NCT05529719

Brief Summary

Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain. Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory. Cases: A total of 63 mechanical low back pain volunteers were included. Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2020

Typical duration 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

July 3, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 1, 2022

Last Update Submit

September 2, 2022

Conditions

Keywords

Clinical PilatesLow back painTherapeutic Exercise

Outcome Measures

Primary Outcomes (1)

  • Prim Outcome - Oswestry Dysability Index

    Pain-related functional competence was evaluated with the Oswestry disability index (ODI). ODI is a questionnaire consisting of 10 questions measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleep, travel status, and cognitive status of pain. Each question is evaluated between 0-5 points, and the ratio of the received score to the total answered question score gives the patient score. It is known that functional competence decreases and disability increases as the total score increases. It is interpreted as 0% to 20% - minimum disability 20% to 40% - moderate disability; 40% to 60% - severe disability; 60% to 80% - disabled 80% to 100% - bed-bound (or exaggerated symptoms).

    12 weeks

Secondary Outcomes (1)

  • Sec Outcome - Visual Analogue Scale

    12 weeks

Study Arms (1)

Control group

OTHER

Patients assigned to the control group were given theoretical training and a brochure containing MBA information. The control group patients participating in the evaluation session were recommended to be included in the same clinical Pilates training conducted by the intervention group after the study was completed.

Other: Clinical Pilates Exercises

Interventions

Participants in the experimental group were included in the clinical Pilates intervention, which consisted of three weekly sessions for 50 minutes for 12 weeks. Clinical pilates sessions were performed by a clinically Pilates-certified instructor and a physiotherapist. The intervention was divided into three sections. Each session started with the warm-up section. The warm-up part started with breathing exercises, pelvic tilt centering, activation of deep trunk and pelvic floor muscles, and joint mobility. The Clinical Pilates exercises section consisted of matte level strength and flexibility exercises involving the trunk, upper and lower extremities. Finally, a cooling part was done that included some flexibility exercises.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 30 years of age; who had suffered from low back pain for at least three months; who had not used medication for low back pain in the last three months; who did not have a surgical history due to spinal problems; who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; who had not received any treatment related to low back within the last six months; who had not previously continued pilates exercise; and who had sufficient physical autonomy to participate in the physical activities required by the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

Related Publications (6)

  • Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.

    PMID: 24994051BACKGROUND
  • Stoll J. THE LUMBAR SPINE: Mechanical Diagnosis and Therapy, R.A. Orthopedics. 1982 Oct;5(10):1378-82. doi: 10.3928/0147-7447-19821001-15. No abstract available.

    PMID: 24830644BACKGROUND
  • Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.

    PMID: 25395111BACKGROUND
  • van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the cochrane collaboration back review group. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2784-96. doi: 10.1097/00007632-200011010-00011.

    PMID: 11064524BACKGROUND
  • Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004 Jan;35(1):57-64. doi: 10.1016/S0030-5898(03)00088-9.

    PMID: 15062718BACKGROUND
  • Natour J, Cazotti Lde A, Ribeiro LH, Baptista AS, Jones A. Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2015 Jan;29(1):59-68. doi: 10.1177/0269215514538981. Epub 2014 Jun 25.

    PMID: 24965957BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erkan KOZANOGLU, Professor

    Cukurova University, Faculty of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Due to the nature of the intervention, it was impossible to blind the participants and the researcher; however, we provided blinding during data collection.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a randomized controlled trial. Participants were randomly assigned to the intervention group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

July 3, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) of this study available to other researchers.

Shared Documents
STUDY PROTOCOL
Time Frame
Timeless
Access Criteria
No individual participant data will be shared. Results will be published by the investigators in academic journals.

Locations