Low Back PainPIlatesujaNCT06340191
Cueing and Pilates in Low Back Pain
A study testing Pilates with cueing and Pilates without cueing in people with Low Back Pain and Pilates Exercise, run by University of Jaén at 1 site in Spain.
Trial summary
The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Pilates Exercise, Pilates, Core Stability
- What is being tested?
- Pilates with cueing and Pilates without cueing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2023to 26 Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 to 65 years.
- Experiencing chronic non-specific low back pain for a minimum of 3 months.
- Ability to participate in supervised exercise programs.
- Absence of medical contraindications for Pilates practice.
Who cannot join
- Vestibular disorders.
- Severe osteoporosis.
- Usual Pilates practitioner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Pilates Cueing in Participants With Low Back Pain.
The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component.
Read the detailed description
The study involved two distinct groups, both of which engaged in Pilates sessions lasting for 60 minutes, held twice a week over eight weeks. These sessions were meticulously overseen by certified Pilates instructors, who brought to the table a wealth of experience. The regimen for the Pilates program was comprehensive, incorporating a blend of exercises performed on mats and with the aid of various props.
The first group, Pilates with cueing, consisted of participants who, before starting the main Pilates sessions, were given additional training. This preliminary phase involved two smaller group sessions where the focus was on learning explicit verbal and tactile cueing. These cues were specifically designed to aid participants in maintaining proper body alignment, engaging the correct muscle groups effectively, and refining their overall movement technique. Throughout the Pilates sessions, instructors provided real-time feedback, aiming to optimize the execution of exercises based on these cues.
The second group, known as Pilates without cueing, participated in an identical Pilates program to that of the first group in terms of the exercises performed, the duration of sessions, and the overall timeframe. However, this group did not receive the preliminary cueing instruction. They performed the Pilates exercises following the same program as the first group but without the added focus on cueing for alignment, muscle engagement, and technique refinement.
- Being tested
- Pilates with cueing, Pilates without cueing
- Keywords
- pilates, low back pain, mind-body
- 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 with cueingOther
The Pilates with a cueing component of the intervention involved a specialized approach to Pilates training. Participants in this group underwent an initial phase of training before the main sessions began, which consisted of two smaller group sessions focused on learning explicit verbal and tactile cues. These cues were designed to assist participants in maintaining proper body alignment, engaging specific muscle groups more effectively, and refining their movement techniques to enhance the overall efficacy of the Pilates exercises.
During the actual Pilates sessions, the instructors, who were certified and brought extensive experience to the program, provided real-time feedback to the participants. This feedback was based on the cueing instructions, aiming to optimize the execution of the Pilates exercises.
Pilates without cueingOther
The Pilates without cueing portion of the study involved participants following the same comprehensive Pilates program as the Pilates with cueing group, with a significant distinction: they did not receive any additional training on cueing. This group engaged in 60-minute Pilates sessions twice a week for 8 weeks, under the supervision of certified and highly experienced Pilates instructors. The program included a variety of exercises, both mat-based and utilizing props, designed to improve participants\' physical condition and wellness.
However, unlike their counterparts in the first group, these participants were not given explicit instructions on how to enhance their body alignment, muscle engagement, or movement techniques through verbal and tactile cues. They performed the Pilates exercises following the standard regimen, without the nuanced guidance and real-time feedback focused on optimizing exercise execution through cueing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pilates in addition to cueing Receives: Other: Pilates with cueing |
| Control group | Active comparator | Pilates without cueing Receives: Other: Pilates without cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Roland Morris Disability Questionnaire (RMDQ): The RMDQ is a self-reported measure widely used to assess physical disability due to lower back pain. It consists of 24 items that reflect the range of activities that might be affected by back pain. The scoring is simple, with higher scores indicating greater disability. This questionnaire is known for its reliability and validity in measuring disability levels in individuals with back pain
Measured: From baseline to 8 weeks
Pain report
Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.
Measured: From baseline to 8 weeks
Secondary outcomes (5)
Fear of movement
The Tampa Scale of Kinesiophobia (TSK) serves as a pivotal tool in assessing the fear of movement or re-injury, particularly among individuals with musculoskeletal pain. It quantifies kinesiophobia (the excessive, irrational fear of physical activity due to apprehensions about pain or further injury) through a questionnaire where respondents rate their agreement with various statements related to movement and pain. This scale is instrumental in identifying psychological barriers to physical activity, enabling healthcare professionals to develop more comprehensive and effective rehabilitation strategies that address both the physical and psychological facets of recovery.
Measured: From baseline to 8 weeks
Perceived Stress Scale
The Perceived Stress Scale (PSS) assesses stress perception over the past month, using a Likert scale in its questions. Scores range from 0 to 40, with higher scores indicating greater perceived stress. It's widely utilized in health research to gauge and manage stress levels.
Measured: From baseline to 8 weeks
Pain self-efficacy
The Pain Self-Efficacy Questionnaire (PSEQ) measures an individual's confidence in performing daily activities despite chronic pain, using a scale from 0 to 60, where higher scores signify greater self-efficacy.
Measured: From baseline to 8 weeks
Patient Impression of Change
The Patient Global Impression of Change (PGIC) is a one-item questionnaire that captures a patient's overall perception of change in their condition following treatment, using a 7-point Likert scale from "Very much improved" (1) to "Very much worse" (7). This tool is essential in clinical research for providing a direct, patient-reported outcome measure that reflects the subjective efficacy and impact of interventions. Its simplicity and adaptability across various medical conditions make it a valuable instrument for evaluating patient-centered treatment outcomes.
