Effectiveness of Pilates in Patients With Subacute Low Back Pain (Pilates-SLBP)

November 20, 2024 updated by: TUĞBA ŞAHBAZ, University of Beykent

This study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Pilates is an exercise method that strengthens core muscle groups, improves flexibility, and supports body balance.

This research is designed as a comparative study between two groups. One group will participate in Pilates exercises, while the other group will follow a standard home exercise program. The study will assess outcomes such as pain level, mobility, and quality of life. Through this, the study aims to provide more insights into the potential of Pilates as a treatment method for subacute low back pain.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study investigates the role of Pilates exercises in managing subacute low back pain, a condition defined as lasting between 4 and 12 weeks. Subacute low back pain often disrupts daily functioning and lowers quality of life, and effective interventions during this stage are crucial to prevent the transition to chronic pain. Pilates has been suggested as a beneficial exercise approach due to its focus on core stability, flexibility, and balanced body mechanics, which may reduce pain and improve functional outcomes in low back pain patients.

Participants in the study will be divided into two groups: a Pilates group and a home exercise group. The Pilates group will participate in a structured Pilates program designed to target core muscle strength and flexibility over a set period, while the home exercise group will follow a standard exercise program tailored for general low back pain relief. Both groups will perform their respective exercises for eight weeks.

The primary outcome measures will include pain intensity, physical function, and quality of life, assessed at baseline, post-treatment, and follow-up periods. The findings from this study will contribute to understanding whether Pilates can be a valuable addition to conservative treatment approaches for subacute low back pain.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Büyükçekmece
      • Istanbul, Büyükçekmece, Turkey, 34500
        • Istanbul Beykent Univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged between 18 and 65 years.D
  • Diagnosis of subacute low back pain, defined as pain lasting between 6 and 12 weeks
  • No previous Pilates experience.

Exclusion Criteria:

  • History of spinal surgery or significant spinal deformities (e.g., scoliosis).
  • Presence of serious medical conditions such as cardiovascular disease, uncontrolled hypertension, or neurological disorders.
  • Pregnancy or planned pregnancy during the study period.
  • Use of pain-relief medications that could interfere with the results of the study.
  • Participation in any structured physical therapy program in the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pilates exercise
Behavioral: Exercise
Exercise
Active Comparator: Home exercis
Home exercise
Behavioral: Exercise
Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: pretreatment, post-treatment (8 weeks), and at 3-month follow-up
The Visual Analog Scale (VAS) is used to measure pain intensity. The scale ranges from 0 to 10, where 0 represents 'no pain' and 10 represents 'worst possible pain.' Higher scores indicate worse outcomes, signifying greater pain intensity
pretreatment, post-treatment (8 weeks), and at 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/2022.11.211 (Other Identifier: Kanuni Sultan Suleyman Training and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision to share IPD is currently under consideration and will depend on future funding resources and availability of data-sharing infrastructure.

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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