Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality

• ClinicalTrials.gov Identifier: NCT03554746
• Recruitment Status: Completed
• First Posted: June 13, 2018
• Results First Posted: September 19, 2019
• Last Update Posted: September 19, 2019
• Sponsor: National Yang Ming University
• Information provided by (Responsible Party): Yi-Fen Shih, National Yang Ming University

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain, Recurrent	Other: GC group; Other: CG group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality: A Ramdomized Controlled Trail
• Actual Study Start Date: December 11, 2017
• Actual Primary Completion Date: July 23, 2018
• Actual Study Completion Date: September 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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; Other Name: Additional gluteal muscle control training
Experimental: 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.	Other: 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; Other Name: General core strengthening

Outcome Measures

Primary Outcome Measures :

1. Leg Length Inequality [ Time Frame: change from baseline at 6 weeks later ]
   functional leg length inequality
2. Ilium Anterior Tilt Difference [ Time Frame: change from baseline at 6 weeks later ]
   bilateral ilium anterior tilt difference
3. Pelvic Inclination [ Time Frame: change from baseline at 6 weeks later ]
   bilateral pelvic inclination

Secondary Outcome Measures :

1. Pain Intensity [ Time Frame: change from baseline at 6 weeks later ]
   Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome
2. Functional Disability [ Time Frame: change from baseline at 6 weeks later ]
   Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome
3. Functional Ability [ Time Frame: change from baseline at 6 weeks later ]
   PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Taiwan

National Yang Ming University

Taipei, Taiwan, 11221

Sponsors and Collaborators

National Yang Ming University

Investigators

• Study Director: Yi-Fen Shih, PhD; Department of Physical Therapy and Assistive Technology, National Yang-Ming University

  Study Documents (Full-Text)

Documents provided by Yi-Fen Shih, National Yang Ming University:

Study Protocol and Statistical Analysis Plan  [PDF] May 30, 2018

More Information

• Responsible Party: Yi-Fen Shih, Professor, Department of Physical Therapy and Assistive Technology, National Yang-Ming University, National Yang Ming University
• ClinicalTrials.gov Identifier: NCT03554746
• Other Study ID Numbers: YM106055F
• First Posted: June 13, 2018
• Results First Posted: September 19, 2019
• Last Update Posted: September 19, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leg Length Inequality; Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical