NCT07466368

Brief Summary

Participants were randomly divided into two groups: a Pilates group (n=20) and a Pilates and spine-total body manipulation group (n=20). Both groups received a total of 8 sessions, 2 days a week, for 50 minutes each; one group received only Pilates, while the other group received Pilates combined with spine-total body manipulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 4, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

manipulationpilatesspinal problems

Outcome Measures

Primary Outcomes (3)

  • Quality of Life Scale (SF-36)

    The SF-36 (Short Form) was used to assess participants' quality of life. It consists of a total of 36 items, including subgroups. The three major health domains included in the SF-36 are functional status, well-being, and general perception of health. These are: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general perception of health (5 items). An average score was calculated for each section. Scores for each section range from 0 to 100, with higher scores indicating better quality of life. Participants were asked to carefully read the questions and answer each question considering their current and past health status. Higher scores indicate higher quality of life. The Turkish version of this questionnaire was used in our study.

    I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation

  • Y Balance Test

    During the Y-balance test, it was emphasized that participants should be barefoot. Throughout the test, athletes were encouraged to stand on one leg and reach the maximum distance they could with the other leg in the anterior, posterolateral, and posteromedial directions. The test device was configured with an angle of 135° between the anterior and posterior directions, and 90° in the posterior direction. To increase the reliability of the test and reduce the learning effect, each athlete performed at least six trials with each leg. To minimize the effect of fatigue, during the actual test, three repetitions were performed in the anterior direction, followed by three repetitions each in the posteromedial and posterolateral directions with each leg. If athletes touched the ground with their other foot to maintain balance, did not return to the starting position, or removed their hands from their hips to maintain balance, the relevant trial was considered erroneous and invalidated. The

    I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation

  • Flexibility Tests

    Flexibility Tests Sit-and-reach test: Performed with a standard bench with a 0-50 cm measuring scale, the top surface of which is 15 cm further out than where the feet rest. Trunk Hyperextension: The starting value is taken by measuring the distance between the wall and the sternal notch. With pelvic support, the patient is asked to push their torso backward from the waist. The distance between the sternal notch and the wall is measured again, and the starting value is subtracted from this value to record the amount of movement in centimeters. Trunk Lateral Flexion: The distal end of the toe finger is marked on the thigh, then the patient is asked to slide their hand down the thigh and tilt their torso to the side. Cervical rotation: The patient sits, a long stick is placed in their mouth and squeezed. The pivot point is placed in the middle of the head, the fixed arm is parallel to the floor. The movable arm follows the stick held in their mouth.

    I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation

Secondary Outcomes (1)

  • VISUAL ANALOG SCALE

    I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation

Study Arms (2)

group 1: MT

ACTIVE COMPARATOR

Manual Therapy Group: 20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted. Manual therapy was performed after each 50-minute exercise session.

Behavioral: manuel therapyOther: pilates

group 2: control group

OTHER

20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted

Other: pilates

Interventions

manuel therapyBEHAVIORAL

The Pilates program performed by the participants was as follows: Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series The manual therapy program included: cervical, thoracic, and lumbar manipulation, upper and lower extremity manipulation, and temporomandibular joint manipulation.

Also known as: chriopractic, osteopathic manual therapy, pilates, reformer
group 1: MT
pilatesOTHER

The Pilates program performed by the participants was as follows: Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series

Also known as: exercise, flexibility, balance training
group 1: MTgroup 2: control group

Eligibility Criteria

Age18 Weeks - 70 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ability to communicate in Turkish
  • Willingness to participate in the study
  • Non-specific mechanical lower back pain
  • Non-specific mechanical neck pain
  • Non-specific spinal problems
  • Pain in the neck and shoulder girdle area
  • Myofascial pain syndrome -having been doing Pilates for at least 4 weeks

You may not qualify if:

  • Pregnancy
  • Acute lower back pain
  • Acute neck pain
  • Recent surgery
  • Idiopathic scoliosis
  • Positive vertebral artery test
  • Vertigo
  • Bone disease
  • Cortisone use
  • Having done Pilates for more than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlikli Yaşam Merkezi

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise Movement TechniquesExercisePliability

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMechanical PhenomenaPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator physiotherapist

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 12, 2026

Study Start

April 10, 2025

Primary Completion

June 28, 2025

Study Completion

July 3, 2025

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

According to the laws of the Republic of Türkiye, sharing personal data is prohibited.

Locations