Complex Regional Pain Syndrome Type INCT06302920
Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome
A study testing Kinesiotape in people with Complex Regional Pain Syndrome Type I, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- Kinesiotape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2024to 20 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of reflex sympathetic dystrophy Ability to be included in a physical therapy program
Who cannot join
- Hemiplegia Malignancy Polyacrylamide allergy Open wound in the area to be applied
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Antalya
Deniz Bulut, +90 05059445604, denizhava1988@gmail.com
Deniz Bulut
About this study
Official title: Investigation of the Effect of Kinesiotaping on Pain, Swelling and Kinesiophobia in Patients Diagnosed With Complex Regional Pain Syndrome
Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.
Read the detailed description
Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.
Kinesiology tapes have a wavy structure in line with the structure and physiological functions of the skin and have adhesive properties. The adhesive is a heat-activated acrylic. After approximately 20 minutes, the adhesive is fully activated. The tapes are porous, permeable to air and liquid, allow perspiration and dry quickly.Kinesiology tapes have a wavy structure in line with the structure and physiological functions of the skin and have adhesive properties. The adhesive is a heat-activated acrylic. After approximately 20 minutes, the adhesive is fully activated. The tapes are porous, permeable to air and liquid, allow perspiration and dry quickly. The method of application varies depending on the cutting method, application direction and region of the tape. If the anatomy of muscles, joints, ligaments and circulatory system is mastered and the correct techniques appropriate to the situation are used, the chance of success of the technique increases. Lymphatic correction technique is used to reorganize damaged lymphatic circulation. The main goals are to create a dead space in the tissue that allows circulation and to reduce the pressure on the lymph vessels at the tissue level. It directs lymph fluid to larger lymphatic vessels and lymph nodes. This effect can be explained by the elastic qualities and lifting effect of the tape. While lifting the surface skin reduces pressure and ensures lymphatic circulation, the tape provides a massage effect during active movement. Thanks to the tape, maximum contraction and relaxation of the muscles is ensured and the effectiveness of the deeper lymphatic flow is increased.
Kinesiophobia (also known as fear of movement); It is defined as an excessive and irrational fear of physical movement to avoid being harmed or injured again. It can also be expressed as an excessive, irrational fear of physical movement and activity resulting from a feeling of vulnerability due to pain. Its prevalence in chronic pain varies between 50-70%. While the existing threatening characteristics of the pain experience may vary depending on the situation and the person, avoidance behavior, which is protective in the short term, paradoxically worsens the problem in the long term. It is stated that kinesiophobia is an important factor in the transition of pain from acute to chronic stages.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- Kinesiotape
- Keywords
- complex regional pain syndrome, kinesiotaping, Kinesiophobia
- Medical subject headings
- Complex Regional Pain Syndromes, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
Lymphatic correction technique
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping group | Active comparator | Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. Receives: Device: Kinesiotape |
| Control group | No intervention | Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting pain
The resting pain level of the patients will be measured with the Visual Analogue Scale (VAS).A score between 0 and 10 will be determined by the patient, with 0 being no pain and 10 being the most severe pain level.
Measured: Beginning, week 3 and week 6
Edema
The patients will be physically examined and their wrist circumference and metacarpal circumference will be measured in centimeters.
Measured: Beginning, week 3 and week 6
Kinesiophobia
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia. A score above 37 in the test is defined as an indicator of a high level of kinesiophobia.
Measured: Beginning, week 3 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 May 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome Type IStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Bulut, Alanya Alaaddin Keykubat University
- Investigators
- Deniz Bulut, A.professor, Principal investigator, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302920
- Sponsor's protocol ID
- 0001
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer SGL, Zuurmond WWA, Birklein F, Loer SA, Perez RSGM. Anti-inflammatory treatment of Complex Regional Pain Syndrome. Pain. 2010 Nov;151(2):251-256. doi: 10.1016/j.pain.2010.07.020. Epub 2010 Aug 7. No abstract available.
PubMed 20692766Çeliker R, Güven Z, Aydoǧ T, et al. Kinezyolojik bantlama tekniǧi ve uygulama alanlari. Turkiye Fiz Tip ve Rehabil Derg. 2011;57(4):225-235.
Roelofs J, van Breukelen G, Sluiter J, Frings-Dresen MHW, Goossens M, Thibault P, Boersma K, Vlaeyen JWS. Norming of the Tampa Scale for Kinesiophobia across pain diagnoses and various countries. Pain. 2011 May;152(5):1090-1095. doi: 10.1016/j.pain.2011.01.028.
PubMed 21444153
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Kinesiotaping on Pain, Swelling and Kinesiophobia in Patients Diagnosed With Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT06302920
- Acronym / sponsor ID
- 0001
- Conditions
- Complex Regional Pain Syndrome Type I
- Keywords
- complex regional pain syndrome, kinesiotaping, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.
Detailed description
Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.
Kinesiology tapes have a wavy structure in line with the structure and physiological functions of the skin and have adhesive properties. The adhesive is a heat-activated acrylic. After approximately 20 minutes, the adhesive is fully activated. The tapes are porous, permeable to air and liquid, allow perspiration and dry quickly.Kinesiology tapes have a wavy structure in line with the structure and physiological functions of the skin and have adhesive properties. The adhesive is a heat-activated acrylic. After approximately 20 minutes, the adhesive is fully activated. The tapes are porous, permeable to air and liquid, allow perspiration and dry quickly. The method of application varies depending on the cutting method, application direction and region of the tape. If the anatomy of muscles, joints, ligaments and circulatory system is mastered and the correct techniques appropriate to the situation are used, the chance of success of the technique increases. Lymphatic correction technique is used to reorganize damaged lymphatic circulation. The main goals are to create a dead space in the tissue that allows circulation and to reduce the pressure on the lymph vessels at the tissue level. It directs lymph fluid to larger lymphatic vessels and lymph nodes. This effect can be explained by the elastic qualities and lifting effect of the tape. While lifting the surface skin reduces pressure and ensures lymphatic circulation, the tape provides a massage effect during active movement. Thanks to the tape, maximum contraction and relaxation of the muscles is ensured and the effectiveness of the deeper lymphatic flow is increased.
Kinesiophobia (also known as fear of movement); It is defined as an excessive and irrational fear of physical movement to avoid being harmed or injured again. It can also be expressed as an excessive, irrational fear of physical movement and activity resulting from a feeling of vulnerability due to pain. Its prevalence in chronic pain varies between 50-70%. While the existing threatening characteristics of the pain experience may vary depending on the situation and the person, avoidance behavior, which is protective in the short term, paradoxically worsens the problem in the long term. It is stated that kinesiophobia is an important factor in the transition of pain from acute to chronic stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping group | Active comparator | Device: KinesiotapePatients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. |
| Control group | No intervention | –Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of reflex sympathetic dystrophy Ability to be included in a physical therapy program
Key exclusion criteria (1 listed)
- Hemiplegia Malignancy Polyacrylamide allergy Open wound in the area to be applied
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 |
|---|---|---|
| KinesiotapeLymphatic correction technique | Device | Kinesiotaping group |
Primary outcome
Resting pain
Time frame: Beginning, week 3 and week 6
The resting pain level of the patients will be measured with the Visual Analogue Scale (VAS).A score between 0 and 10 will be determined by the patient, with 0 being no pain and 10 being the most severe pain level.
Edema
Time frame: Beginning, week 3 and week 6
The patients will be physically examined and their wrist circumference and metacarpal circumference will be measured in centimeters.
Kinesiophobia
Time frame: Beginning, week 3 and week 6
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia. A score above 37 in the test is defined as an indicator of a high level of kinesiophobia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 20692766Fischer SGL, Zuurmond WWA, Birklein F, Loer SA, Perez RSGM. Anti-inflammatory treatment of Complex Regional Pain Syndrome. Pain. 2010 Nov;151(2):251-256. doi: 10.1016/j.pain.2010.07.020. Epub 2010 Aug 7. No abstract available.
- BackgroundÇeliker R, Güven Z, Aydoǧ T, et al. Kinezyolojik bantlama tekniǧi ve uygulama alanlari. Turkiye Fiz Tip ve Rehabil Derg. 2011;57(4):225-235.
- Background: PubMed 21444153Roelofs J, van Breukelen G, Sluiter J, Frings-Dresen MHW, Goossens M, Thibault P, Boersma K, Vlaeyen JWS. Norming of the Tampa Scale for Kinesiophobia across pain diagnoses and various countries. Pain. 2011 May;152(5):1090-1095. doi: 10.1016/j.pain.2011.01.028.
- 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.
Deniz Bulut, A.professor principal investigator
Alanya Alaaddin Keykubat 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 Kinesiotape in people with Complex Regional Pain Syndrome Type I, run by Alanya Alaaddin Keykubat 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 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deniz Bulut, A.professor (+90 05059445604, denizhava1988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting pain (time frame: Beginning, week 3 and week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302920, which also lists 3 linked publications.
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 12 Mar 2024.