Measured: From baseline to 8 weeks
Body Awareness
The Body Awareness Questionnaire (BAQ) is a self-report measure designed to assess an individual's attentiveness to internal bodily sensations, encompassing aspects such as recognizing hunger and satiety signals, breathing patterns, and muscle tension. It typically employs a Likert scale for responses, allowing participants to rate their level of agreement with various statements. The BAQ's scoring system is used to quantify the degree of body awareness, with higher scores indicating greater awareness. This tool is valuable in research and clinical settings, particularly in studies of mind-body interventions, psychological well-being, and somatic disorders.
Measured: From baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start2 May 2023
- Primary completion20 Feb 2024
- Study completion26 Feb 2024
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.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- DAVID CRUZ DIAZ, PhD, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340191
- Sponsor's protocol ID
- UJAPIlates1
- Acronym
- PIlatesuja
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pilates Cueing in Participants With Low Back Pain.
- ClinicalTrials.gov ID
- NCT06340191
- Acronym / sponsor ID
- PIlatesuja / UJAPIlates1
- Keywords
- pilates, low back pain, mind-body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 1 Apr 2024 (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 intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component.
Detailed description
The study involved two distinct groups, both of which engaged in Pilates sessions lasting for 60 minutes, held twice a week over eight weeks. These sessions were meticulously overseen by certified Pilates instructors, who brought to the table a wealth of experience. The regimen for the Pilates program was comprehensive, incorporating a blend of exercises performed on mats and with the aid of various props.
The first group, Pilates with cueing, consisted of participants who, before starting the main Pilates sessions, were given additional training. This preliminary phase involved two smaller group sessions where the focus was on learning explicit verbal and tactile cueing. These cues were specifically designed to aid participants in maintaining proper body alignment, engaging the correct muscle groups effectively, and refining their overall movement technique. Throughout the Pilates sessions, instructors provided real-time feedback, aiming to optimize the execution of exercises based on these cues.
The second group, known as Pilates without cueing, participated in an identical Pilates program to that of the first group in terms of the exercises performed, the duration of sessions, and the overall timeframe. However, this group did not receive the preliminary cueing instruction. They performed the Pilates exercises following the same program as the first group but without the added focus on cueing for alignment, muscle engagement, and technique refinement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pilates with cueingPilates in addition to cueing |
| Control group | Active comparator | Other: Pilates without cueingPilates without cueing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 to 65 years.
- Experiencing chronic non-specific low back pain for a minimum of 3 months.
- Ability to participate in supervised exercise programs.
- Absence of medical contraindications for Pilates practice.
Key exclusion criteria (3 listed)
- Vestibular disorders.
- Severe osteoporosis.
- Usual Pilates practitioner.
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 with cueingThe Pilates with a cueing component of the intervention involved a specialized approach to Pilates training. Participants in this group underwent an initial phase of training before the main sessions began, which consisted of two smaller group sessions focused on learning explicit verbal and tactile cues. These cues were designed to assist participants in maintaining proper body alignment, engaging specific muscle groups more effectively, and refining their movement techniques to enhance the overall efficacy of the Pilates exercises. During the actual Pilates sessions, the instructors, who were certified and brought extensive experience to the program, provided real-time feedback to the participants. This feedback was based on the cueing instructions, aiming to optimize the execution of the Pilates exercises. | Other | Intervention group |
| Pilates without cueingThe Pilates without cueing portion of the study involved participants following the same comprehensive Pilates program as the Pilates with cueing group, with a significant distinction: they did not receive any additional training on cueing. This group engaged in 60-minute Pilates sessions twice a week for 8 weeks, under the supervision of certified and highly experienced Pilates instructors. The program included a variety of exercises, both mat-based and utilizing props, designed to improve participants\' physical condition and wellness. However, unlike their counterparts in the first group, these participants were not given explicit instructions on how to enhance their body alignment, muscle engagement, or movement techniques through verbal and tactile cues. They performed the Pilates exercises following the standard regimen, without the nuanced guidance and real-time feedback focused on optimizing exercise execution through cueing. | Other | Control group |
Primary outcome
Low back pain
Time frame: From baseline to 8 weeks
Roland Morris Disability Questionnaire (RMDQ): The RMDQ is a self-reported measure widely used to assess physical disability due to lower back pain. It consists of 24 items that reflect the range of activities that might be affected by back pain. The scoring is simple, with higher scores indicating greater disability. This questionnaire is known for its reliability and validity in measuring disability levels in individuals with back pain
Pain report
Time frame: From baseline to 8 weeks
Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.
5 secondary outcomes
Fear of movement
Time frame: From baseline to 8 weeks
Perceived Stress Scale
Time frame: From baseline to 8 weeks
Pain self-efficacy
Time frame: From baseline to 8 weeks
Patient Impression of Change
Time frame: From baseline to 8 weeks
Body Awareness
Time frame: From baseline to 8 weeks
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 Apr 2024.
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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.
DAVID CRUZ DIAZ, PhD principal investigator
University of Jaén
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 with cueing and Pilates without cueing in people with Low Back Pain and Pilates Exercise, run by University of Jaén at 1 site in Spain.
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 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 Apr 2024. 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 Spain. 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?
Low back pain (time frame: From baseline to 8 weeks). 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 1 Apr 2024.