Low Back PainNCT06395493
A 12-week Pilates Programme for Low Back Pain: Perceived and Actual Outcomes
A study testing Pilates Group and Exercise Group in people with Low Back Pain, run by University of Malta.
Trial summary
Pilates has emerged as a prominent exercise therapy gaining recognition among healthcare professionals for its potential benefits in managing low back pain (LBP). As healthcare practitioners increasingly incorporate Pilates into clinical practice, understanding its effects on LBP becomes crucial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates Group and Exercise Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Aug 2025
- 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
- Participants between the age of 18-65
- Participants who have been experiencing LBP for more than 3 months
- Participants who have not undergone surgical intervention for their back in the past 6 months
- Participants who were willing to attend the Pilates programme twice a week for 12 consecutive weeks.
Who cannot join
- Pregnant women
- Participants who had undergone spinal surgery
- Participants who complained of neurological symptoms, such as parasthesia in lower limbs
- Participants who suffered from severe controlled hypertension
- Participants who were involved in other exercise, such as Pilates
- Participants who were not willing/unable to commit to attending the Pilates sessions for the duration of study.
Trial locations and contacts
No sites are listed yet.
About this study
Pilates has emerged as a prominent exercise therapy gaining recognition among healthcare professionals for its potential benefits in managing low back pain (LBP). As healthcare practitioners increasingly incorporate Pilates into clinical practice, understanding its effects on LBP becomes crucial. This study explores the rationale behind Pilates as a therapeutic intervention for LBP, its diverse applications, varying programme durations, and the significance of long-term follow-ups. Through an examination of existing studies, the aim is to unravel the nuanced impact of Pilates on pain intensity, functional disability, and overall quality of life for individuals experiencing LBP. Furthermore, this study addresses gaps in current research, guiding the way for an extended exploration into the ideal duration of Pilates programmes and the implications of sustained, long-term engagement.
Throughout this research study, the following research question was adopted: What is the perception and actual outcomes of a Pilates programme in the management of LBP in the short and long term?
The null hypothesis (H0) for this study was that there is no significant difference following a 12 weeks Pilates programme in all outcome measures. The alternative hypothesis (H1) stated that there is significant difference in outcomes following a 12-week Pilates programme in the management of LBP.
Read the detailed description
The study will investigate a longitudinal, observational three armed, interventions about the effectiveness of the 12-week pilates programme. The study will be divided in 2 phases. The first phase will seek the perception of people on Pilates in the treatment of LBP using the self-designed Questionnaire 1. The first part of the questionnaire will inquire about their experience with LBP, while the second part will involve questions regarding Pilates as a therapeutic approach.
For the first phase of the study, a minimum number of 140 participants will take part in the study. This was calculated on a total sample of 1052 patients referred for physiotherapy treatment with LBP in the year 2022. A physiotherapist from the Physiotherapy Department at the rehabilitation hospital in-charge of the back clinic shall act as an intermediary. The intermediary will contact the participants in order to deliver Questionnaire 1 either via email or postal mail before the start of any physiotherapy intervention. The questionnaires will be returned to the intermediary based on how they were originally sent, either via email or postal mail, according to the participant's choice. These questionnaire will then be passed on to the researcher for analysis. To ensure participant anonymity, the questionnaires will be coded. The intermediary will be responsible for securely managing and retaining the assigned codes.
The second phase of the study will be the intervention part. A total of 90 participants, who have completed the first phase of the study, will be randomly assigned by an intermediary, who is a physiotherapist, in change of the back clinic at the Physiotherapy Department at St Lukes' Hospital, by using a computer random generator. Simple randomization will be carried out to randomly allow each participant to either one of the 3 groups, that is the Pilates, Exercise or Control group using a computer random generator. This will ensure equal probability of assigning the participants to any group.
Prior to the Pilates intervention, all participants will be screened by the following 4 outcome measures: Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale (QBPDS), RAND 36-Item Health Survey and Hospital Anxiety and Depression Scale (HADS). All outcome measures will be assessed at baseline, 4-weeks, 8-weeks, 12-weeks and then again at 24 weeks and 52-weeks post the intervention. To mitigate participant attrition rates, particularly after completing the 12-weeks programme when clinic attendance may become challenging, all outcome measures will be conducted via telephone interviews.
