Low Back Pain, RecurrentNCT03554746
Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality
A study testing GC group and CG group in people with Low Back Pain, Recurrent, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- GC group and CG group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Dec 2017to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality: A Ramdomized Controlled Trail
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.
Read the 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.
- Conditions
- Low Back Pain, Recurrent
- Being tested
- GC group, CG group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC groupOther
Also called Additional gluteal muscle control training
- 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 groupOther
Also called General core strengthening
- 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
| Study group | Role | What they receive |
|---|---|---|
| GC group | Experimental | 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. Receives: Other: GC group |
| CG group | Experimental | It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. Receives: Other: CG group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Length Inequality
functional leg length inequality
Measured: change from baseline at 6 weeks later
Ilium Anterior Tilt Difference
bilateral ilium anterior tilt difference
Measured: change from baseline at 6 weeks later
Pelvic Inclination
bilateral pelvic inclination
Measured: change from baseline at 6 weeks later
Secondary outcomes (3)
Pain Intensity
Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome
Measured: change from baseline at 6 weeks later
Functional Disability
Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome
Measured: change from baseline at 6 weeks later
Functional Ability
PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome
Measured: change from baseline at 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start11 Dec 2017
- Primary completion23 Jul 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, PhD, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554746
- Sponsor's protocol ID
- YM106055F
- Status last verified
- Aug 2019
- First submitted
- 30 May 2018
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality: A Ramdomized Controlled Trail
- ClinicalTrials.gov ID
- NCT03554746
- Acronym / sponsor ID
- YM106055F
- Conditions
- Low Back Pain, Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC group | Experimental | Other: GC groupIt 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. |
| CG group | Experimental | Other: CG groupIt involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC groupAlso: Additional gluteal muscle control training1. 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 1. Hamstring 2. 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: <!-- --> 1. maintain 3rd to 4th ex. 2. single leg standing on rock board to maintain balance 6th: <!-- --> 1. maintain 5th ex. 2. lunge ex. without hip internal rotation | Other | GC group |
| CG groupAlso: General core strengthening1. 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 1. Hamstring 2. Quadriceps | Other | CG group |
Primary outcome
Leg Length Inequality
Time frame: change from baseline at 6 weeks later
functional leg length inequality
Ilium Anterior Tilt Difference
Time frame: change from baseline at 6 weeks later
bilateral ilium anterior tilt difference
Pelvic Inclination
Time frame: change from baseline at 6 weeks later
bilateral pelvic inclination
3 secondary outcomes
Pain Intensity
Time frame: change from baseline at 6 weeks later
Functional Disability
Time frame: change from baseline at 6 weeks later
Functional Ability
Time frame: change from baseline at 6 weeks later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Fen Shih, PhD study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GC group and CG group in people with Low Back Pain, Recurrent, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Length Inequality (time frame: change from baseline at 6 weeks later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.