Total Knee ReplacementKT-TKRNCT06831682
Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery
A study testing Kinesiotaping (KT) and Standard Rehabilitation in people with Total Knee Replacement and Postoperative Recovery, run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
Trial summary
The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Postoperative Recovery, Rehabilitation Outcome
- What is being tested?
- Kinesiotaping (KT) and Standard Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years.
- Patients who have undergone primary Total Knee Replacement (TKR) with uncomplicated wound conditions.
- No signs of infection post-surgery.
- Ability to understand study procedures and complete required questionnaires.
Who cannot join
- Revision TKR surgeries.
- Early postoperative complications (e.g., wound healing disorders, deep infections, thrombosis).
- Severe comorbidities (e.g., heart failure NYHA class 3-4, renal insufficiency grade 3-4, chronic lymphedema, dermatological conditions).
- Known allergies to Kinesiotaping (KT) or adhesive materials.
- Neurological or neuromuscular disorders.
- Cognitive impairments (e.g., dementia) affecting compliance.
Trial locations and contacts
1 site in 1 country.
Germany1 site
SRH Health Center Bad Herrenalb
Bad Herrenalb, Bad Herrenalb, 76332
About this study
Official title: Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery- a Prospective Randomised Controlled Trial
The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint, compared to conventional rehabilitation without the use of KT.
Read the detailed description
Kinesiotaping and Rehabilitation after Total Knee Replacement The effectiveness of Kinesiotaping (KT) in postoperative rehabilitation remains scientifically unproven, despite its widespread use. KT is believed to reduce pain and swelling, improve muscle function, and enhance joint mobility by promoting blood flow and lymphatic drainage. However, high-quality studies assessing its efficacy, particularly following Total Knee Replacement (TKR), are lacking.
Aim of the Study The aim of this study is to demonstrate that KT, when applied during inpatient rehabilitation after TKR, improves clinical outcomes compared to standard rehabilitation without KT.
Specifically, the investigators aim to show that:
KT reduces postoperative swelling and pain, thereby enhancing knee function. KT promotes faster recovery of muscle strength and range of motion. KT shortens the time needed to achieve key postoperative milestones, allowing for a more effective rehabilitation process.
- Being tested
- Kinesiotaping (KT), Standard Rehabilitation
- Keywords
- Kinesiotaping, Total Knee Replacement, Rehabilitation, knee joint Function, Pain Relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotaping (KT)Device
Also called K-Active Tape
Kinesiotaping will be applied using muscle, lymphatic, and ligament taping techniques to promote healing, reduce swelling, and improve muscle function following total knee replacement surgery.
Standard RehabilitationOther
Patients will receive standard postoperative rehabilitation, including physiotherapy, gait training, and medical exercises, without the application of Kinesiotaping.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping group | Experimental | Patients in this group will receive Kinesiotaping (KT) in addition to standard rehabilitation following TKR surgery. KT will be applied using various techniques, including lymphatic, muscle, and ligament taping. Receives: Device: Kinesiotaping (KT); Other: Standard Rehabilitation |
| Control group (no KT) | Active comparator | Patients in this group will receive standard rehabilitation following TKR surgery without the application of Kinesiotaping. Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Using the Numeric Rating Scale (NRS)
Pain Level Using the Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst possible pain).
Unit of Measure: NRS score (0-10), where higher scores indicate worse pain.
Measured: From postoperative day 10 to postoperative day 25.
Knee Circumference (Swelling)
Knee Circumference (Swelling): The circumference of the operated knee will be measured using a standard tape measure at a consistent anatomical location.
Unit of Measure: Centimeters.
Measured: From postoperative day 10 to postoperative day 25.
Passive Range of Motion (PROM)
Passive Range of Motion (PROM): Knee joint mobility (flexion and extension) will be measured using a goniometer.
Unit of Measure: Degrees.
Measured: From postoperative day 10 to postoperative day 25.
Secondary outcomes (3)
Timed Up and Go Test
Timed Up and Go Test: Measures the time (in seconds) for a patient to rise from a chair, walk 3 meters, turn, and return to the chair.
Unit of Measure: Seconds (lower scores indicate better mobility).
Measured: From postoperative day 10 to postoperative day 25.
