NCT06907433

Brief Summary

Objective: To evaluate the effects of rigid-taping and kinesiotaping (lymphatic correction) on pain, joint mobility and disability in patients with sacroiliac joint dysfunction (SIJD). Methods: A total of 84 patients with unilateral SJID were included in this randomized controlled study. Patients were divided into kinesiotaping (KT) (n=28), rigid-taping (RT) (n=28) and control (n=28) groups. Pain levels at rest and during movement with visual analog scale (VAS) (0-10 cm), Oswestry Disability Index (ODI), mobility and pain provocation tests were recorded on days 1 and 15.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable pain

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

November 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 25, 2025

Last Update Submit

March 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • pain intensity with movement and at rest on a 0-10 cm visual analog scale (VAS) scale (0=no pain, 10=unbearable pain)

    15 days

  • Oswestry Disability Index

    15 days

Secondary Outcomes (2)

  • The number of positive mobility test

    15 days

  • The number of positive pain provacation test

    15 days

Study Arms (3)

Kinesiotaping group

ACTIVE COMPARATOR
Other: Rigid tapingOther: Exercise

rigid taping group

ACTIVE COMPARATOR
Other: KinesiotapingOther: Exercise

exercise group

ACTIVE COMPARATOR
Other: KinesiotapingOther: Rigid taping

Interventions

The lymphatic correction technique described by Kase for use in sacroiliac sprains or inflammations was used in KT of the dysfunctional sacroiliac joint. While the patient is standing with the spine in a neutral position, the base part of the fan-shaped cut Kinesio tape will be attached approximately 2-3 inches (approximately 5-8 cm) above the dysfunctional sacroiliac joint. Then, the patient is asked to lean forward and rotate in the opposite direction to the dysfunctional side. The tail parts of the fan-shaped tape are passed downward and inward at a 45-degree angle over the sacroiliac joint and attached to the superior edge of the gluteus maximus. The base of another kinesio tape was attached approximately 2-3 inches (approximately 5-8 cm) below the dysfunctional sacroiliac joint, the tails of the fan-shaped tape were passed upward and inward at a 45-degree angle over the sacroiliac joint and attached approximately to the upper edge of the PSIS.

exercise grouprigid taping group

The technique specified in the study by Allah et al. was taken as a reference for RT of the dysfunctional sacroiliac joint. Patients were placed in a lateral position on their healthy side, with the affected side uppermost, hip flexed to 45 degrees, and the femur in a neutral position. The rigid tape was attached to the anterior superior iliac spine of the upper hip and pulled tight, and attached linearly to the posterior superior iliac spine. Another piece was attached between the same points, but in a curved shape with the opening facing downward.

Kinesiotaping groupexercise group

Patients in all 3 groups were shown an exercise program by a physiotherapist that included lumbopelvic stabilization, flexibility and strengthening exercises for the low back and hip, and were asked to apply the exercise program for 15 days by providing visual material showing the exercises.

Kinesiotaping grouprigid taping group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged 18-50 years
  • patients who had subacute and chronic (lasting longer than 1 month), mechanical type low back and/or hip pain thought to be due to unilateral SIJD (spreading between 3 cm above and 10 cm below the posterior superior iliac spine, not extending above the 5th lumbar vertebra)
  • patients who had at least 3 positive results out of 6 pain provocation tests for the sacroiliac joint.

You may not qualify if:

  • the presence of known infectious, inflammatory, tumoral and advanced degenerative diseases that may cause low back pain, pain referred from abdominal or pelvic organs, history of spine or hip fracture/surgery,
  • presence of nerve root involvement findings,
  • presence of pregnancy, presence of inflammatory pathology in routine blood tests seen at the examination application
  • presence of inflammatory or advanced degenerative changes in the sacroiliac joint in imaging methods,
  • presence of findings suggesting bilateral sacroiliac joint dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, 6520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 2, 2025

Study Start

November 1, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations