures
Pain Intensity
Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome
Functional Disability
Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome
Functional Ability
PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome
Full Information
NCT ID
NCT03554746
First Posted
May 30, 2018
Last Updated
September 17, 2019
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT03554746
Brief Title
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality
Official Title
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality: A Ramdomized Controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GC group
Arm Type
Experimental
Arm Description
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.
Arm Title
CG group
Arm Type
Experimental
Arm Description
It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.
Intervention Type
Other
Intervention Name(s)
GC group
Other Intervention Name(s)
Additional gluteal muscle control training
Intervention Description
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
Stretching ex. : hold 15 s/reps, 5 reps/times
Hamstring
Quadriceps
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:
maintain 3rd to 4th ex.
single leg standing on rock board to maintain balance 6th:
maintain 5th ex.
lunge ex. without hip internal rotation
Intervention Type
Other
Intervention Name(s)
CG group
Other Intervention Name(s)
General core strengthening
Intervention Description
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
Stretching ex. : hold 15 s/reps, 5 reps/times
Hamstring
Quadriceps
Primary Outcome Measure Information:
Title
Leg Length Inequality
Description
functional leg length inequality
Time Frame
change from baseline at 6 weeks later
Title
Ilium Anterior Tilt Difference
Description
bilateral ilium anterior tilt difference
Time Frame
change from baseline at 6 weeks later
Title
Pelvic Inclination
Description
bilateral pelvic inclination
Time Frame
change from baseline at 6 weeks later
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome
Time Frame
change from baseline at 6 weeks later
Title
Functional Disability
Description
Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome
Time Frame
change from baseline at 6 weeks later
Title
Functional Ability
Description
PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome
Time Frame
change from baseline at 6 weeks later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-specific LBP (from inferior rib margin to the gluteal fold)
more than 3 months
Visual Analog Scale ≧5 (in past one month)
pelvic innominate rotation (anterior rotation in dominant side)
Exclusion Criteria:
history of fracture or surgery
congenital anomalies in the spine, pelvis, or lower limbs
recent trauma, tumor, pregnancy or scoliosis
lower extremity paresthesia, unknown weakness
bowel and bladder dysfunction
predominant lower extremity pain with standing
presence of system illness, no reasoning weight loss, predominant night pain
specific sacroiliac joint dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Fen Shih, PhD
Organizational Affiliation
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
Official's Role
Study Director
Facility Information:
Facility Name
National Yang Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan
12. IPD Sharing Statement
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Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality
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