In the second phase of the study, the Pilates intervention group will consist of a twice weekly sessions for a duration of 1 hour each for a period of 12 weeks. These sessions will be conducted at the Physiotherapy Department at St Luke's Hospital and the physiotherapist, who is the main researcher will be leading the Pilates sessions. The exercise group will also receive a twice weekly session, each lasting 1 hour for a duration of 12 weeks. This group will be assigned general exercises for the low back, which will also be supervised and directed by the primary researcher. The control group, on the other hand will include patients who either opt not to do the exercises or are on the waiting list for physiotherapy treatment. However, after completing the 12 weeks of no intervention, they will be asked whether they would like to receive physiotherapy treatment.
After completing the Pilates intervention group, participants will be given Questionnaire 2 to review the perception of Pilates following the intervention. This questionnaire will specifically address Pilates as a treatment method. By comparing the responses from Questionnaire 1 with the feedback obtained from Questionnaire 2, this study aim to assess the alignment between participants' perceptions of Pilates and their actual experiences following the intervention. The questionnaires will be distributed and collected by hand by the intermediary on the last day of intervention.
Both questionnaires will be coded in order to ensure the participants' anonymity and the intermediary will be responsible for securely managing and retaining the assigned codes.
- Conditions
- Low Back Pain
- Being tested
- Pilates Group, Exercise Group, Control Group
- Keywords
- Pilates, Exercise, Low Back Pain, Duration, Quality of Life, Disability, Anxiety
- Medical subject headings
- Low Back Pain, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates GroupProcedure or surgery
In this study, the participants in the Pilates group will undergo 2 sessions per week, for 12 consecutive weeks.
Exercise GroupProcedure or surgery
In this study, the participants in the Exercise group will undergo 2 sessions per week, for 12 consecutive weeks.
Control GroupProcedure or surgery
The participants in the control group, are those who either opt not to do the exercises or are on the waiting list for physiotherapy intervention. Therefore, they will not undergo any intervention for 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Intervention Group | Experimental | The Pilates intervention group will consist of a twice weekly sessions for a duration of 1 hour each for a period of 12 weeks. These sessions will be conducted at the Physiotherapy Department at St Luke's Hospital and the physiotherapist, who is the main researcher will be leading the Pilates sessions. Receives: Procedure: Pilates Group |
| Exercise Intervention Group | Experimental | The exercise group will also receive a twice weekly session, each lasting 1 hour for a duration of 12 weeks. This group will be assigned general exercises for the low back, which will also be supervised and directed by the primary researcher. Receives: Procedure: Exercise Group |
| Control Group | Experimental | The control group, on the other hand will include patients who either opt not to do the exercises or are on the waiting list for physiotherapy treatment. However, after completing the 12 weeks of no intervention, they will be asked whether they would like to receive physiotherapy treatment. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire 1
The perception of Pilates as a treatment in the management of Low Back Pain.
Measured: To be distributed to patients prior to an intervention.
Questionnaire 2
Post Pilates programme feedback questionnaire.
Measured: To be given immediately after completing the intervention programme.
Secondary outcomes (4)
Numerical Pain Rating Scale
It is a self-reported measure where individuals are asked to rate their pain on a numerical scale. Zero means 'no pain' and 10 means 'the worst possible pain'.
Measured: Up to 1 year since start of the intervention.
Quebec Back Pain Disability Scale
It is a tool designed to assess the impact of chronic pain on daily functioning and activities, particularly focusing on disability associated with pain conditions. The score disability level range from: 0 - 4 No disability, 5 - 14 Mild disability, 15 - 24 Moderate disability, 25 - 34 Severe disability and 35 - 50 Completely disabled.
Measured: Up to 1 year since start of the intervention.
RAND 36-Item Health Survey
It is a widely used health survey measuring various aspects of physical and mental well-being to assess an individual's health-related quality of life. Possible scores range from 0 to 100, with higher scores representing better health status.
