- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286760
MAT Pilates and MIHA Combined Exercise Programs in Patients With Nonspecific Back Pain
March 25, 2026 updated by: hazal genc, Istanbul Medipol University Hospital
Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients With Nonspecific Back Pain
Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients with Nonspecific Back Pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
None Selected
-
Istanbul, None Selected, Turkey (Türkiye), 34353
- Hazal GENÇ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between 25 and 45 years of age
- Having had back pain for the last 3 months
- The back pain not being due to a structural, traumatic, infectious, or tumor-related cause (i.e., no specific cause has been identified)
- Not having any serious cardiovascular, neurological, or orthopedic conditions that would --prevent participation in a physical exercise program
- Not having participated in a regular physical exercise program in the past 6 months
- Not having any contraindications to the use of a wearable EMS device (e.g., not having a pacemaker)
Exclusion Criteria:
- The back pain is associated with a specific pathology (e.g., spinal stenosis, fracture, tumor, infection, etc.)
- Being within the first 6 months of pregnancy or postpartum
- History of neurological disease (e.g., multiple sclerosis, peripheral neuropathy, spinal cord injury, etc.)
- Having a pacemaker or other electronic device in the body
- Pre-existing intolerance to EMS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIHA Combined Exercise Programs
|
MIHA Combined Exercise Programs
|
|
Active Comparator: MAT Pilates
|
MAT Pilates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Assessment
Time Frame: 12 weeks
|
An algometer will be used to measure pain levels.
We have identified three muscle groups for the algometer: Gluteus Medius, Erector Spinae, and Quadratus Lumborum.
A low level indicates greater sensitivity and weakness.
|
12 weeks
|
|
Endurance Assessment
Time Frame: 12 weeks
|
: Individual endurance is assessed using three movements: the Plank, Bridge Movement, and V-Sit position.
These selected movements target the anterior, posterior, and lateral core muscle groups, enabling an assessment of overall endurance.
|
12 weeks
|
|
Quality of Life Assessment
Time Frame: 12 weeks
|
Quality of life will be assessed using the Oswestry Disability Index.
It is used to evaluate the effect of the MAT Pilates and EMS-assisted exercise programs applied in the study on daily living activities.
The lower the total score, the less the disability.The Oswestry Disability Index (ODI) ranges from 0 (no disability) to 100 (maximum disability), with higher scores reflecting increased functional impairment.
|
12 weeks
|
|
Anxiety Assessment
Time Frame: 12 weeks
|
Individuals' anxiety levels are assessed using the Beck Anxiety Scale.
This assessment aims to compare individuals' anxiety levels before and after intervention.
A high score on the Beck Anxiety Scale indicates a higher level of anxiety.
The Beck Anxiety Inventory (BAI) is scored from 0 to 63, with higher scores indicating greater levels of anxiety.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Actual)
November 1, 2025
Study Completion (Actual)
December 25, 2025
Study Registration Dates
First Submitted
December 2, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Actual)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-78097791-020-4745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.