Adolescent Idiopathic ScoliosisLBPAISNCT01550497
Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
A study testing supervised spinal stabilization exercises in people with Adolescent Idiopathic Scoliosis and Low Back Pain, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
1. Do spinal stabilization exercises demonstrate immediate and long-term effects of weight weeks of spinal stabilization exercises as measured by pain intensity and quality of life scores? 2. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Low Back Pain
- What is being tested?
- supervised spinal stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 31 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents (ages 10-17),
- Idiopathic Scoliosis,
- Low Back Pain (> 2/10 on Numeric Pain Rating Scale)
Who cannot join
- other pathology of lumbar spine (like spondylotic lesion),
- current treatment (like bracing and chiropractic care),
- back pain located beyond the lumbar spine
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
About this study
Official title: Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
- Do spinal stabilization exercises demonstrate immediate and long-term effects of weight weeks of spinal stabilization exercises as measured by pain intensity and quality of life scores?
- Does eight weeks of spinal stabilization exercises improve back muscle endurance in adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a one-time treatment (control)?
Hypotheses:
Read more
The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal stabilization exercises will demonstrate significantly improved pain intensity and quality of life scores compared to participants who receive a one-time treatment after eight weeks of the intervention period and at six-month follow-up.
The research hypothesis for Question 2 is: Participants who receive eight weeks of the spinal stabilization exercises will demonstrate significantly improved back muscle endurance, compared to participants who receive a one-time treatment after eight weeks of intervention.
Read the detailed description
Although idiopathic scoliosis (IS) is the most common type of scoliosis, no studies have evaluated the effectiveness of physical therapy exercises for managing low back pain (LBP) in this population. Spinal stabilization exercises are of particular importance in adolescents with IS due to possible reduced spinal stability from structural deformity. Spinal stabilization exercises have been reported to prevent recurrent episodes of LBP in the adult population. However, standardized treatment options cannot be recommended for LBP in adolescents with IS, because the investigators are not certain if spinal stabilization exercises will have the same effect on this patient population. Given the high prevalence of LBP in AIS and limited evidence of conservative interventions, researching the effectiveness of spinal stabilization exercises is warranted.
Currently, there are two common practices for managing adolescents with IS who have LBP: 1) supervised physical therapy and 2) a one-time treatment with no follow-up. No studies have examined which of these two approaches is superior. This study will provide information on optimal management of LBP in AIS. If there is no difference in outcomes between these two approaches, a one-time visit will be the optimal choice of treatment since it is more cost-effective and less burdensome for the family. If the outcomes favor the eight-week supervised physical therapy, specifically the spinal stabilization exercises, this treatment approach should be recommended for managing LBP in AIS.
- Conditions
- Adolescent Idiopathic Scoliosis, Low Back Pain
- Being tested
- supervised spinal stabilization exercises
- Keywords
- back pain, scoliosis, home exercise program
- Medical subject headings
- Low Back Pain, Back Pain, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised spinal stabilization exercisesOther
Supervised or unsupervised exercises to be done for 20 minutes at home, at least 5 times a week for the first 2 weeks and at least 3 times a week after 2 weeks. The supervised weekly physical therapy group will complete 8 weeks of weekly physical therapy. The unsupervised home exercise group will complete 8 weeks of a prescribed home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group | Experimental | Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks Receives: Other: supervised spinal stabilization exercises |
| Weeky Physical Therapy Group | Experimental | weekly physical therapy of supervised spinal stabilization exercises for 8 weeks Receives: Other: supervised spinal stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain from initial visit
Numeric Pain Rating Scale
Measured: Initial visit 'day 1', After 8 weeks, After 6 months
Secondary outcomes (2)
Change in back muscle endurance from initial visit
Prone double leg raise
Measured: Initial visit 'day 1', After 8 weeks, After 6 months
Change in quality of life since initial visit
SRS-22
Measured: Initial visit 'day 1', After 8 weeks, After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study start1 Mar 2012
- Primary completion31 Oct 2013
- Study completion31 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association, Texas Woman's University
- Responsible party
- Principal investigator, Karina Zapata, PT, DPT, PhD, Texas Scottish Rite Hospital for Children
- Investigators
- Karina A Kunder, PT, DPT, Principal investigator, Texas Scottish Rite Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550497
- Sponsor's protocol ID
- STU 092011-073
- Acronym
- LBPAIS
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2012
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT01550497
- Acronym / sponsor ID
- LBPAIS / STU 092011-073
- Conditions
- Adolescent Idiopathic Scoliosis, Low Back Pain
- Keywords
- back pain, scoliosis, home exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Collaborators
- American Physical Therapy Association, Texas Woman's University
- Study start
- 1 Mar 2012
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 31 Oct 2013 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Do spinal stabilization exercises demonstrate immediate and long-term effects of weight weeks of spinal stabilization exercises as measured by pain intensity and quality of life scores?
