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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03554746
Other study ID # YM106055F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2017
Est. completion date September 10, 2018

Study information

Verified date August 2019
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 10, 2018
Est. primary completion date July 23, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Other:
GC group
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
CG group
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

Locations

Country Name City State
Taiwan National Yang Ming University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leg Length Inequality functional leg length inequality change from baseline at 6 weeks later
Primary Ilium Anterior Tilt Difference bilateral ilium anterior tilt difference change from baseline at 6 weeks later
Primary Pelvic Inclination bilateral pelvic inclination change from baseline at 6 weeks later
Secondary 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
Secondary Functional Disability Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome change from baseline at 6 weeks later
Secondary Functional Ability PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome change from baseline at 6 weeks later
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