Postoperative PainNCT04873921
Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction
A study testing sterile kinesio taping in people with Postoperative Pain and Edema, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Anterior cruciate ligament reconstruction (ACLR) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. ACLR is used as the gold standard in coping with pain, deformity, and instability for the patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Edema
- What is being tested?
- sterile kinesio taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 15 May 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who underwent anterior cruciate ligament reconstruction
Who cannot join
- with soft tissue or bone problems affecting the hip or ankle
- who any neurologic problems,
- who had any systematic rheumatic problems,
- had scoliosis,
- who had undergone orthopedic surgery before,
- who were obese (BMI> 30 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Sterile Kinesio Tape Applied During Anterior Cruciate Ligament Reconstruction on Edema, Pain and Range of Motion
Anterior cruciate ligament reconstruction (ACLR) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. ACLR is used as the gold standard in coping with pain, deformity, and instability for the patients. The most important factors affecting the success of both surgery and postoperative rehabilitation programs are edema, joint movement limitation and pain around the knee in the early postoperative period. If these parameters are managed well in the postoperative period, the quality of life of the patient increases much earlier. In this respect, kinesio taping treatment, which is practical, comfortable, and safe for the patient, is one of the complementary treatment modalities with positive clinical results. No researchers have studied the effects of Sterile Kinesio Tape applied during ACL reconstruction on edema, pain and range of motion in immediate care postoperatively. The purpose of our study İS to assess effects of Sterile Kinesio Tape application on postoperative edema, pain and range of motion after ACLR within 72 hours. Thirty-seven patients who have undergone ACLR will be recruited to our study. Patients will be randomized into 2 groups; Group 1: Sterile Kinesio tape application, Group 2: Control group. All patients will be assessed for pain intensity (with Visual Analog Scale-VAS), edema (with tape measurement) and range of motion (with goniometric measurement-knee flexion/extension). Assessments will be done every day for 3 days (a total of 3 measurements). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard during ACLR postoperative care. Group 2 will receive only standard postoperative care.
- Conditions
- Postoperative Pain, Edema
- Being tested
- sterile kinesio taping
- Keywords
- Kinesiotape, Anterior Cruciate Ligament Reconstruction, Edema, Pain, Range of Motion
- Medical subject headings
- Pain, Postoperative, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile kinesio tapingOther
Also called taping
Application area will be cleaned and dried prior to application to increase the adhesiveness of the tape and application will be done by an experienced physiotherapist during ACLR surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sterile Kinesio tape application | Experimental | Sterile Kinesio Taping application will be applied with Sterile Web Cut Kinesio Tape (Sterile Kinesio Tex Tape, Alberquerque, USA) without tension. Receives: Other: sterile kinesio taping |
| Group 2: Control group | No intervention | Group 2 will not receive any taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed (every day for 3 days) with Visual Analog Scale (VAS). VAS is a 10-cm line with no marks along it, anchored with the words "no pain" on one hand, and "the most severe pain" on the other. Patients will be simply instructed to place a mark along the line at a level representing the intensity of their pain during activity
Measured: 3 days
Edema Assessment
Edema will be assessed (every day for 3 days) with circumferential measurements in centimeters using basic tape measurement for ACLR knees at 5 levels: incision level, upper part of incision (5 cm above and 10 cm above) and lower part of incision (5 cm below and 10 cm below)
Measured: 3 days
Range of motion measurement
Range of motion measurement will be done (every day for 3 days) with universal goniometry for knee flexion and extension. Knee flexion and extension movements will be measured in the supine position for both knees. The measurements will be recorded in degrees
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Mar 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Patients are randomized into 2 groups; Group 1: Sterile Kinesio tape application (n=28), Group 2: Control group (n=28). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard postoperative care. Group 2 will receive only standard postoperative care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873921
- Sponsor's protocol ID
- KA 21/133
- Status last verified
- Jun 2021
- First submitted
- 30 Apr 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Sterile Kinesio Tape Applied During Anterior Cruciate Ligament Reconstruction on Edema, Pain and Range of Motion
- ClinicalTrials.gov ID
- NCT04873921
- Acronym / sponsor ID
- KA 21/133
- Conditions
- Postoperative Pain, Edema
- Keywords
- Kinesiotape, Anterior Cruciate Ligament Reconstruction, Edema, Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 5 May 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.
Anterior cruciate ligament reconstruction (ACLR) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. ACLR is used as the gold standard in coping with pain, deformity, and instability for the patients. The most important factors affecting the success of both surgery and postoperative rehabilitation programs are edema, joint movement limitation and pain around the knee in the early postoperative period. If these parameters are managed well in the postoperative period, the quality of life of the patient increases much earlier. In this respect, kinesio taping treatment, which is practical, comfortable, and safe for the patient, is one of the complementary treatment modalities with positive clinical results. No researchers have studied the effects of Sterile Kinesio Tape applied during ACL reconstruction on edema, pain and range of motion in immediate care postoperatively. The purpose of our study İS to assess effects of Sterile Kinesio Tape application on postoperative edema, pain and range of motion after ACLR within 72 hours. Thirty-seven patients who have undergone ACLR will be recruited to our study. Patients will be randomized into 2 groups; Group 1: Sterile Kinesio tape application, Group 2: Control group. All patients will be assessed for pain intensity (with Visual Analog Scale-VAS), edema (with tape measurement) and range of motion (with goniometric measurement-knee flexion/extension). Assessments will be done every day for 3 days (a total of 3 measurements). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard during ACLR postoperative care. Group 2 will receive only standard postoperative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized into 2 groups; Group 1: Sterile Kinesio tape application (n=28), Group 2: Control group (n=28). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard postoperative care. Group 2 will receive only standard postoperative care.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sterile Kinesio tape application | Experimental | Other: sterile kinesio tapingSterile Kinesio Taping application will be applied with Sterile Web Cut Kinesio Tape (Sterile Kinesio Tex Tape, Alberquerque, USA) without tension. |
| Group 2: Control group | No intervention | –Group 2 will not receive any taping |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who underwent anterior cruciate ligament reconstruction
Key exclusion criteria (6 listed)
- with soft tissue or bone problems affecting the hip or ankle
- who any neurologic problems,
- who had any systematic rheumatic problems,
- had scoliosis,
- who had undergone orthopedic surgery before,
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 |
|---|---|---|
| sterile kinesio tapingAlso: tapingApplication area will be cleaned and dried prior to application to increase the adhesiveness of the tape and application will be done by an experienced physiotherapist during ACLR surgery. | Other | Group 1: Sterile Kinesio tape application |
Primary outcome
Pain Intensity
Time frame: 3 days
Pain intensity will be assessed (every day for 3 days) with Visual Analog Scale (VAS). VAS is a 10-cm line with no marks along it, anchored with the words "no pain" on one hand, and "the most severe pain" on the other. Patients will be simply instructed to place a mark along the line at a level representing the intensity of their pain during activity
Edema Assessment
Time frame: 3 days
Edema will be assessed (every day for 3 days) with circumferential measurements in centimeters using basic tape measurement for ACLR knees at 5 levels: incision level, upper part of incision (5 cm above and 10 cm above) and lower part of incision (5 cm below and 10 cm below)
Range of motion measurement
Time frame: 3 days
Range of motion measurement will be done (every day for 3 days) with universal goniometry for knee flexion and extension. Knee flexion and extension movements will be measured in the supine position for both knees. The measurements will be recorded in degrees
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 22 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sterile kinesio taping in people with Postoperative Pain and Edema, run by Baskent 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 22 Jun 2021. 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 Intensity (time frame: 3 days). 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?
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 22 Jun 2021.