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临床试验/NCT04830098
NCT04830098已完成不适用

Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation in Healthy Individuals

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Y balance test change

研究概览

简要总结

It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals.

In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life.

详细描述

It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals.

In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life.

Eighty healthy individuals between the ages of 18-45 who voluntarily participated in the study from students or academic/administrative staff at Gümüşhane University were included in the study. The study program was explained to the participants in line with the Informed Consent Form. It was included in the study after the relevant form was signed by the participant.

Healthy individuals to participate in the study will be randomly divided into 4 groups; randomization will be done by "Research Randomizer" computer program. Group 1 Stabilization group (n = 20), Group 2 Manipulation group (n = 20), Group 3 Stabilization and Manipulation group (n = 20), Group 4 Control group (n = 20). Group 1 will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. Group 2 will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. Group 3 will be given both stabilization exercises and manipulation exercises. The fourth group will be followed as a control group and no application will be made. Prone plunk, side plunk and sorenson tests for muscular endurance in the individuals participating in the study; Quadriceps muscle strength for muscle strength assessment; Joint position sense for propioception; Y balance test for balance; Short Form-36 (SF-36) for quality of life; Beck Depression Inventory was planned to be evaluated before, after and 1 months for psychosomatic evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteer individuals (Female and Male),
  • Between the ages of 18-45,
  • No pain, trauma or surgery history in the last 6 months,
  • Without any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis),
  • Individuals who had not received any treatment for spinal problems before were included in the study.

排除标准

  • Conditions where chiropractic spinal manipulation is contraindicated (Inflammation, infection, malignancy, blood coagulation disorder, etc.)
  • Any injury during the working process,
  • Individuals who did not attend the work program regularly were not included in the study.

结局指标

主要结局

Y balance test change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

It was used for dynamic balance of individuals. The validity reliability of the test was determined by Plisky et al. ICC range was 0.85-0.01 intrarater and 0.99-1.00 interrater \[30\]. The amount of lying on the dominant extremities of the individuals was measured. The subject was asked to stand on one foot at the midpoint of the test setup and touch with the tip of the toe while maintaining his balance with the other foot in the anterior, posteromedial and posterolateral directions. The test was repeated 3 times in all directions, averaged and recorded in cm.

Side Plank Test change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

It evaluates the endurance of the lateral trunk flexor muscles. The participant is asked to lie on his side on the elbow with the legs in full extension. Participant is asked to lift the lower limbs so that the hips and back are aligned and maintain this position. The total time is recorded. If the participant dropped his hip, the time was stopped. Measurements were repeated on both sides, right and left.

Sorenson test change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

Participant lies face down with his torso hanging from the table above the Anterior Superior Iliac Spine (ASIS) level. Thighs and legs are stabilized using straps. Participant then places his hands diagonally on the shoulders and is asked to lift his body at the same level with the table. Participant is asked to hold this position as long as possible and the total time is recorded.

Quadriceps muscle strength change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

During the test, after the participant completed the maximum knee extension, the evaluator stabilized the applied thigh with one hand and placed the dynamometer perpendicular to the leg 1-2 cm above the level of the malleoli with the other hand. A thin towel was placed between the dynamometer and the leg so that the dynamometer did not hurt the leg during the measurement. During the test, the "make test" technique, which requires isometric contraction, was applied. (Make test is the protocol of the person applying the maximum force against the device while the meter keeps the dynamometer constant). After the knee extension was completed, the participant was asked to maintain the maximum isometric contraction for 5 seconds. The average of 3 consecutive maximum contraction measurement values made at 30-second intervals was calculated

Prone Plank Test change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

It is a valid and reliable test used to measure the endurance of core region muscles \[27\]. The participant is asked to lie face down and rise on their elbows and toes while keeping the body in a straight line. The total time is recorded. The time is stopped if the participant lowers or lifts his body.

Joint position sense change

时间窗: Before starting study, after the study is finished, 1 month after the end of the study

The knee to be evaluated in a closed and quiet environment was positioned at 60 degrees of flexion joint angle for five seconds, and the person was asked to perceive this angular position. Then, the knee was relaxed and the person was asked to return to the joint position he perceived and hold for five seconds at that point. The difference is considered as the error angle. The error angle was calculated by taking the average of 3 trials. Measurements were made with the participants' eyes closed

次要结局

  • Beck Depression Inventory change(Before starting study, after the study is finished, 1 month after the end of the study)
  • Short Form-36 change(Before starting study, after the study is finished, 1 month after the end of the study)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesut Arslan

Head of Therapy and Rehabilitation Department

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (2)

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