Effects of 12-Week Clinical Pilates Exercises on Mechanical Low Back Pain
1 other identifier
interventional
63
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Jul 2020
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedSeptember 7, 2022
September 1, 2022
2.1 years
September 1, 2022
September 2, 2022
Conditions
Keywords
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
OTHERPatients 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.
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.
Eligibility Criteria
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)
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: 24994051BACKGROUNDStoll 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: 24830644BACKGROUNDManchikanti 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: 25395111BACKGROUNDvan 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: 11064524BACKGROUNDMaher 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: 15062718BACKGROUNDNatour 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Erkan KOZANOGLU, Professor
Cukurova University, Faculty of Medicine
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
- 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
- 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.
Individual participant data (IPD) of this study available to other researchers.