NCT07310368

Brief Summary

Sacroiliac joint dysfunction (SIJD) is a musculoskeletal condition associated with low back and pelvic pain, functional limitations, impaired postural control, and reduced spinal mobility. Although manual therapy techniques are commonly used in the conservative management of SIJD, evidence directly comparing joint-focused and fascial-focused approaches remains limited. This assessor-blinded, parallel-group randomized controlled trial compared sacroiliac joint mobilization and posterior chain-focused myofascial release, each applied in addition to a standardized conventional physiotherapy program, in adults aged 18-65 years with SIJD. Participants were randomly allocated in a 1:1 ratio to the mobilization group or the myofascial release group. Both groups received three supervised treatment sessions per week for six weeks. The primary outcomes were postural control assessed using the Biodex Balance System and spinal posture, mobility, postural endurance, and total Spine Check performance assessed using the Spinal Mouse system. Secondary outcomes were resting, activity-related, and night pain assessed using the Visual Analog Scale and functional disability assessed using the Oswestry Disability Index. Assessments were performed at baseline and immediately after the six-week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

December 16, 2025

Last Update Submit

August 10, 2026

Conditions

Keywords

Sacroiliac Joint DysfunctionMobilizationmyofascial release

Outcome Measures

Primary Outcomes (2)

  • Change in Static and Dynamic Postural Control

    Postural control will be assessed statically and dynamically. The Biodex balance system (Biodex Medical System Inc., NY, USA, SW45 30D E6N Model, SD 950 304) will be used. This device creates stability indices by evaluating movements in the overall, anterior-posterior, and medial-lateral directions. For static balance assessment, the subject is asked to hold a small circle containing a black dot representing their center of gravity without moving it for 20 seconds, repeated 3 times. For dynamic assessment, the floor movement level is set to 12 at the start and gradually reduced to 9 throughout the test. At these levels, the subject attempts to keep their center of gravity balanced within the small circle. Total, anterior-posterior (A-P), and medial-lateral (M-L) values are recorded. Increased values indicate worsening balance activity

    Baseline and immediately after the 6-week intervention.

  • Change in Posture, Spinal Mobility, Postural Endurance, and Total Spine Check Score

    It was measured using the computer-assisted wireless Spinal Mouse device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland). The Spinal Mouse device is moved over the spine using its wheel, measuring the length of the spine, posture, and joint movements, and transferring this sequence to a computer environment. It is a reliable method that can noninvasively measure the physical characteristics and movement of the spine in a practical way. Measurements are taken from the spinous process of the seventh cervical vertebra to the third sacral vertebra. For spinal mobility, the trunk flexion posture is recorded. For postural competence values, an upright posture measurement is performed, and then a weight equal to 5% of the person's body weight is held parallel between the shoulders for 30 seconds. After the weight is still in the person's hands, the upright posture is measured again

    Baseline and immediately after the 6-week intervention.

Secondary Outcomes (2)

  • Change in Resting, Activity-Related, and Night Pain

    Baseline and immediately after the 6-week intervention.

  • Disability

    6 week

Study Arms (2)

Myofascial Release

EXPERIMENTAL

Participants received posterior chain-focused myofascial release in addition to the standardized conventional physiotherapy program. Each technique was applied for approximately 90-120 seconds and repeated twice during each treatment session. The intervention included manual techniques targeting the erector spinae muscles, lumbosacral region, thoracolumbar and lumbar fascial structures, diaphragm-related fascial restrictions, gluteal fascia, and gluteus medius. Sustained cross-hand pressure, transverse knuckle pressure, lumbosacral decompression, fascial release, and distal-to-proximal deep massage techniques were used according to the targeted tissue and participant tolerance.

Other: Traditional treatment programOther: myofascial relaxation

Mobilization

EXPERIMENTAL

Participants received sacroiliac joint mobilization in addition to the standardized conventional physiotherapy program. The mobilization techniques were performed with the participant in side-lying and prone positions. The intervention included mobilization of the restricted sacroiliac joint in side-lying, controlled lumbar flexion, mobilization directed from the iliac crest toward the greater trochanter, caudal traction of the sacrum, mobilization of the sacrum relative to the ilium, and stretching techniques initiated from the iliac crests. Each mobilization technique was applied for 2 minutes using low-amplitude rhythmic movements within the participant's pain-free range. The technique was discontinued if pain increased or the participant was unable to tolerate the application.

Other: Traditional treatment programOther: Mobilization

Interventions

The myofascial release time for each muscle was 90 to 120 seconds, applied twice per session. 1. Myofascial release of the erector spinae muscles: the patient assumed a prone position; and the therapist stood at the patient's pelvis level on the treatment side, applying the cross-hand technique. 2. To increase muscle tension, the patient's lower extremity was placed in hip flexion and adduction at the highest point. The therapist stood behind the patient, at the level of the patient's pelvis, and applied the transverse tapping technique using the knuckles. 4. Myofascial release of the gluteus medius muscle: The patient assumed a lateral recumbent position on the untreated side. The therapist stood behind the patient, at the level of the patient's pelvis, and applied the vertical tapping technique using the knuckles.

Myofascial Release

Patients lay on their side with the sacroiliac joint restricted at the top, and sacroiliac manipulation was performed. Then, the physiotherapist flexed the lumbar spine by moving toward the upper part of the thigh, applying an impulse using the intermittent stretching technique in the direction of the major thoracanthus from the iliac crest. In the prone position, caudal traction, traction of the sacrum relative to the ilium, and traction stretches from the iliac crests will be applied.

Mobilization

Both groups received a standardized conventional physiotherapy program consisting of therapeutic exercise and therapeutic ultrasound. The exercises included bridging, trunk extension, and abdominal curl exercises and were performed in three sets of 15 repetitions. The exercises were progressed from initial to intermediate and advanced levels at two-week intervals when participants completed the prescribed sets with appropriate technique and without increased pain. Therapeutic ultrasound was applied over the right and left sacroiliac joint regions with the participant in the prone position. Continuous ultrasound was delivered at a frequency of 1 MHz and an intensity of 1.5 W/cm² using a 4-cm-diameter probe for a total duration of 6 minutes. Treatment was delivered three times per week for six weeks, for a total of 18 supervised sessions.

MobilizationMyofascial Release

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain localized to the sacroiliac joint region, with or without radiation to the hip, groin, or lower extremities.
  • Positive findings in at least three of five sacroiliac joint provocation tests: Vorlauf test, Gillet test, irritation point tenderness, posterior shear test, and compression test.
  • Pain intensity of at least 3 on the Visual Analog Scale. Voluntary participation and provision of written informed consent.

You may not qualify if:

  • Central or peripheral neurological disease or progressive neurological deficit. Rheumatological disease, including rheumatoid arthritis or ankylosing spondylitis.
  • Pregnancy or a severe systemic condition that could interfere with participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirşehir Ahi Evran University

Center, Kirşehi̇r, Turkey (Türkiye)

Location

Study Officials

  • Şafak KUZU

    Kirsehir Ahi Evran Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was not involved in intervention delivery and remained blinded to group allocation throughout the study. Participants were instructed not to disclose their treatment allocation to the assessor. Because of the nature of the manual therapy interventions, the treating physiotherapist and participants could not be blinded. Statistical analyses were conducted using a coded dataset, and group identities were concealed from the statistician until the analyses were completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group randomized controlled trial with 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

January 19, 2026

Primary Completion

March 20, 2026

Study Completion

April 20, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations