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Clinical Trials/NCT04830098
NCT04830098
Completed
Not Applicable

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 site in 1 country80 target enrollmentMarch 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Individuals
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Enrollment
80
Locations
1
Primary Endpoint
Y balance test change
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2021
End Date
May 17, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible Party
Principal Investigator
Principal Investigator

Mesut Arslan

Head of Therapy and Rehabilitation Department

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Y balance test change

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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