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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clinical Pilates Exercises
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Clinical Pilates, Low back pain, Therapeutic Exercise

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sec Outcome - Visual Analogue Scale
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.

Full Information

First Posted
September 1, 2022
Last Updated
September 2, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05529719
Brief Title
Effects of 12-Week Clinical Pilates Exercises on Mechanical Low Back Pain
Official Title
Effects of 12-Week Clinical Pilates Exercises in Young Adults With Mechanical Low Back Pain a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Clinical Pilates, Low back pain, Therapeutic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a randomized controlled trial. Participants were randomly assigned to the intervention group and control group.
Masking
None (Open Label)
Masking Description
Due to the nature of the intervention, it was impossible to blind the participants and the researcher; however, we provided blinding during data collection.
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Pilates Exercises
Intervention Description
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 Outcome Measure Information:
Title
Prim Outcome - Oswestry Dysability Index
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sec Outcome - Visual Analogue Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erkan KOZANOGLU, Professor
Organizational Affiliation
Cukurova University, Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) of this study available to other researchers.
IPD Sharing Time Frame
Timeless
IPD Sharing Access Criteria
No individual participant data will be shared. Results will be published by the investigators in academic journals.
Citations:
PubMed Identifier
24994051
Citation
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.
Results Reference
background
PubMed Identifier
24830644
Citation
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.
Results Reference
background
PubMed Identifier
25395111
Citation
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.
Results Reference
background
PubMed Identifier
11064524
Citation
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.
Results Reference
background
PubMed Identifier
15062718
Citation
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.
Results Reference
background
PubMed Identifier
24965957
Citation
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.
Results Reference
background

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

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