- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791528
Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction
Assessing the Effects of Kinesiological Taping On Function And Pain Scores in Patients With Sacroiliac Joint Dysfunction
Low back pain is a common condition that affects 70% of people at least once. Sacroiliac joint Dysfunction (SIJD) is a skipped health problem that is ignored in patients with low back or hip pain. Fluoroscopy-guided SIJ injection showed that SIJD is a source of pain in 13-30% of patients with chronic low back pain. Inadequate function of SIJ leads to abnormal gait pattern, pain during walking, increase in load on discs, long-term interdisciplinary stability and causing to increase of the listhesis. The pain worsens with running, climbing stairs or standing up from the sitting position. Pharmacological, non-pharmacological and if required surgical treatment may be applied in the osteoarthritis treatment. Non-pharmacological treatment includes patient education, exercise, massaging, SIJ, manipulation-mobilization, chiropractic applications, physical therapy modalities, use of the assistive device.
Kinesio Taping is a treatment that has not been studied much and can be applied in SIJD. When investigators reviewed the literature, investigators found a study and a case report investigating the activity of Kinesio taping in sacroiliac joint dysfunction. Although the mechanism of Kinesio taping cannot be understood, it is claimed that it has four beneficial effects: normalizes muscular function, improves blood and lymphatic circulation, reduces pain, regulates possible disorders of joints. In studies showing the effectiveness of Kinesio banding in the reduction of pain in health problems related to the waist area with the highest number of publications, it was noted that the pain was reduced rapidly within three days, decreased the need for analgesics within two weeks and increased function in daily living activities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey, 35340
- Dokuz Eylul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients aged 18-60
Based on the diagnostic criteria proposed by the International Association for the Study of Pain (IASP):
i.Pain in the SIE region (hip/groin or lower extremity) ii.The pain felt in SIS, revitalized by specific provocation tests
- Patients with sacroiliac joint dysfunction and validity-validity-tested provocation tests, at least 3 of 6 tests are positive
1.Distraction 2.Compression 3.Gaenslen 4.POSH Test ( Thigh Thrust) 5.Sacral Push 6.FABER 4. Patients excluded from the presence of sacroiliitis by previous examinations and examinations 5. The signing of the informed consent form
Exclusion Criteria:
- Severe cognitive dysfunction
- The presence of a neurological deficit in the lower extremity
- Presence of known central nervous system or peripheral nervous system disease
- Presence of known rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, etc.)
- Have undergone major surgery for lower back and waist
- Pregnancy
- Spondylolisthesis
- Built-in osteoporosis
- The presence of malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kinesio-taping Treatment Group
In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the sacroiliac joint (SIJ), and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees.
evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire
|
In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees.
evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire.
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No Intervention: Control Group
Without Kinesio-taping treatment evaluated at baseline and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS ) for sacroiliac pain
Time Frame: Change from baseline pain score at 15 th day
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visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.
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Change from baseline pain score at 15 th day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Oswestry Pain Inquiry Form for pain and quality of life
Time Frame: All patients will evaluated at baseline, twentieth minute after application and on the 15th day.
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It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Each section is scored on a 0-5 scale, 5 representing the greatest disability.
The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage.
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All patients will evaluated at baseline, twentieth minute after application and on the 15th day.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Banu Dilek, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DorkuzEUTuran
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sacroiliac Joint Dysfunction
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University of AlbertaWithdrawnSacroiliac Joint Somatic DysfunctionCanada
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Cairo UniversityRecruitingSacroiliac Joint DysfunctionEgypt
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Zuyderland Medisch CentrumZuyd University of Applied SciencesCompleted
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