Neuromuscular Subluxation of JointIESJMSWNCT06604312
The Immediate Effect of Sacroiliac Joint Manipulation in Standing Workers
A study testing Sacroiliac Joint Manipulation in people with Neuromuscular Subluxation of Joint and Physical Therapy, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine whether sacroiliac joint manipulation has a positive effect on muscle strength, balance and range of motion in standing workers. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neuromuscular Subluxation of Joint, Physical Therapy
- What is being tested?
- Sacroiliac Joint Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Sep 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having signed the voluntary consent form
- Being between the ages of 18-50
- Working standing for at least 3 hours a day
- Working standing for at least 6 months
- Suffering from low back pain in the last 6 months.
Who cannot join
- Having diseases that may cause balance problems
- Having a history of trauma in the last 6 months
- Pregnancy or suspicion of pregnancy
- Contraindications to chiropractic treatment (such as tumor, rheumatological condition, fracture, dislocation, metastasis and aneurysm)
- Feeling pain in the pelvis and sacroiliac joint,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effect of Sacroiliac Joint Manipulation on Postural Balance, Range of Motion and Muscle Strength in Standing Workers
The aim of this study was to determine whether sacroiliac joint manipulation has a positive effect on muscle strength, balance and range of motion in standing workers.
Read the detailed description
The study included 40 participants who were previously informed about the study, met the inclusion criteria and signed the consent form. Participants were randomly divided into two groups as sacroiliac joint manipulation group (n=20) and control group (n=20). Hip and lumbar range of motion was assessed with a goniometer, postural control and balance with Biodex, and quadriceps femoris and hamstring muscle strength with MicroFet®2. The sacroiliac joint manipulation group underwent sacroiliac joint manipulation and the control group did not undergo any procedure. The effect of the manipulation was measured immediately after the manipulation and the significance level was accepted as p\<0,05.
- Being tested
- Sacroiliac Joint Manipulation
- Keywords
- Chiropractic, Sacroiliac joint, Postural balance, Muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac Joint ManipulationOther
Sacroiliac manipulation was performed using manual treatment method by lying patients on their sides. First, the patient was positioned firmly on the edge of the examination table, while the restricted sacroiliac joint remains on the upper side. Then, the physician's hand was positioned on the patient's hip, and the flexion was made on the lumbar spine with the movement from the hip to the upper thigh, and the impulse given by the HVLA technique was applied in the anteroinferior direction to the iliac crest and trochanter major.
| Study group | Role | What they receive |
|---|---|---|
| Sacroiliac Joint Manipulation Group | Experimental | Sacroiliac joint manipulation was performed in lateral decubitis position. Receives: Other: Sacroiliac Joint Manipulation |
| Control Group | No intervention | The control group did not undergo any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System
Biodex Balance System (Biodex, Inc, Shirley, New York) (BDS) device was used to measure postural balance. It can extract anterior-posterior stability index (APSI), mediolateral stability index (MLSI) and overall stability index (OSI) for the measurement of standing posture control. Lower oscillation scores indicate better postural stability (Sung and Kim, 2018). The bipedal balance tests were performed with eyes open and closed and the volunteers were measured with their hands at their sides. The tests were performed for 30 seconds.
Measured: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Muscle Strength
Muscle strength measurements were performed with microFET ®2, a digital handheld dynamometer. The measurement is based on the compression principle and has high reliability and measurement accuracy. The results were recorded in kilograms of force (kgf) and measurements were taken from the quadriceps femoris and hamstring muscles.
Measured: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Range of Motion
Range of motion (ROM) measurements were performed with a universal goniometer. Degree was used as the unit of measurement. Flexion, extension, internal rotation, external rotation, abduction and adduction angles were measured bilaterally for the hip joint. Flexion, extension and lateral flexion (left-right) were measured in the lumbar region. For these values, the values determined by the American Association of Orthopedic Surgeons were taken as a basis, recorded during the measurement and proceeded in order.
Measured: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Subluxation of JointStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Forty volunteers participated in the study and these participants were divided into sacroiliac joint manipulation group (n=20) and control group (n=20). The sacroiliac joint manipulation was performed in the lateral decubitus position and the control group did not underwent any manipulation. Assessment methods were performed immediately after the manipulation. The frequency and percentage values for categorical variables and the mean, standard deviation, and median values for numerical data were displayed, respectively. Since there were less than thirty data points in each group, nonparametric tests were used to examine the data. The Mann-Whitney U test was used to compare the data between the two groups, and the Wilcoxon sign test was utilized to examine the difference between the two measures for each group. Measurement time differences were recorded, and the Mann-Whitney Test was used to compare the groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604312
- Sponsor's protocol ID
- CMT0005
- Acronym
- IESJMSW
- Status last verified
- Jul 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Sacroiliac Joint Manipulation on Postural Balance, Range of Motion and Muscle Strength in Standing Workers
- ClinicalTrials.gov ID
- NCT06604312
- Acronym / sponsor ID
- IESJMSW / CMT0005
- Keywords
- Chiropractic, Sacroiliac joint, Postural balance, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (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.
The aim of this study was to determine whether sacroiliac joint manipulation has a positive effect on muscle strength, balance and range of motion in standing workers.
Detailed description
The study included 40 participants who were previously informed about the study, met the inclusion criteria and signed the consent form. Participants were randomly divided into two groups as sacroiliac joint manipulation group (n=20) and control group (n=20). Hip and lumbar range of motion was assessed with a goniometer, postural control and balance with Biodex, and quadriceps femoris and hamstring muscle strength with MicroFet®2. The sacroiliac joint manipulation group underwent sacroiliac joint manipulation and the control group did not undergo any procedure. The effect of the manipulation was measured immediately after the manipulation and the significance level was accepted as p\<0,05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Forty volunteers participated in the study and these participants were divided into sacroiliac joint manipulation group (n=20) and control group (n=20). The sacroiliac joint manipulation was performed in the lateral decubitus position and the control group did not underwent any manipulation. Assessment methods were performed immediately after the manipulation. The frequency and percentage values for categorical variables and the mean, standard deviation, and median values for numerical data were displayed, respectively. Since there were less than thirty data points in each group, nonparametric tests were used to examine the data. The Mann-Whitney U test was used to compare the data between the two groups, and the Wilcoxon sign test was utilized to examine the difference between the two measures for each group. Measurement time differences were recorded, and the Mann-Whitney Test was used to compare the groups.
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac Joint Manipulation Group | Experimental | Other: Sacroiliac Joint ManipulationSacroiliac joint manipulation was performed in lateral decubitis position. |
| Control Group | No intervention | –The control group did not undergo any treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having signed the voluntary consent form
- Being between the ages of 18-50
- Working standing for at least 3 hours a day
- Working standing for at least 6 months
- Suffering from low back pain in the last 6 months.
Key exclusion criteria (5 listed)
- Having diseases that may cause balance problems
- Having a history of trauma in the last 6 months
- Pregnancy or suspicion of pregnancy
- Contraindications to chiropractic treatment (such as tumor, rheumatological condition, fracture, dislocation, metastasis and aneurysm)
- Feeling pain in the pelvis and sacroiliac joint,
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 |
|---|---|---|
| Sacroiliac Joint ManipulationSacroiliac manipulation was performed using manual treatment method by lying patients on their sides. First, the patient was positioned firmly on the edge of the examination table, while the restricted sacroiliac joint remains on the upper side. Then, the physician's hand was positioned on the patient's hip, and the flexion was made on the lumbar spine with the movement from the hip to the upper thigh, and the impulse given by the HVLA technique was applied in the anteroinferior direction to the iliac crest and trochanter major. | Other | Sacroiliac Joint Manipulation Group |
Primary outcome
Biodex Balance System
Time frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Biodex Balance System (Biodex, Inc, Shirley, New York) (BDS) device was used to measure postural balance. It can extract anterior-posterior stability index (APSI), mediolateral stability index (MLSI) and overall stability index (OSI) for the measurement of standing posture control. Lower oscillation scores indicate better postural stability (Sung and Kim, 2018). The bipedal balance tests were performed with eyes open and closed and the volunteers were measured with their hands at their sides. The tests were performed for 30 seconds.
Muscle Strength
Time frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Muscle strength measurements were performed with microFET ®2, a digital handheld dynamometer. The measurement is based on the compression principle and has high reliability and measurement accuracy. The results were recorded in kilograms of force (kgf) and measurements were taken from the quadriceps femoris and hamstring muscles.
Range of Motion
Time frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Range of motion (ROM) measurements were performed with a universal goniometer. Degree was used as the unit of measurement. Flexion, extension, internal rotation, external rotation, abduction and adduction angles were measured bilaterally for the hip joint. Flexion, extension and lateral flexion (left-right) were measured in the lumbar region. For these values, the values determined by the American Association of Orthopedic Surgeons were taken as a basis, recorded during the measurement and proceeded in order.
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 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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 Sacroiliac Joint Manipulation in people with Neuromuscular Subluxation of Joint and Physical Therapy, run by SEFA HAKTAN HATIK 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 5 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 19 Sep 2024. 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?
Biodex Balance System (time frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.). The study lists 3 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 19 Sep 2024.