Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation

NCT04830098 | Completed DMC

• 1 other identifier: CHRİOEXERCİSE001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Individuals

Keywords

Spinal stabilization; Exercise; Manipulation; Chiropractic

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Short Form-36 change

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

• Beck Depression Inventory change

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

Study Arms (4)

Stabilization group

EXPERIMENTAL

Stabilization group will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes.

Other: Spinal stabilization exercises

Manipulation group

EXPERIMENTAL

Manipulation group be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks.

Other: Chiropractic manipulation

Stabilization and Manipulation group

EXPERIMENTAL

Stabilization and Manipulation group will be given both stabilization exercises and manipulation exercises.

Other: Spinal stabilization exercises; Other: Chiropractic manipulation

Control group

NO INTERVENTION

No application will be made in the control group.

Interventions

Spinal stabilization exercises OTHER

It will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes.

Stabilization and Manipulation group; Stabilization group

Chiropractic manipulation OTHER

It will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks.

Manipulation group; Stabilization and Manipulation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Gumushane University

Gümüşhane, 29000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Therapy and Rehabilitation Department

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: March 5, 2021
• Primary Completion: April 16, 2021
• Study Completion: May 17, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)