NCT06604312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

ChiropracticSacroiliac jointPostural balanceMuscle strength

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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.

Study Arms (2)

Sacroiliac Joint Manipulation Group

EXPERIMENTAL

Sacroiliac joint manipulation was performed in lateral decubitis position.

Other: Sacroiliac Joint Manipulation

Control Group

NO INTERVENTION

The control group did not undergo any treatment.

Interventions

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.

Sacroiliac Joint Manipulation Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Sinop, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

July 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Locations