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Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction

Primary Purpose

Sacroiliac Joint Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio-taping treatment group
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Dysfunction focused on measuring Sacroiliac Joint Dysfunction, Kinesio Taping Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Kinesio-taping Treatment Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS ) for sacroiliac pain
visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2018
Last Updated
March 1, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03791528
Brief Title
Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction
Official Title
Assessing the Effects of Kinesiological Taping On Function And Pain Scores in Patients With Sacroiliac Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Dysfunction
Keywords
Sacroiliac Joint Dysfunction, Kinesio Taping Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio-taping Treatment Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Kinesio-taping treatment group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS ) for sacroiliac pain
Description
visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.
Time Frame
Change from baseline pain score at 15 th day
Secondary Outcome Measure Information:
Title
Modified Oswestry Pain Inquiry Form for pain and quality of life
Description
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.
Time Frame
All patients will evaluated at baseline, twentieth minute after application and on the 15th day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Dilek
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction

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