- Does eight weeks of spinal stabilization exercises improve back muscle endurance in adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a one-time treatment (control)?
Hypotheses:
The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal stabilization exercises will demonstrate significantly improved pain intensity and quality of life scores compared to participants who receive a one-time treatment after eight weeks of the intervention period and at six-month follow-up.
The research hypothesis for Question 2 is: Participants who receive eight weeks of the spinal stabilization exercises will demonstrate significantly improved back muscle endurance, compared to participants who receive a one-time treatment after eight weeks of intervention.
Detailed description
Although idiopathic scoliosis (IS) is the most common type of scoliosis, no studies have evaluated the effectiveness of physical therapy exercises for managing low back pain (LBP) in this population. Spinal stabilization exercises are of particular importance in adolescents with IS due to possible reduced spinal stability from structural deformity. Spinal stabilization exercises have been reported to prevent recurrent episodes of LBP in the adult population. However, standardized treatment options cannot be recommended for LBP in adolescents with IS, because the investigators are not certain if spinal stabilization exercises will have the same effect on this patient population. Given the high prevalence of LBP in AIS and limited evidence of conservative interventions, researching the effectiveness of spinal stabilization exercises is warranted.
Currently, there are two common practices for managing adolescents with IS who have LBP: 1) supervised physical therapy and 2) a one-time treatment with no follow-up. No studies have examined which of these two approaches is superior. This study will provide information on optimal management of LBP in AIS. If there is no difference in outcomes between these two approaches, a one-time visit will be the optimal choice of treatment since it is more cost-effective and less burdensome for the family. If the outcomes favor the eight-week supervised physical therapy, specifically the spinal stabilization exercises, this treatment approach should be recommended for managing LBP in AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group | Experimental | Other: supervised spinal stabilization exercisesPerform home exercises of unsupervised spinal stabilization exercises for 8 weeks |
| Weeky Physical Therapy Group | Experimental | Other: supervised spinal stabilization exercisesweekly physical therapy of supervised spinal stabilization exercises for 8 weeks |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescents (ages 10-17),
- Idiopathic Scoliosis,
- Low Back Pain (> 2/10 on Numeric Pain Rating Scale)
Key exclusion criteria (3 listed)
- other pathology of lumbar spine (like spondylotic lesion),
- current treatment (like bracing and chiropractic care),
- back pain located beyond the lumbar spine
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 |
|---|---|---|
| supervised spinal stabilization exercisesSupervised or unsupervised exercises to be done for 20 minutes at home, at least 5 times a week for the first 2 weeks and at least 3 times a week after 2 weeks. The supervised weekly physical therapy group will complete 8 weeks of weekly physical therapy. The unsupervised home exercise group will complete 8 weeks of a prescribed home exercise program. | Other | Home Exercise Group, Weeky Physical Therapy Group |
Primary outcome
Change in pain from initial visit
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
Numeric Pain Rating Scale
2 secondary outcomes
Change in back muscle endurance from initial visit
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
Change in quality of life since initial visit
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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.
Karina A Kunder, PT, DPT principal investigator
Texas Scottish Rite Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised spinal stabilization exercises in people with Adolescent Idiopathic Scoliosis and Low Back Pain, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
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 3 inclusion and 3 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 1 Oct 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain from initial visit (time frame: Initial visit 'day 1', After 8 weeks, After 6 months). 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 1 Oct 2021.