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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791528
Other study ID # DorkuzEUTuran
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2019
Est. completion date June 21, 2019

Study information

Verified date March 2020
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study is a randomized, controlled study. 52 participants will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of hip and back pain, aged between 18-60 years. Participants have diagnosed as Sacroiliac Joint Dysfunction according to The International Association for the Study of Pain (IASP) diagnostic criteria. These participants will be divided into two groups randomly (Treatment group n:26, control group n:26). Because the therapeutic effect may be seen with unsealed banding in Kinesio taping and the placebo effect may not be evaluated, After the last evaluation, participants in both groups will be given the necessary treatment and since there is no study on this subject in the literature, no treatment was given to the control group due to the fact that the actual effect of banding was desired. The treated group received 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. Both groups were evaluated at baseline and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Pain Inquiry Form. The kinesiological taping group was also evaluated with VAS and positive SIJ pain provocation tests, 20 minutes after the first banding, to assess the acute effect.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date June 21, 2019
Est. primary completion date June 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1. Male and female patients aged 18-60

2. 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

3. 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:

1. Severe cognitive dysfunction

2. The presence of a neurological deficit in the lower extremity

3. Presence of known central nervous system or peripheral nervous system disease

4. Presence of known rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, etc.)

5. Have undergone major surgery for lower back and waist

6. Pregnancy

7. Spondylolisthesis

8. Built-in osteoporosis

9. The presence of malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 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.

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS ) for sacroiliac pain visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome. Change from baseline pain score at 15 th day
Secondary Modified Oswestry Pain Inquiry Form for pain and quality of life 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. All patients will evaluated at baseline, twentieth minute after application and on the 15th day.
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