Healthy Individuals Clinical Trial
Official title:
Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation in Healthy Individuals
Verified date | April 2021 |
Source | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 17, 2021 |
Est. primary completion date | April 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gumushane University | Gumushane |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Joint position sense change | 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 | Before starting study, after the study is finished, 1 month after the end of the study | |
Primary | Quadriceps muscle strength change | 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 | Before starting study, after the study is finished, 1 month after the end of the study | |
Primary | Y balance test change | 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. | Before starting study, after the study is finished, 1 month after the end of the study | |
Primary | Prone Plank Test change | 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. | Before starting study, after the study is finished, 1 month after the end of the study | |
Primary | Side Plank Test change | 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. | Before starting study, after the study is finished, 1 month after the end of the study | |
Primary | Sorenson test change | 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. | Before starting study, after the study is finished, 1 month after the end of the study | |
Secondary | Short Form-36 change | Developed to evaluate the quality of life, this scale was developed by Koçyigit et al. Turkish validity and reliability study was conducted by [33]. SF-36 is a 36-item scale that includes physical and mental health inquiries. The high score obtained from the scale, which is evaluated between 0 and 100 points, indicates good health. | Before starting study, after the study is finished, 1 month after the end of the study | |
Secondary | Beck Depression Inventory change | Hisli et al. It is a scale consisting of 21 items, whose Turkish validity and reliability study was conducted by [35]. The high score obtained from the scale, which is between 0 and 63 points, indicates the presence of high depression. 0-9 points are defined as minimal depression, 10-16 points mild depression, 17-29 points moderate depression, and 30-63 points severe depression. | Before starting study, after the study is finished, 1 month after the end of the study |
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