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Sacroiliac Joint DysfunctionNCT07887100

Plantar Fascia Thickness and Pedobarometric Parameters in Sacroiliac Joint Dysfunction

An observational study of Sacroiliac Joint Dysfunction and Plantar Fascia Thickness, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Mar 2026to 1 Sep 2026
Phase
Observational
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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
  • History of serious foot trauma (e.g., moderate to severe ankle sprain)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University

    Izmir, 35330

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation of Plantar Fascia Thickness and Pedobarometric Parameters in Patients With Sacroiliac Joint Dysfunction

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.

Read the detailed description

This cross-sectional, comparative case-control study was designed to compare plantar fascia thickness and pedobarometric parameters between patients with sacroiliac joint dysfunction (SIJD) and healthy controls, and to examine the relationship between plantar fascia thickness and pedobarometric parameters in the patient group.

Patients 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 and met the eligibility criteria were enrolled consecutively. The control group consisted of healthy volunteers without SIJD, selected to be similar to the patient group in age, sex, and body mass index (BMI). Controls were recruited from the staff of the Faculty of Medicine and the Faculty of Physical Therapy and Rehabilitation and through announcements in these units. Written informed consent was obtained from all participants. The minimum sample size, calculated with G*Power 3.1.9.7 (d = 0.80, alpha = 0.05, power = 80%), was 26 participants per group (52 in total).

Age, sex, occupation, height, weight, BMI, weekly exercise duration, daily step count, comorbidities, lower limb length discrepancy, and dominant foot were recorded. All assessments were completed on the same day by the same investigator, who was not blinded to group status.

SIJD was diagnosed in patients with pain around the posterior superior iliac spine when at least three of six provocation tests (FABER, Gaenslen, thigh thrust, sacral thrust, compression, and distraction) were positive on the same side. A test was considered positive when it reproduced the patient's familiar pain, and the affected side was recorded.

Foot posture was assessed with the Foot Posture Index-6 (FPI-6), which consists of six items with a total score ranging from -12 to +12. Only participants with scores between 0 and +5 (neutral foot posture) in both feet were included.

Plantar fascia thickness was measured by ultrasonography (GE Versana Premier, 4.2-13 MHz linear probe) with the participant lying prone. Measurements were taken in the sagittal plane at the calcaneal insertion of the fascia, and the mean of three measurements was recorded for each foot. Echogenicity, calcaneal spur, perifascial fluid, and Doppler vascularity were also recorded.

Pedobarometric assessment was performed barefoot on a TekScan MatScan pressure mat. Static measurements lasted 30 seconds and were taken with eyes open and eyes closed. Dynamic measurements were taken with the three-step protocol in both walking directions, so that each foot was recorded separately. Each measurement was repeated three times and averaged. Center of force (CoF) parameters (ellipse area, path length, variability, and anteroposterior and mediolateral excursion) and load distribution (% body weight) were recorded.

Data collection has been completed, and statistical analyses will be performed with IBM SPSS Statistics version 27. Depending on the distribution of the data, continuous variables will be compared between groups with the independent-samples t test or the Mann-Whitney U test, and categorical variables with the chi-square or Fisher's exact test. Associations between plantar fascia thickness and pedobarometric parameters will be assessed with Pearson or Spearman correlation analysis.Multivariable linear regression analysis will be used to identify factors associated with plantar fascia thickness.The Benjamini-Hochberg false discovery rate procedure will be applied for multiple comparions where appropriate. Effect sizes and 95% confidence intervals will be reported together with p values, and p < 0.05 will be considered statistically significant.

Keywords
Sacroiliac Joint Dysfunction, Plantar fascia thickness, pedobarography, Foot Posture Index Score, pedobarometric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07887100
Study groupRoleWhat they receive
Sacroiliac Joint Dysfunction GroupPatients 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 GroupHealthy 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At enrollment (single assessment visit)

  2. 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.

    Measured: At enrollment (single assessment visit)

  3. 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.

    Measured: At enrollment (single assessment visit)

  4. 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.

    Measured: At enrollment (single assessment visit)

  5. 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.

    Measured: At enrollment (single assessment visit)

  6. 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.

    Measured: At enrollment (single assessment visit)

  7. 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.

    Measured: At enrollment (single assessment visit)

  8. 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.

    Measured: At enrollment (single assessment visit)

  9. 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.

    Measured: At enrollment (single assessment visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start2 Mar 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887100
Sponsor's protocol ID
2026/02-19
Status last verified
Sep 2026
First submitted
15 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Sacroiliac Joint Dysfunction and Plantar Fascia Thickness, run by Dokuz Eylul University 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 9 inclusion and 16 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 21 Oct 2026. 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?

Plantar Fascia Thickness (time frame: At enrollment (single assessment visit)). The study lists 9 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 21 Oct 2026.

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