Trial Outcomes & Findings for Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality (NCT NCT03554746)

NCT ID: NCT03554746

Last Updated: 2019-09-19

Results Overview

functional leg length inequality

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: change from baseline at 6 weeks later
• Results posted on: 2019-09-19

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GC Group n=24 Participants 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	CG Group n=24 Participants 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	Total n=48 Participants Total of all reporting groups
Age, Continuous	47.58 years STANDARD_DEVIATION 9.42 • n=24 Participants	47.38 years STANDARD_DEVIATION 11.31 • n=24 Participants	47.48 years STANDARD_DEVIATION 10.47 • n=48 Participants
Sex: Female, Male Female	13 Participants n=24 Participants	14 Participants n=24 Participants	27 Participants n=48 Participants
Sex: Female, Male Male	11 Participants n=24 Participants	10 Participants n=24 Participants	21 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: change from baseline at 6 weeks later

functional leg length inequality

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Leg Length Inequality	0.3 centemeter Standard Deviation 0.21	0.58 centemeter Standard Deviation 0.13

PRIMARY outcome

Timeframe: change from baseline at 6 weeks later

bilateral ilium anterior tilt difference

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Ilium Anterior Tilt Difference	0.67 degrees Standard Deviation 0.65	2.27 degrees Standard Deviation 0.65

PRIMARY outcome

Timeframe: change from baseline at 6 weeks later

bilateral pelvic inclination

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Pelvic Inclination	1.03 degrees Standard Deviation 0.37	1.56 degrees Standard Deviation 0.51

SECONDARY outcome

Timeframe: change from baseline at 6 weeks later

Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Pain Intensity	1.3 score on a scale Standard Deviation 1.21	3.44 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: change from baseline at 6 weeks later

Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Functional Disability	7.51 score on a scale Standard Deviation 5.34	11.91 score on a scale Standard Deviation 6.65

SECONDARY outcome

Timeframe: change from baseline at 6 weeks later

PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome

Outcome measures

Measure	GC Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. 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: 1. clam ex. without resistance 2. 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: 1. maintain 5th ex. 2. lunge ex. without hip internal rotation	CG Group n=24 Participants 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 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times a. Hamstring b. Quadriceps
Functional Ability	8.23 score on a scale Standard Deviation 1.18	7.09 score on a scale Standard Deviation 1.28

Adverse Events

CG Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yi-Fen Shih

National Yang Ming University

Phone: +886-2-28267340

Email: yfshih@ym.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place