NCT07829354

Brief Summary

Occupational low back pain is a prevalent cause of functional disability. This randomized clinical trial aims to compare the effects of the Pilates Method and conventional kinesiotherapy on functional disability (Oswestry Index) and health self-perception in workers with occupational low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 9, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

PilatesKinesiotherapyExercise TherapyOccupational Health

Outcome Measures

Primary Outcomes (1)

  • Functional Disability

    Functional disability was assessed using the Oswestry Disability Index (ODI) questionnaire. The total score ranges from 0 to 100%, with higher scores indicating a worse outcome (greater level of disability).

    Baseline, 5 weeks, and 6 weeks

Secondary Outcomes (1)

  • Health Self-Perception

    Baseline, 5 weeks, and 6 weeks

Study Arms (2)

Pilates Method

EXPERIMENTAL

Participants underwent a rehabilitation protocol based on the Pilates Method.

Other: Pilates Method

Conventional Kinesiotherapy

ACTIVE COMPARATOR

Participants underwent a conventional kinesiotherapy exercise protocol.

Other: Conventional Kinesiotherapy

Interventions

A rehabilitation program utilizing the Pilates Method principles focusing on core stability, flexibility, and muscle strengthening.

Pilates Method

A standard physical therapy program involving stretching and strengthening exercises commonly used in clinical practice.

Conventional Kinesiotherapy

Eligibility Criteria

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

You may qualify if:

  • Workers diagnosed with occupational low back pain.
  • Aged between18 and older
  • Signed the Informed Consent Form.

You may not qualify if:

  • History of spinal surgery.
  • Presence of severe spinal pathologies (e.g., tumors, fractures, infections).
  • Pregnancy.
  • Currently participating in another physical rehabilitation program for low back pain.
  • Cognitive impairment that prevents understanding of the questionnaires or exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Clinic, Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, 38025-015, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dernival Bertoncello, PT, PhD

    Universidade Federal do Triângulo Mineiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor responsible for administering the clinical and functional questionnaires was blinded to the participants' group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the Pilates Method group or the conventional kinesiotherapy group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 21, 2026

Study Start

March 1, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations