Healthy IndividualsNCT04830098
Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation
A study testing Spinal stabilization exercises and Chiropractic manipulation in people with Healthy Individuals, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Spinal stabilization exercises and Chiropractic manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 17 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation in Healthy Individuals
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.
Read the 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.
- Conditions
- Healthy Individuals
- Being tested
- Spinal stabilization exercises, Chiropractic manipulation
- Keywords
- Spinal stabilization, Exercise, Manipulation, Chiropractic
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal stabilization exercisesOther
It will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes.
Chiropractic manipulationOther
It will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chiropractic manipulation |
| Stabilization and Manipulation group | Experimental | Stabilization and Manipulation group will be given both stabilization exercises and manipulation exercises. Receives: Other: Spinal stabilization exercises; Other: Chiropractic manipulation |
| Control group | No intervention | No application will be made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before starting study, after the study is finished, 1 month after the end of the study
Secondary outcomes (2)
Short Form-36 change
Developed to evaluate the quality of life, this scale was developed by Koçyiğit 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.
Measured: Before starting study, after the study is finished, 1 month after the end of the study
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.
Measured: Before starting study, after the study is finished, 1 month after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start5 Mar 2021
- Primary completion16 Apr 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Arslan, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830098
- Sponsor's protocol ID
- CHRİOEXERCİSE001
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04830098
- Acronym / sponsor ID
- CHRİOEXERCİSE001
- Conditions
- Healthy Individuals
- Keywords
- Spinal stabilization, Exercise, Manipulation, Chiropractic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stabilization group | Experimental | Other: Spinal stabilization exercisesStabilization group will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. |
| Manipulation group | Experimental | Other: Chiropractic manipulationManipulation group be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. |
| Stabilization and Manipulation group | Experimental | Other: Spinal stabilization exercises, Other: Chiropractic manipulationStabilization and Manipulation group will be given both stabilization exercises and manipulation exercises. |
| Control group | No intervention | –No application will be made in the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal stabilization exercisesIt will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. | Other | Stabilization and Manipulation group, Stabilization group |
| Chiropractic manipulationIt will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. | Other | Manipulation group, Stabilization and Manipulation group |
Primary outcome
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
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
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.
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.
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.
2 secondary outcomes
Short Form-36 change
Time frame: Before starting study, after the study is finished, 1 month after the end of the study
Beck Depression Inventory change
Time frame: Before starting study, after the study is finished, 1 month after the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal stabilization exercises and Chiropractic manipulation in people with Healthy Individuals, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense change (time frame: Before starting study, after the study is finished, 1 month after the end of the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.