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临床试验/NCT07466368
NCT07466368已完成不适用

REFORMER YAPAN NON-SPESİFİK OMURGA PROBLEMLİ OLGULARDA MANİPÜLASYONUN ETKİSİNİN DEĞERLENDİRİLMESİ

Istanbul Rumeli University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Quality of Life Scale (SF-36)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Weeks 至 70 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: manuel therapy (Behavioral)

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.

干预措施: pilates (Other)

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

干预措施: pilates (Other)

结局指标

主要结局

Quality of Life Scale (SF-36)

时间窗: 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

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.

Y Balance Test

时间窗: 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

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

Flexibility Tests

时间窗: 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 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.

次要结局

  • 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)

研究者

发起方
Istanbul Rumeli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Özufacık

principal investigator physiotherapist

Istanbul Rumeli University

研究点 (1)

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