NCT04829513

Brief Summary

This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 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

Study Start

First participant enrolled

December 1, 2016

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

7.6 years

First QC Date

March 29, 2021

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain at rest

    Pain at rest will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.

    Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)

  • Pain at movement

    Pain at movement will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.

    Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)

Secondary Outcomes (2)

  • Patient Global Assessment

    Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)

  • Oswestry Disability Index

    Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)

Study Arms (3)

Home Exercise

ACTIVE COMPARATOR

The group will be given a home exercise programme involving flexibility and strengthening of the lower back, hip girdle and sacroiliac region.

Procedure: Home Exercise

Home Exercise and Ligament Correction Kinesiotaping

ACTIVE COMPARATOR

In addition to the home exercise program, ligament correction kinesiotaping will be applied to the patients' sacroiliac region.

Procedure: Home ExerciseProcedure: Ligament Correction Kinesiotaping

Home Exercise and Lymphatic Correction Kinesiotaping

ACTIVE COMPARATOR

In addition to the home exercise program, lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region.

Procedure: Home ExerciseProcedure: Lymphatic Correction Kinesiotaping

Interventions

Home ExercisePROCEDURE

This is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region. These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms. Patients continue the exercises as a home programme once a day for 1 month.

Home ExerciseHome Exercise and Ligament Correction KinesiotapingHome Exercise and Lymphatic Correction Kinesiotaping

Ligament correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times.

Home Exercise and Ligament Correction Kinesiotaping

Lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times.

Home Exercise and Lymphatic Correction Kinesiotaping

Eligibility Criteria

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

You may qualify if:

  • Patients with sacroiliac joint dysfunction between the ages of 18-65

You may not qualify if:

  • Patients with rheumatological inflammatory disease
  • Inflamatory sacroiliitis
  • Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
  • Patients with a history of pelvic trauma
  • Patients with metabolic bone disease, infection, malignancy, pregnancy
  • Patients with open wounds in the lumbar and sacral area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Turkey (Türkiye)

Location

Study Officials

  • saime ay

    Ufuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 2, 2021

Study Start

December 1, 2016

Primary Completion

July 20, 2024

Study Completion

July 20, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations