Sacroiliac Joint DysfunctionNCT03791528
Is Kinesio Taping Treatment Effective in Sacroiliac Joint Dysfunction
A study testing Kinesio-taping treatment group in people with Sacroiliac Joint Dysfunction, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Kinesio-taping treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2019to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Spondylolisthesis
- Built-in osteoporosis
- The presence of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Kinesio-taping treatment group
- Keywords
- Sacroiliac Joint Dysfunction, Kinesio Taping Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio-taping treatment groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS ) for sacroiliac pain
visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.
Measured: Change from baseline pain score at 15 th day
Secondary outcomes (1)
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.
Measured: All patients will evaluated at baseline, twentieth minute after application and on the 15th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start10 Jan 2019
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
- Investigators
- Banu Dilek, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791528
- Sponsor's protocol ID
- DorkuzEUTuran
- Status last verified
- Mar 2020
- First submitted
- 2 Dec 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Kinesiological Taping On Function And Pain Scores in Patients With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03791528
- Acronym / sponsor ID
- DorkuzEUTuran
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Sacroiliac Joint Dysfunction, Kinesio Taping Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Kinesio-taping Treatment Group | Active comparator | Other: Kinesio-taping treatment groupIn 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 |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio-taping treatment groupIn 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. | Other | Kinesio-taping Treatment Group |
Primary outcome
Visual Analog Scale (VAS ) for sacroiliac pain
Time frame: Change from baseline pain score at 15 th day
visual analog scale, 0 minimum, 10 maximum score, higher values represent a worse outcome.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banu Dilek principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio-taping treatment group in people with Sacroiliac Joint Dysfunction, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS ) for sacroiliac pain (time frame: Change from baseline pain score at 15 th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.