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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
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Recurrent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 30, 2018
Last Updated
September 17, 2019
Sponsor
National Yang Ming University
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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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