Measured: Up to 1 year since start of the intervention.
Hospital Anxiety and Depression Scale
It is a self-assessment tool used to measure anxiety and depression levels in patients within a medical care setting. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.
Measured: Up to 1 year since start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janette Falzon, University of Malta
- Investigators
- Mr Tonio Agius, Principal investigator, Principal SupervisorAnabel Sciriha, Principal investigator, Co-supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395493
- Sponsor's protocol ID
- FHS-2023-00546
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Pilates Programme for Low Back Pain: Perceived and Actual Outcomes
- ClinicalTrials.gov ID
- NCT06395493
- Acronym / sponsor ID
- FHS-2023-00546
- Conditions
- Low Back Pain
- Keywords
- Pilates, Exercise, Low Back Pain, Duration, Quality of Life, Disability, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 May 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.
Pilates has emerged as a prominent exercise therapy gaining recognition among healthcare professionals for its potential benefits in managing low back pain (LBP). As healthcare practitioners increasingly incorporate Pilates into clinical practice, understanding its effects on LBP becomes crucial. This study explores the rationale behind Pilates as a therapeutic intervention for LBP, its diverse applications, varying programme durations, and the significance of long-term follow-ups. Through an examination of existing studies, the aim is to unravel the nuanced impact of Pilates on pain intensity, functional disability, and overall quality of life for individuals experiencing LBP. Furthermore, this study addresses gaps in current research, guiding the way for an extended exploration into the ideal duration of Pilates programmes and the implications of sustained, long-term engagement.
Throughout this research study, the following research question was adopted: What is the perception and actual outcomes of a Pilates programme in the management of LBP in the short and long term?
The null hypothesis (H0) for this study was that there is no significant difference following a 12 weeks Pilates programme in all outcome measures. The alternative hypothesis (H1) stated that there is significant difference in outcomes following a 12-week Pilates programme in the management of LBP.
Detailed description
The study will investigate a longitudinal, observational three armed, interventions about the effectiveness of the 12-week pilates programme. The study will be divided in 2 phases. The first phase will seek the perception of people on Pilates in the treatment of LBP using the self-designed Questionnaire 1. The first part of the questionnaire will inquire about their experience with LBP, while the second part will involve questions regarding Pilates as a therapeutic approach.
For the first phase of the study, a minimum number of 140 participants will take part in the study. This was calculated on a total sample of 1052 patients referred for physiotherapy treatment with LBP in the year 2022. A physiotherapist from the Physiotherapy Department at the rehabilitation hospital in-charge of the back clinic shall act as an intermediary. The intermediary will contact the participants in order to deliver Questionnaire 1 either via email or postal mail before the start of any physiotherapy intervention. The questionnaires will be returned to the intermediary based on how they were originally sent, either via email or postal mail, according to the participant's choice. These questionnaire will then be passed on to the researcher for analysis. To ensure participant anonymity, the questionnaires will be coded. The intermediary will be responsible for securely managing and retaining the assigned codes.
The second phase of the study will be the intervention part. A total of 90 participants, who have completed the first phase of the study, will be randomly assigned by an intermediary, who is a physiotherapist, in change of the back clinic at the Physiotherapy Department at St Lukes' Hospital, by using a computer random generator. Simple randomization will be carried out to randomly allow each participant to either one of the 3 groups, that is the Pilates, Exercise or Control group using a computer random generator. This will ensure equal probability of assigning the participants to any group.
Prior to the Pilates intervention, all participants will be screened by the following 4 outcome measures: Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale (QBPDS), RAND 36-Item Health Survey and Hospital Anxiety and Depression Scale (HADS). All outcome measures will be assessed at baseline, 4-weeks, 8-weeks, 12-weeks and then again at 24 weeks and 52-weeks post the intervention. To mitigate participant attrition rates, particularly after completing the 12-weeks programme when clinic attendance may become challenging, all outcome measures will be conducted via telephone interviews.
In the second phase of the study, the Pilates intervention group will consist of a twice weekly sessions for a duration of 1 hour each for a period of 12 weeks. These sessions will be conducted at the Physiotherapy Department at St Luke's Hospital and the physiotherapist, who is the main researcher will be leading the Pilates sessions. The exercise group will also receive a twice weekly session, each lasting 1 hour for a duration of 12 weeks. This group will be assigned general exercises for the low back, which will also be supervised and directed by the primary researcher. The control group, on the other hand will include patients who either opt not to do the exercises or are on the waiting list for physiotherapy treatment. However, after completing the 12 weeks of no intervention, they will be asked whether they would like to receive physiotherapy treatment.
After completing the Pilates intervention group, participants will be given Questionnaire 2 to review the perception of Pilates following the intervention. This questionnaire will specifically address Pilates as a treatment method. By comparing the responses from Questionnaire 1 with the feedback obtained from Questionnaire 2, this study aim to assess the alignment between participants' perceptions of Pilates and their actual experiences following the intervention. The questionnaires will be distributed and collected by hand by the intermediary on the last day of intervention.
Both questionnaires will be coded in order to ensure the participants' anonymity and the intermediary will be responsible for securely managing and retaining the assigned codes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates Intervention Group | Experimental | Procedure: Pilates GroupThe Pilates intervention group will consist of a twice weekly sessions for a duration of 1 hour each for a period of 12 weeks. These sessions will be conducted at the Physiotherapy Department at St Luke's Hospital and the physiotherapist, who is the main researcher will be leading the Pilates sessions. |
| Exercise Intervention Group | Experimental | Procedure: Exercise GroupThe exercise group will also receive a twice weekly session, each lasting 1 hour for a duration of 12 weeks. This group will be assigned general exercises for the low back, which will also be supervised and directed by the primary researcher. |
| Control Group | Experimental | Procedure: Control GroupThe control group, on the other hand will include patients who either opt not to do the exercises or are on the waiting list for physiotherapy treatment. However, after completing the 12 weeks of no intervention, they will be asked whether they would like to receive physiotherapy treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants between the age of 18-65
- Participants who have been experiencing LBP for more than 3 months
- Participants who have not undergone surgical intervention for their back in the past 6 months
- Participants who were willing to attend the Pilates programme twice a week for 12 consecutive weeks.
Key exclusion criteria (6 listed)
- Pregnant women
- Participants who had undergone spinal surgery
- Participants who complained of neurological symptoms, such as parasthesia in lower limbs
- Participants who suffered from severe controlled hypertension
- Participants who were involved in other exercise, such as Pilates
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 GroupIn this study, the participants in the Pilates group will undergo 2 sessions per week, for 12 consecutive weeks. | Procedure or surgery | Pilates Intervention Group |
| Exercise GroupIn this study, the participants in the Exercise group will undergo 2 sessions per week, for 12 consecutive weeks. | Procedure or surgery | Exercise Intervention Group |
| Control GroupThe participants in the control group, are those who either opt not to do the exercises or are on the waiting list for physiotherapy intervention. Therefore, they will not undergo any intervention for 12 consecutive weeks. | Procedure or surgery | Control Group |
Primary outcome
Questionnaire 1
Time frame: To be distributed to patients prior to an intervention.
The perception of Pilates as a treatment in the management of Low Back Pain.
Questionnaire 2
Time frame: To be given immediately after completing the intervention programme.
Post Pilates programme feedback questionnaire.
4 secondary outcomes
Numerical Pain Rating Scale
Time frame: Up to 1 year since start of the intervention.
Quebec Back Pain Disability Scale
Time frame: Up to 1 year since start of the intervention.
RAND 36-Item Health Survey
Time frame: Up to 1 year since start of the intervention.
Hospital Anxiety and Depression Scale
Time frame: Up to 1 year since start of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
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.
Mr Tonio Agius principal investigator
Principal Supervisor
Anabel Sciriha principal investigator
Co-supervisor
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Group and Exercise Group in people with Low Back Pain, run by University of Malta.
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 6 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 2 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janette Falzon (79800643 ext. +356, janette.falzon.14@um.edu.mt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire 1 (time frame: To be distributed to patients prior to an intervention.). 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 2 May 2024.