Low Back PainNCT05047562
Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain
A study testing Pilates Group and Segmental Stabilization group in people with Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates Group and Segmental Stabilization group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jun 2019to Mar 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific low back pain for at least 3 months.
- Intensity of pain equal to or greater than 3 cm.
Who cannot join
- Specific low back pain.
- Neurological involvement (radiculopathy, myelopathy).
- Previous spinal surgery.
- Any impediment to performing the exercises.
- Having had recent surgeries.
- Being on treatment for low back pain
- Not having cognitive ability to perform the exercises or be submitted to the proposed assessments
- Missing appointments three times in a row.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo
Ariela Cruz, 5524992192494, ariela.tcruz@usp.br
About this study
Official title: Effect of Pilates Method and Segmental Stabilization in Elderly People With Chronic Non-specific Low Back Pain: Randomized Clinical Trial
INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.
- Conditions
- Low Back Pain
- Being tested
- Pilates Group, Segmental Stabilization group
- Keywords
- Chronic Pain, Exercise Therapy, Physical Therapy Modalities
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates GroupOther
16 Pilates exercise sessions twice a week for 2 months.
Segmental Stabilization groupOther
16 sessions of segmental stabilization exercises, 2 times a week for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Active comparator | Participants will undergo 16 sessions, twice a week on alternate days through the following Pilates Method exercises: Pelvic Curl, Leg lift Supine, One leg circle modified and Hundred modified. There will be 4 sets of 5 repetitions in the first week, 6 repetitions in the second week, 7 repetitions in the third week, 8 repetitions in the fourth week, 9 repetitions in the fifth week, 10 repetitions in the sixth to eighth week. Receives: Other: Pilates Group |
| Segmental Stabilization Group | Active comparator | Participants will undergo 16 consultations, twice a week on alternate days through the following Segmental Stabilization exercises: multifidus in prone position, transverse abdomen in four supports, transverse abdomen in dorsal decubitus and transverse abdomen associated with multifidus in position orthostatic. There will be 4 sets of 10 repetitions of 10 seconds in all appointments. Receives: Other: Segmental Stabilization group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment
The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient.
Change = Baseline, week 16, 3 and 6 months after the end of treatment.
Measured: Baseline, week 16, 3 and 6 months after completion of treatment.
Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.
Measured: Baseline, week 16, 3 and 6 months after completion of treatment.
Secondary outcomes (3)
Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.
The Tampa scale of kinesiophobia consists of a self-administered questionnaire consisting of 17 questions that address pain and symptom intensity. The scores range from 1 to 4, with the answer "strongly disagree" equaling 1 point, "partially disagree" with 2 points, "partially agree" with 3 points, "strongly agree" with 4 points. To obtain the final total score, it is necessary to invert the scores of questions 4, 8, 12 and 16. The final score can be a minimum of 17 and a maximum of 68 points, the higher the score, the higher the degree of kinesiophobia
Measured: Baseline, week 16, 3 and 6 months after completion of treatment.
Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.
The ABC scale - Activities-Specific Balance Confidence or Confidence in Balance for Specific Activities was developed to numerically quantify the level of confidence in carrying out specific activities without losing balance or becoming unstable. The higher the score, the greater the confidence to perform the activities.
Measured: Baseline, week 16, 3 and 6 months after completion of treatment.
Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.
The pressure biofeedback unit is a reliable instrument for the analysis of transversus abdominis muscle contraction. The lower the pressure, the greater the ability to activate this muscle.
Measured: Baseline, week 16, 3 and 6 months after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start13 Jun 2019
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariela Cruz, Principal investigator, University of Sao PauloAmelia Marques, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047562
- Sponsor's protocol ID
- 3270664
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Method and Segmental Stabilization in Elderly People With Chronic Non-specific Low Back Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05047562
- Acronym / sponsor ID
- 3270664
- Conditions
- Low Back Pain
- Keywords
- Chronic Pain, Exercise Therapy, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Sep 2021 (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.
INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Active comparator | Other: Pilates GroupParticipants will undergo 16 sessions, twice a week on alternate days through the following Pilates Method exercises: Pelvic Curl, Leg lift Supine, One leg circle modified and Hundred modified. There will be 4 sets of 5 repetitions in the first week, 6 repetitions in the second week, 7 repetitions in the third week, 8 repetitions in the fourth week, 9 repetitions in the fifth week, 10 repetitions in the sixth to eighth week. |
| Segmental Stabilization Group | Active comparator | Other: Segmental Stabilization groupParticipants will undergo 16 consultations, twice a week on alternate days through the following Segmental Stabilization exercises: multifidus in prone position, transverse abdomen in four supports, transverse abdomen in dorsal decubitus and transverse abdomen associated with multifidus in position orthostatic. There will be 4 sets of 10 repetitions of 10 seconds in all appointments. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-specific low back pain for at least 3 months.
- Intensity of pain equal to or greater than 3 cm.
Key exclusion criteria (8 listed)
- Specific low back pain.
- Neurological involvement (radiculopathy, myelopathy).
- Previous spinal surgery.
- Any impediment to performing the exercises.
- Having had recent surgeries.
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 |
|---|---|---|
| Pilates Group16 Pilates exercise sessions twice a week for 2 months. | Other | Pilates Group |
| Segmental Stabilization group16 sessions of segmental stabilization exercises, 2 times a week for 2 months. | Other | Segmental Stabilization Group |
Primary outcome
Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment
Time frame: Baseline, week 16, 3 and 6 months after completion of treatment.
The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient. Change = Baseline, week 16, 3 and 6 months after the end of treatment.
Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
Time frame: Baseline, week 16, 3 and 6 months after completion of treatment.
The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.
3 secondary outcomes
Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.
Time frame: Baseline, week 16, 3 and 6 months after completion of treatment.
Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.
Time frame: Baseline, week 16, 3 and 6 months after completion of treatment.
Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.
Time frame: Baseline, week 16, 3 and 6 months after completion of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Ariela Cruz principal investigator
University of Sao Paulo
Amelia Marques study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Group and Segmental Stabilization group in people with Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 17 Sep 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariela Cruz (5524992192494, ariela.tcruz@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment (time frame: Baseline, week 16, 3 and 6 months after completion of treatment.). The study lists 2 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 17 Sep 2021.