Back PainPilatesBackNCT03609554
Improvements in Adolescents With Back Pain After Pilates
A study testing Pilates in people with Back Pain, run by Universidad Católica San Antonio de Murcia.
Trial summary
The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2016to 2 Mar 2017
- 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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- having had a history of back pain last year
- being physically active in school physical education sessions
Who cannot join
- presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
- missing more than one session of the programme (91.66% attendance)
About this study
Official title: Improvement in Adolescents With a History of Back Pain After Pilates
The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain. The objective of this study is to determine whether Pilates is effective for improving the trunk endurance and hamstring extensibility of adolescents with a history of back pain and to determine the differences between the sexes. The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26). The Pilates programme was conducted over 6 weeks. For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.
Read the detailed description
Back pain during the adolescent years is a precursor to chronic back pain in adulthood. The prevalence of back pain among schoolchildren is growing across the world, and it is similar to that of the adult population. Back pain is the first cause of disability in the world.
The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain.
The objectives of this study was: a) to analyse the effect of a Pilates programme on trunk endurance and extensibility in adolescents with a history of back pain and b) to determine the differences between the sexes.
The present research was a 6-week randomised controlled trial in which adolescents with a history of back pain were randomly assigned to a Pilates-based exercise group (PEG; n = 26) and a control group (CG; n = 26).
The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26).
The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.
The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually.
For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.
- Conditions
- Back Pain
- Being tested
- Pilates
- Keywords
- trunk flexor endurance, trunk extensor endurance, hamstring extensibility
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually. The sessions were divided into the warm-up (7 min), the main part (41 min), and the cool down (7 min). Tt concentrated on basic Pilates exercises involving the principal regions of the body (spine flexions, extensions and rotations; hip flexions, extensions and rotations; and shoulder abductions, adductions and rotations).
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). Receives: Other: Pilates |
| Control | No intervention | Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk flexor endurance
The bench trunk curl (BTC) test was used to evaluate trunk flexor endurance. The result is register in repetitions numbers. Higher values represent a better outcome.
Measured: Pre and Post-intervention: change after 6 weeks of intervention
Isometric trunk extension
Isometric trunk extension endurance was measured using the Sorensen (SOR) test. The result is register in seconds. Higher values represent a better outcome.
Measured: Pre and Post-intervention: change after 6 weeks of intervention
Hamstring extensibility
The toe touch (TT) test was used to evaluate hamstring extensibility. The result is register in centimeters. Higher values represent a better outcome.
Measured: Pre and Post-intervention: change after 6 weeks of intervention
Secondary outcomes (2)
Weight
Weight was measured using a SECA 762 scale (SECA, Germany) in kilograms.
Measured: Pre and Post-intervention: change after 6 weeks of intervention
Height
Height was measured using a GPM anthropometer (Siber-Hegner, Switzerland) in meters.
Measured: Pre and Post-intervention: change after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start16 Jan 2016
- Primary completion28 Feb 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
- Investigators
- Noelia González, PhD., Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609554
- Sponsor's protocol ID
- NGonzalez-Galvez
- Acronym
- PilatesBack
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peterson L, Haladay DE. Pilates-based exercise in the treatment of a patient with persistent low back pain following transforaminal lumbar interbody fusion. Physiother Theory Pract. 2020 Apr;36(4):542-549. doi: 10.1080/09593985.2018.1488905. Epub 2018 Jun 26.
PubMed 29944036Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
PubMed 29651872Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.
PubMed 29525763Vaquero-Cristobal R, Lopez-Minarro PA, Alacid Carceles F, Esparza-Ros F. [THE EFFECTS OF THE PILATES METHOD ON HAMSTRING EXTENSIBILITY, PELVIC TILT AND TRUNK FLEXION]. Nutr Hosp. 2015 Nov 1;32(5):1967-86. doi: 10.3305/nh.2015.32.5.9678. Spanish.
PubMed 26545650Kibar S, Yardimci FO, Evcik D, Ay S, Alhan A, Manco M, Ergin ES. Can a pilates exercise program be effective on balance, flexibility and muscle endurance? A randomized controlled trial. J Sports Med Phys Fitness. 2016 Oct;56(10):1139-1146. Epub 2015 Oct 16.
PubMed 26473443Miranda IF, Souza C, Schneider AT, Chagas LC, Loss JF. Comparison of low back mobility and stability exercises from Pilates in non-specific low back pain: A study protocol of a randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:360-368. doi: 10.1016/j.ctcp.2017.12.005. Epub 2017 Dec 8.
