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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Clinical Pilates Exercises

• Registration Number: NCT05529719
• Lead Sponsor: Cukurova University

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).

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-03
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	Clinical Pilates Exercises	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.

Primary Outcome Measures

Name	Time	Method
Prim Outcome - Oswestry Dysability Index	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 Outcome Measures

Name	Time	Method
Sec Outcome - Visual Analogue Scale	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.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey