NCT03791528

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

December 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

December 2, 2018

Last Update Submit

March 1, 2020

Conditions

Keywords

Sacroiliac Joint DysfunctionKinesio Taping Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Modified Oswestry Pain Inquiry Form for pain and quality of life

    All patients will evaluated at baseline, twentieth minute after application and on the 15th day.

Study Arms (2)

Kinesio-taping Treatment Group

ACTIVE COMPARATOR

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

Other: Kinesio-taping treatment group

Control Group

NO INTERVENTION

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

Interventions

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.

Kinesio-taping Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Study Officials

  • Banu Dilek

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

December 2, 2018

First Posted

January 2, 2019

Study Start

January 10, 2019

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations