A 12-week Pilates Programme for Low Back Pain: Perceived and Actual Outcomes

NCT06395493 | Not Yet Recruiting

• 1 other identifier: FHS-2023-00546
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Low Back Pain

Keywords

Pilates; Exercise; Low Back Pain; Duration; Quality of Life; Disability; Anxiety

Outcome Measures

Primary Outcomes (2)

• Questionnaire 1

  The perception of Pilates as a treatment in the management of Low Back Pain.

  To be distributed to patients prior to an intervention.

• Questionnaire 2

  Post Pilates programme feedback questionnaire.

  To be given immediately after completing the intervention programme.

Secondary Outcomes (4)

• Numerical Pain Rating Scale

  Up to 1 year since start of the intervention.

• Quebec Back Pain Disability Scale

  Up to 1 year since start of the intervention.

• RAND 36-Item Health Survey

  Up to 1 year since start of the intervention.

• Hospital Anxiety and Depression Scale

  Up to 1 year since start of the intervention.

Study Arms (3)

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.

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.

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.

Procedure: Control Group

Interventions

Pilates Group PROCEDURE

In this study, the participants in the Pilates group will undergo 2 sessions per week, for 12 consecutive weeks.

Pilates Intervention Group

Exercise Group PROCEDURE

In this study, the participants in the Exercise group will undergo 2 sessions per week, for 12 consecutive weeks.

Exercise Intervention Group

Control Group PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malta: lead

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mr Tonio Agius

  Principal Supervisor

  PRINCIPAL INVESTIGATOR

• Anabel Sciriha

  Co-supervisor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janette Falzon

CONTACT

79800643; janette.falzon.14@um.edu.mt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share