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Completed

NCT Number: NCT05529719

Effects of 12-Week Clinical Pilates Exercises on Mechanical Low Back Pain

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).

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Turkey (Türkiye)

About this study

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. The diagnosis of mechanical low back pain was made by a physical medicine and rehabilitation physician. Exercises are performed by an experienced physiotherapist with Clinical Pilates certification.

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).

Leading measures: Dysfunction was evaluated with the Oswestry Dysfunction Index. The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Low bak pain was evaluated with the Visual Analog Scale (VAS). VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. And flexibility was evaluated with the sit and reach test test. The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles. Measurements were performed at baseline and the end of the 12th week of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

  • Volunteers who did not meet the inclusion criteria were excluded.

Treatment and study plan

Clinical Pilates Exercises

Other

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.

Primary outcomes

  1. Prim Outcome - Oswestry Dysability Index

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. Sec Outcome - Visual Analogue Scale

    Time frame: 12 weeks

    Visual analog scale (VAS) scores were recorded to inquire about the pain status from the participants' registration information. In VAS, which is a horizontal line ten centimeters long, 0 indicates that there is no pain, while 10 indicates the most severe pain. Studies showed that VAS scores for those with chronic musculoskeletal pain corresponded to mild pain, 3.5 to 7.4 corresponded to moderate pain, and 7.5corresponds to severe pain.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Effects of 12-Week Clinical Pilates Exercises in Young Adults With Mechanical Low Back Pain a Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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