NCT07887100

Brief Summary

This study aims to compare plantar fascia thickness and pedobarometric parameters between individuals with sacroiliak joint dysfunction and healty individuals.A total of 52 adult volunteers aged 18 to 50 years were included in the study, with 26 pariticipants in the sacroiliac joint dysfunction group and 26 participants in the healty control group.Participants with sacroiliac joint dysfunction were identified based on clinical examination and sacroiliac joint pain provocation tests. Foot posture was evaluated using the Foot Posture Index-6 (FPI-6), and participants with neutral foot posture were included. Plantar fascia thickness of both feet was measured using ultrasound. Static foot pressure measurements were performed during standing with eyes open and closed, and dynamic foot pressure measurements were performed during walking using a pedobarometric system. The study compares plantar fascia thickness and pedobarometric parameters between the sacroiliak joint dysfunction and control groups. It also investigates the relationship between plantar fascia thickness and pedobarometric parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

October 15, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

Sacroiliac Joint DysfunctionPlantar fascia thicknesspedobarographyFoot Posture Index Scorepedobarometric

Outcome Measures

Primary Outcomes (9)

  • Plantar Fascia Thickness

    Plantar fascia thickness was measured by ultrasonography in the sagittal plane at the calcaneal insertion of the fascia. Three measurements were taken for each foot, and their mean was recorded in millimeters.

    At enrollment (single assessment visit)

  • Center of Force Ellipse Area

    Center of force (CoF) ellipse area was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded in square centimeters.

    At enrollment (single assessment visit)

  • Center of Force Path Length

    Center of force (CoF) path length was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded in centimeters.

    At enrollment (single assessment visit)

  • Center of Force Variability

    Center of force (CoF) variability was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded in centimeters.

    At enrollment (single assessment visit)

  • Center of Force Anteroposterior Excursion

    Center of Force Anteroposterior Excursion was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded in centimeters.

    At enrollment (single assessment visit)

  • Center of Force Mediolateral Excursion

    Center of Force Mediolateral Excursion was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded in centimeters.

    At enrollment (single assessment visit)

  • Total Foot Load

    The percentage of body weight borne by each foot was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded as a percentage of body weight.

    At enrollment (single assessment visit)

  • Forefoot Load

    The percentage of body weight borne by the forefoot region of each foot was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded as a percentage of body weight.

    At enrollment (single assessment visit)

  • Rearfoot Load

    The percentage of body weight borne by the rearfoot region of each foot was measured with a TekScan MatScan pressure mat under static (eyes open and eyes closed) and dynamic (three-step protocol) conditions. Each measurement was repeated three times, and the mean was recorded as a percentage of body weight.

    At enrollment (single assessment visit)

Study Arms (2)

Sacroiliac Joint Dysfunction Group

Patients with low back pain who were diagnosed with sacroiliac joint dysfunction when at least three of six pain provocation tests were positive on the same side. No intervention was applied. Plantar fascia thickness was measured by ultrasonography, and static and dynamic pedobarometric assessments were performed.

Healthy Control Group

Healthy volunteers without sacroiliac joint dysfunction, selected to be similar to the patient group in age, sex, and body mass index. No intervention was applied. Participants underwent the same ultrasonographic and pedobarometric assessments as the patient group.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with sacroiliac joint dysfunction were enrolled consecutively from individuals aged 18 to 50 years who presented with low back pain to the Physical Medicine and Rehabilitation outpatient clinic of Dokuz Eylul University Faculty of Medicine. Healthy volunteers of the same age range were recruited as controls from the staff of Dokuz Eylul University Faculty of Medicine and Faculty of Physical Therapy and Rehabilitation and through announcements in these units

You may qualify if:

  • Sacroiliac joint dysfunction group:
  • Age 18 to 50 years
  • Low back pain for at least 3 months, localized mainly around the posterior superior iliac spine, with or without radiation to the buttock or posterior thigh
  • At least three of six sacroiliac joint pain provocation tests (FABER, Gaenslen, thigh thrust, sacral thrust, compression, and distraction) positive on the same side
  • Foot Posture Index-6 score between 0 and +5 in both feet
  • Healthy control group:
  • Age 18 to 50 years
  • No diagnosis of sacroiliac joint dysfunction and no related complaints (all six sacroiliac joint pain provacation tests (FABER, Gaenslen, thigh thrust, sacral thrust, compression, and distraction) negative bilaterally )
  • Foot Posture Index-6 score between 0 and +5 in both feet

You may not qualify if:

  • Systemic rheumatologic disease (e.g., rheumatoid arthritis, ankylosing spondylitis)
  • Metabolic bone disease (e.g., osteoporosis, osteomalacia)
  • Active lumbar disc herniation or radiculopathy
  • Previous fracture, surgery, or structural deformity of the lower extremity
  • Pregnancy
  • Body mass index above 30 kg/m2
  • Diabetes mellitus and/or hypothyroidism
  • Regular exercise on more than three days per week
  • Occupation requiring prolonged standing (e.g., teacher, surgeon, waiter)
  • Walking more than 5 km per day
  • Physical therapy and/or injection treatment to the foot or ankle within the past 6 months
  • Previous diagnosis or history of plantar fasciitis
  • Central or peripheral nervous system disease (e.g., stroke, peripheral neuropathy, tarsal tunnel syndrome, Morton's neuroma)
  • Lower extremity length discrepancy of 1 cm or more
  • Use of orthopedic insoles, special footwear, or orthoses
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University

Izmir, 35330, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 21, 2026

Study Start

March 2, 2026

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

October 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared, as the protocol approved by the ethics committee specifies that study data will not be shared with third parties.

Locations