NCT06699511

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 18, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

PilatesSubacute low back pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    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

Study Arms (2)

pilates exercise

ACTIVE COMPARATOR

pilates exercise

Behavioral: Exercise

Home exercis

ACTIVE COMPARATOR

Home exercise

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Exercise

Home exercispilates exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Beykent Univesity

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

Related Publications (1)

  • Asik HK, Sahbaz T. Preventing chronic low back pain: investigating the role of Pilates in subacute management-a randomized controlled trial. Ir J Med Sci. 2025 Jun;194(3):949-956. doi: 10.1007/s11845-025-03939-y. Epub 2025 Apr 4.

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this clinical trial, masking will apply primarily to the Outcomes Assessor to ensure unbiased evaluation of results. The assessor, who will measure outcomes such as pain intensity, mobility, and quality of life, will be unaware of which intervention group (Pilates or home exercise) each participant belongs to. This masking minimizes the risk of bias in interpreting results based on prior knowledge of the intervention received by participants. If there are additional parties involved in data analysis or reporting who might influence the results, they will also be masked to the intervention assignments to maintain the integrity of the study outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study utilizes a parallel-group interventional study model to compare the effects of Pilates exercises versus a standard home exercise program on subacute low back pain. Participants are randomly assigned to one of two groups: Pilates Group: Participants in this group will receive a structured Pilates program targeting core stability, flexibility, and posture correction, which is specifically designed for low back pain management. Pilates exercises will be supervised by a qualified instructor to ensure proper technique and safety. Home Exercise Group: Participants in this group will follow a standard home exercise regimen tailored to relieve low back pain. These exercises focus on general strength and flexibility but are not specific to Pilates techniques. Both groups will participate in their respective programs for eight weeks. Outcomes, including pain levels, functional mobility, and quality of life, will be measured at three time points: baseline, post-treatment, and follow
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 21, 2024

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations