Sacroiliac Joint DysfunctionNCT04829513
Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction
A study testing Home Exercise, Ligament Correction Kinesiotaping and Lymphatic Correction Kinesiotaping in people with Sacroiliac Joint Dysfunction, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Home Exercise, Ligament Correction Kinesiotaping and Lymphatic Correction Kinesiotaping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2016to 20 Jul 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sacroiliac joint dysfunction between the ages of 18-65
Who cannot join
- Patients with rheumatological inflammatory disease
- Inflamatory sacroiliitis
- Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
- Patients with a history of pelvic trauma
- Patients with metabolic bone disease, infection, malignancy, pregnancy
- Patients with open wounds in the lumbar and sacral area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Two Different Kinesiotape Applications in Addition to Exercise in Patients With Sacroiliac Joint Dysfunction: A Randomized Controlled Study
This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.
Read the detailed description
33 patients will be given a home exercise program that strengthens the waist and hip girdle (to be shown once in the hospital by a physiotherapist and the form of the exercises will be given), 33 patients will be given kinesiotaping (KT) with ligament correction technique with the exercise program, and 33 patients will be given kinesiotaping with lymphatic correction technique with the exercise program. Patients will do the exercises once a day for 1 month. KT will be repeated once a week for 3 weeks. When taping is performed, it will be kept for 5 days.The patients' pain at rest and during movement will be measured using the Visuel Analog Scale (VAS). Patient Global Assessment and Oswestry Disability Index (ODI) will be questioned. Evaluations will be performed before, 4th week and 1 month after treatment (8th week).
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Home Exercise, Ligament Correction Kinesiotaping, Lymphatic Correction Kinesiotaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ExerciseProcedure or surgery
This is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region. These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms. Patients continue the exercises as a home programme once a day for 1 month.
Ligament Correction KinesiotapingProcedure or surgery
Ligament correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times.
Lymphatic Correction KinesiotapingProcedure or surgery
Lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise | Active comparator | The group will be given a home exercise programme involving flexibility and strengthening of the lower back, hip girdle and sacroiliac region. Receives: Procedure: Home Exercise |
| Home Exercise and Ligament Correction Kinesiotaping | Active comparator | In addition to the home exercise program, ligament correction kinesiotaping will be applied to the patients' sacroiliac region. Receives: Procedure: Home Exercise; Procedure: Ligament Correction Kinesiotaping |
| Home Exercise and Lymphatic Correction Kinesiotaping | Active comparator | In addition to the home exercise program, lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region. Receives: Procedure: Home Exercise; Procedure: Lymphatic Correction Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest
Pain at rest will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
Measured: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
Pain at movement
Pain at movement will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
Measured: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
Secondary outcomes (2)
Patient Global Assessment
Patient Global Assessment in the last week will be questioned by Visuel Analog Scale. Patients will be asked to mark their global assessment on a 0-10 cm visual analog scale (0:very good -10: very poor). Lower values indicate better status.
Measured: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
Oswestry Disability Index
Oswestry Disability Index will be questioned to determine the level of disability.The degree of disability is quantified on a scale of 0 to 100%. As the total score increases, the level of disability also increases.
Measured: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Dec 2016
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Ay, Ufuk University
- Investigators
- saime ay, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829513
- Sponsor's protocol ID
- 15112016-5
- Status last verified
- Aug 2024
- First submitted
- 29 Mar 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Two Different Kinesiotape Applications in Addition to Exercise in Patients With Sacroiliac Joint Dysfunction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04829513
- Acronym / sponsor ID
- 15112016-5
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 2 Apr 2021 (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.
This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.
Detailed description
33 patients will be given a home exercise program that strengthens the waist and hip girdle (to be shown once in the hospital by a physiotherapist and the form of the exercises will be given), 33 patients will be given kinesiotaping (KT) with ligament correction technique with the exercise program, and 33 patients will be given kinesiotaping with lymphatic correction technique with the exercise program. Patients will do the exercises once a day for 1 month. KT will be repeated once a week for 3 weeks. When taping is performed, it will be kept for 5 days.The patients' pain at rest and during movement will be measured using the Visuel Analog Scale (VAS). Patient Global Assessment and Oswestry Disability Index (ODI) will be questioned. Evaluations will be performed before, 4th week and 1 month after treatment (8th week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Home Exercise | Active comparator | Procedure: Home ExerciseThe group will be given a home exercise programme involving flexibility and strengthening of the lower back, hip girdle and sacroiliac region. |
| Home Exercise and Ligament Correction Kinesiotaping | Active comparator | Procedure: Home Exercise, Procedure: Ligament Correction KinesiotapingIn addition to the home exercise program, ligament correction kinesiotaping will be applied to the patients' sacroiliac region. |
| Home Exercise and Lymphatic Correction Kinesiotaping | Active comparator | Procedure: Home Exercise, Procedure: Lymphatic Correction KinesiotapingIn addition to the home exercise program, lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with sacroiliac joint dysfunction between the ages of 18-65
Key exclusion criteria (6 listed)
- Patients with rheumatological inflammatory disease
- Inflamatory sacroiliitis
- Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
- Patients with a history of pelvic trauma
- Patients with metabolic bone disease, infection, malignancy, pregnancy
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 |
|---|---|---|
| Home ExerciseThis is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region. These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms. Patients continue the exercises as a home programme once a day for 1 month. | Procedure or surgery | Home Exercise, Home Exercise and Ligament Correction Kinesiotaping, Home Exercise and Lymphatic Correction Kinesiotaping |
| Ligament Correction KinesiotapingLigament correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times. | Procedure or surgery | Home Exercise and Ligament Correction Kinesiotaping |
| Lymphatic Correction KinesiotapingLymphatic correction kinesiotaping will be applied to the patients' sacroiliac region. Taping will be done once a week. It will be kept for 5 days. This application will be repeated 3 times. | Procedure or surgery | Home Exercise and Lymphatic Correction Kinesiotaping |
Primary outcome
Pain at rest
Time frame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
Pain at rest will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
Pain at movement
Time frame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
Pain at movement will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'. The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
2 secondary outcomes
Patient Global Assessment
Time frame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
Oswestry Disability Index
Time frame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
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 21 Aug 2024.
- Individual participant dataSharing planned: No
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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.
saime ay principal investigator
Ufuk 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 Home Exercise, Ligament Correction Kinesiotaping and Lymphatic Correction Kinesiotaping in people with Sacroiliac Joint Dysfunction, run by Ufuk 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 1 inclusion and 6 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 21 Aug 2024. 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?
Pain at rest (time frame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)). The study lists 2 primary outcomes in all. 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 21 Aug 2024.