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

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.

Study Overview

• Status: Completed
• Conditions: Manipulation, Osteopathic; Pilates Exercise; Non-specific Spinal Problems
• Intervention / Treatment: Other: pilates; Behavioral: manuel therapy

Detailed Description

A study is planned at the LoveYour Body Healthy Living Center in Gaziantep, involving 20 clients with spinal problems who will receive 8 sessions of reformer pilates alone (2 days a week, 50 minutes each) and another 20 clients who will receive 8 sessions of reformer pilates and spinal-total body manipulation (2 days a week, 50 minutes each). The sample size was determined through a power analysis using a 5% significance level (α = 0.05), a moderate effect size (effect size = 0.5), and 80% test power (power = 0.80). The analysis, conducted using the G*Power program, calculated that a minimum of 35 participants is required. Participation in the study was voluntary, and initial assessments were conducted on the same day. Participants were defined as being over 18 years of age, volunteering to participate, and experiencing at least one of the following symptoms for at least 4 weeks: non-specific mechanical lower back pain, non-specific mechanical neck pain, non-specific spinal problems, or pain in the neck and shoulder girdle region, or diagnosed with myofascial pain syndrome. Exclusion included pregnant women, those with acute lower back and neck pain, those who had recently undergone surgery, those with idiopathic scoliosis, vertigo, or bone disease, those with a positive vertebral artery test, those using cortisone, and those who had been practicing Pilates for more than 3 months. Assessments were conducted on the day participants began and the day the program ended.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Gaziantep, Turkey (Türkiye)
    • Sağlikli Yaşam Merkezi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1: MT; 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.	Other: pilates; 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; Other Names: exercise; balance training; flexibility; Behavioral: manuel therapy; 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.; Other Names: osteopathic manual therapy; chriopractic; pilates; reformer
Other: group 2: control 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	Other: pilates; 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; Other Names: exercise; balance training; flexibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VISUAL ANALOG SCALE	The VAS is typically presented as a 10 cm line supported by verbal descriptors such as 'no pain' and 'worst imaginable pain'. The patient is asked to mark a 100 mm line to indicate pain intensity. The score is measured from the zero point to the patient's mark. An increase in the numerical score indicates increased pain among the volunteers participating in the study, while a decrease in the score indicates decreased pain.	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

Collaborators and Investigators

• Sponsor: Istanbul Rumeli University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Actual): June 28, 2025
• Study Completion (Actual): July 3, 2025

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 7, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pilates; manipulation; spinal problems
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Mechanical Phenomena; Physical Phenomena; Exercise; Exercise Movement Techniques; Pliability
• Other Study ID Numbers: IstanbulRumeliU-FTR-MÖ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the laws of the Republic of Türkiye, sharing personal data is prohibited.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No