PubMed 29248397
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Adolescents With a History of Back Pain After Pilates
- ClinicalTrials.gov ID
- NCT03609554
- Acronym / sponsor ID
- PilatesBack / NGonzalez-Galvez
- Conditions
- Back Pain
- Keywords
- trunk flexor endurance, trunk extensor endurance, hamstring extensibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 16 Jan 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 1 Aug 2018 (actual)
- 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.
The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain. The objective of this study is to determine whether Pilates is effective for improving the trunk endurance and hamstring extensibility of adolescents with a history of back pain and to determine the differences between the sexes. The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26). The Pilates programme was conducted over 6 weeks. For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.
Detailed description
Back pain during the adolescent years is a precursor to chronic back pain in adulthood. The prevalence of back pain among schoolchildren is growing across the world, and it is similar to that of the adult population. Back pain is the first cause of disability in the world.
The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain.
The objectives of this study was: a) to analyse the effect of a Pilates programme on trunk endurance and extensibility in adolescents with a history of back pain and b) to determine the differences between the sexes.
The present research was a 6-week randomised controlled trial in which adolescents with a history of back pain were randomly assigned to a Pilates-based exercise group (PEG; n = 26) and a control group (CG; n = 26).
The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26).
The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.
The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually.
For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: PilatesThe Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). |
| Control | No intervention | –Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- having had a history of back pain last year
- being physically active in school physical education sessions
Key exclusion criteria (2 listed)
- presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
- missing more than one session of the programme (91.66% attendance)
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 |
|---|---|---|
| PilatesThe Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually. The sessions were divided into the warm-up (7 min), the main part (41 min), and the cool down (7 min). Tt concentrated on basic Pilates exercises involving the principal regions of the body (spine flexions, extensions and rotations; hip flexions, extensions and rotations; and shoulder abductions, adductions and rotations). | Other | Pilates |
Primary outcome
Trunk flexor endurance
Time frame: Pre and Post-intervention: change after 6 weeks of intervention
The bench trunk curl (BTC) test was used to evaluate trunk flexor endurance. The result is register in repetitions numbers. Higher values represent a better outcome.
Isometric trunk extension
Time frame: Pre and Post-intervention: change after 6 weeks of intervention
Isometric trunk extension endurance was measured using the Sorensen (SOR) test. The result is register in seconds. Higher values represent a better outcome.
Hamstring extensibility
Time frame: Pre and Post-intervention: change after 6 weeks of intervention
The toe touch (TT) test was used to evaluate hamstring extensibility. The result is register in centimeters. Higher values represent a better outcome.
2 secondary outcomes
Weight
Time frame: Pre and Post-intervention: change after 6 weeks of intervention
Height
Time frame: Pre and Post-intervention: change after 6 weeks of intervention
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 Aug 2018.
- Background: PubMed 29944036Peterson L, Haladay DE. Pilates-based exercise in the treatment of a patient with persistent low back pain following transforaminal lumbar interbody fusion. Physiother Theory Pract. 2020 Apr;36(4):542-549. doi: 10.1080/09593985.2018.1488905. Epub 2018 Jun 26.
- Background: PubMed 29651872Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
- Background: PubMed 29525763Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.
- Background: PubMed 26545650Vaquero-Cristobal R, Lopez-Minarro PA, Alacid Carceles F, Esparza-Ros F. [THE EFFECTS OF THE PILATES METHOD ON HAMSTRING EXTENSIBILITY, PELVIC TILT AND TRUNK FLEXION]. Nutr Hosp. 2015 Nov 1;32(5):1967-86. doi: 10.3305/nh.2015.32.5.9678. Spanish.
- Background: PubMed 26473443Kibar S, Yardimci FO, Evcik D, Ay S, Alhan A, Manco M, Ergin ES. Can a pilates exercise program be effective on balance, flexibility and muscle endurance? A randomized controlled trial. J Sports Med Phys Fitness. 2016 Oct;56(10):1139-1146. Epub 2015 Oct 16.
- Background: PubMed 29248397Miranda IF, Souza C, Schneider AT, Chagas LC, Loss JF. Comparison of low back mobility and stability exercises from Pilates in non-specific low back pain: A study protocol of a randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:360-368. doi: 10.1016/j.ctcp.2017.12.005. Epub 2017 Dec 8.
- Individual participant dataSharing planned: No
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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.
Noelia González, PhD. principal investigator
UCAM
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Back Pain, run by Universidad Católica San Antonio de Murcia.
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 2 inclusion and 2 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Trunk flexor endurance (time frame: Pre and Post-intervention: change after 6 weeks of intervention). 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?
On the ClinicalTrials.gov record for NCT03609554, which also lists 6 linked publications.
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 Aug 2018.