Lower Back PainNCT03854643
Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain
A study testing Pilates group in people with Lower Back Pain, run by Universidade Cruzeiro do Sul at 1 site in Brazil.
Trial summary
This study aims to verify the influence of the Pilates Method on the improvement of pain in patients with non-specific chronic low back pain Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Pilates group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2018to 30 Jul 2019
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Present lumbar pain of degree greater than or equal to 3;
- Present lumbar pain for twelve weeks or more;
- Present low back pain without it being related to any specific pathology or cause;
- The Volunteers may not be undergoing physiotherapeutic or drug treatment
Who cannot join
- Volunteers who present with pain grade 1 or 2 of low back pain;
- Volunteers with severe movement limitations;
- Neurological or neurological diseases that interfere with significant neuromotor
- Individuals who did not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain: Clinical Controlled, Randomized and Double Clinical Test.
This study aims to verify the influence of the Pilates Method on the improvement of pain in patients with non-specific chronic low back pain
Read the detailed description
Nonspecific low back pain is defined as localized pain and discomfort between the lower margins of the costal gradis and the lower gluteal folds. Chronic low back pain may be associated with central sensitization (CS) which is a proposed physiological phenomenon in which a deregulation in the central nervous system. Another relevant point related to worsening pain is kinesiophobia, which is fear of movement due to pain which impedes the movement or causes the person to gradually decrease their activities, thus limiting their functions, and restricting their participation in activities of daily living. The research design is a randomized, controlled, blinded clinical trial on the influence of central stabilization on the basis of the Pilates method in improving pain, kinesiophobia, central sensitization and function in patients with chronic low back pain of non-specific origin. It is a research with four evaluations: pre-treatment, post-two weeks, post four weeks and three months after the end of treatment. An evaluation form will be used, containing questions about personal data, history of diseases, ethylism, smoking, medications used and pain intensity by the numerical scale of pain. The Tampa scale for kinesiophobia will also be used. The Central Sensitization questionnaire, which has two parts, part A containing 25 questions about the presence of pain in the last 3 months and part B containing 10 questions about possible medical diagnoses will be used. Finally, the Oswestry 2.0 Disability Index will be applied. 34 (thirty-four) volunteers, of both genders, aged between 18 and 35 years old will be recruited for at least 3 (three) months of non-specific back pain; of which 17 (seventeen) will undergo the Pilates Method and 17 (seventeen) will be part of the control group. Pilates exercises will be performed three times a week for 4 weeks, totaling 12 sessions of treatment, by a researcher with training in the method and previous training in performing the exercises. The re-evaluations will be performed after the sixth treatment session (Pilates group) and two weeks after the initial evaluation (control group), after the twelfth session (Pilates group) and after four weeks for the control group. A reevaluation will also be performed after 3 months of treatment, in order to analyze how well the Pilates method was effective in maintaining the improvement of the patient's clinical condition.
- Conditions
- Lower Back Pain
- Being tested
- Pilates group, Control group
- Keywords
- pilates method
- 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.
Pilates groupOther
Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.
Control groupOther
These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | 17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. Receives: Other: Pilates group |
| Control group | Experimental | 17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower back pain
Intensity of pain through the visual analogic scale, which contains 11 points, ranging from 0 to 10, with 0 corresponding to "no pain" and 10 to unbearable pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start2 Apr 2018
- Primary completion15 Oct 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cruzeiro do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Lazzareschi, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854643
- Sponsor's protocol ID
- 90158318.3.0000.5497
- Status last verified
- Jan 2020
- First submitted
- 16 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain: Clinical Controlled, Randomized and Double Clinical Test.
- ClinicalTrials.gov ID
- NCT03854643
- Acronym / sponsor ID
- 90158318.3.0000.5497
- Conditions
- Lower Back Pain
- Keywords
- pilates method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Cruzeiro do SulUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 26 Feb 2019 (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.
This study aims to verify the influence of the Pilates Method on the improvement of pain in patients with non-specific chronic low back pain
Detailed description
Nonspecific low back pain is defined as localized pain and discomfort between the lower margins of the costal gradis and the lower gluteal folds. Chronic low back pain may be associated with central sensitization (CS) which is a proposed physiological phenomenon in which a deregulation in the central nervous system. Another relevant point related to worsening pain is kinesiophobia, which is fear of movement due to pain which impedes the movement or causes the person to gradually decrease their activities, thus limiting their functions, and restricting their participation in activities of daily living. The research design is a randomized, controlled, blinded clinical trial on the influence of central stabilization on the basis of the Pilates method in improving pain, kinesiophobia, central sensitization and function in patients with chronic low back pain of non-specific origin. It is a research with four evaluations: pre-treatment, post-two weeks, post four weeks and three months after the end of treatment. An evaluation form will be used, containing questions about personal data, history of diseases, ethylism, smoking, medications used and pain intensity by the numerical scale of pain. The Tampa scale for kinesiophobia will also be used. The Central Sensitization questionnaire, which has two parts, part A containing 25 questions about the presence of pain in the last 3 months and part B containing 10 questions about possible medical diagnoses will be used. Finally, the Oswestry 2.0 Disability Index will be applied. 34 (thirty-four) volunteers, of both genders, aged between 18 and 35 years old will be recruited for at least 3 (three) months of non-specific back pain; of which 17 (seventeen) will undergo the Pilates Method and 17 (seventeen) will be part of the control group. Pilates exercises will be performed three times a week for 4 weeks, totaling 12 sessions of treatment, by a researcher with training in the method and previous training in performing the exercises. The re-evaluations will be performed after the sixth treatment session (Pilates group) and two weeks after the initial evaluation (control group), after the twelfth session (Pilates group) and after four weeks for the control group. A reevaluation will also be performed after 3 months of treatment, in order to analyze how well the Pilates method was effective in maintaining the improvement of the patient's clinical condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Other: Pilates group17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. |
| Control group | Experimental | Other: Control group17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Present lumbar pain of degree greater than or equal to 3;
- Present lumbar pain for twelve weeks or more;
- Present low back pain without it being related to any specific pathology or cause;
- The Volunteers may not be undergoing physiotherapeutic or drug treatment
Key exclusion criteria (4 listed)
- Volunteers who present with pain grade 1 or 2 of low back pain;
- Volunteers with severe movement limitations;
- Neurological or neurological diseases that interfere with significant neuromotor
- Individuals who did not agree to participate in the study
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 groupPilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. | Other | Pilates group |
| Control groupThese patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months. | Other | Control group |
Primary outcome
lower back pain
Time frame: 3 months
Intensity of pain through the visual analogic scale, which contains 11 points, ranging from 0 to 10, with 0 corresponding to "no pain" and 10 to unbearable pain.
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 27 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Lower Back Pain, run by Universidade Cruzeiro do Sul 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 4 inclusion and 4 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 27 Jan 2020. 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?
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?
lower back pain (time frame: 3 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 27 Jan 2020.