NCT07286760

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

December 2, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (4)

  • Pain Assessment

    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

  • Quality of Life Assessment

    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

    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

  • Endurance Assessment

    : 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

Study Arms (2)

MIHA Combined Exercise Programs

EXPERIMENTAL
Other: MIHA Combined Exercise Programs

MAT Pilates

ACTIVE COMPARATOR
Other: MAT Pilates

Interventions

MIHA Combined Exercise Programs

MIHA Combined Exercise Programs

MAT Pilates

MAT Pilates

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazal GENÇ

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 16, 2025

Study Start

August 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 25, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations