The Effects of Manipulation on Pain, Quality of Life, and Functional Activity in People Who Practice Pilates.
REFORMER YAPAN NON-SPESİFİK OMURGA PROBLEMLİ OLGULARDA MANİPÜLASYONUN ETKİSİNİN DEĞERLENDİRİLMESİ
1 other identifier
interventional
43
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2025
CompletedFirst Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedMarch 16, 2026
March 1, 2026
3 months
March 4, 2026
March 12, 2026
Conditions
Keywords
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 COMPARATORManual 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.
group 2: control group
OTHER20 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
Interventions
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.
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
Eligibility Criteria
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)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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.