Chair Stand Test
Chair Stand Test: Measures the number of times a patient can rise from a chair and sit down within 30 seconds.
Unit of Measure: Count (higher scores indicate better lower limb strength).
Measured: From postoperative day 10 to postoperative day 25.
10-Meter Walk Test
10-Meter Walk Test: Measures the time taken to walk 10 meters at a self-selected pace.
Unit of Measure: Seconds (lower scores indicate better walking ability).
Measured: From postoperative day 10 to postoperative day 25.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start8 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SRH Gesundheitszentrum Bad Herrenalb
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andreas Veihelmann, MD, PhD, Study director, 1 SRH Health-center, Bad Herrenalb, Germany 2 Department of Orthopaedics, Physical Medicine & Rehabilitation, Ludwig-Maximilians- University of Munich, Munich, Germany 3 Department for Spine Therapy, Sports Hospital Stuttgart, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831682
- Sponsor's protocol ID
- Study2024-BadHerrenalb-01
- Acronym
- KT-TKR
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data that underlie the results reported in the publication, including data on primary and secondary outcomes (e.g., pain levels, knee circumference, range of motion, functional tests). Access to data will be available upon reasonable request to researchers conducting relevant studies. Data will be shared following publication and will be accessible for up to 5 years. Researchers must submit a formal proposal, and data sharing agreements will be required to protect privacy and confidentiality.
Publications
Al-Saadi A, Wegener B, Veihelmann A. Efficacy of kinesiotaping during rehabilitation following total knee arthroplasty: a prospective randomised controlled trial. J Rehabil Med. 2026 Jul 17;58:jrm44964. doi: 10.2340/jrm.v58.44964.
PubMed 42464852
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery- a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06831682
- Acronym / sponsor ID
- KT-TKR / Study2024-BadHerrenalb-01
- Keywords
- Kinesiotaping, Total Knee Replacement, Rehabilitation, knee joint Function, Pain Relief
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- SRH Gesundheitszentrum Bad HerrenalbResearch network
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint, compared to conventional rehabilitation without the use of KT.
Detailed description
Kinesiotaping and Rehabilitation after Total Knee Replacement The effectiveness of Kinesiotaping (KT) in postoperative rehabilitation remains scientifically unproven, despite its widespread use. KT is believed to reduce pain and swelling, improve muscle function, and enhance joint mobility by promoting blood flow and lymphatic drainage. However, high-quality studies assessing its efficacy, particularly following Total Knee Replacement (TKR), are lacking.
Aim of the Study The aim of this study is to demonstrate that KT, when applied during inpatient rehabilitation after TKR, improves clinical outcomes compared to standard rehabilitation without KT.
Specifically, the investigators aim to show that:
KT reduces postoperative swelling and pain, thereby enhancing knee function. KT promotes faster recovery of muscle strength and range of motion. KT shortens the time needed to achieve key postoperative milestones, allowing for a more effective rehabilitation process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping group | Experimental | Device: Kinesiotaping (KT), Other: Standard RehabilitationPatients in this group will receive Kinesiotaping (KT) in addition to standard rehabilitation following TKR surgery. KT will be applied using various techniques, including lymphatic, muscle, and ligament taping. |
| Control group (no KT) | Active comparator | Other: Standard RehabilitationPatients in this group will receive standard rehabilitation following TKR surgery without the application of Kinesiotaping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years.
- Patients who have undergone primary Total Knee Replacement (TKR) with uncomplicated wound conditions.
- No signs of infection post-surgery.
- Ability to understand study procedures and complete required questionnaires.
Key exclusion criteria (6 listed)
- Revision TKR surgeries.
- Early postoperative complications (e.g., wound healing disorders, deep infections, thrombosis).
- Severe comorbidities (e.g., heart failure NYHA class 3-4, renal insufficiency grade 3-4, chronic lymphedema, dermatological conditions).
- Known allergies to Kinesiotaping (KT) or adhesive materials.
- Neurological or neuromuscular disorders.
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 |
|---|---|---|
| Kinesiotaping (KT)Also: K-Active TapeKinesiotaping will be applied using muscle, lymphatic, and ligament taping techniques to promote healing, reduce swelling, and improve muscle function following total knee replacement surgery. | Device | Kinesiotaping group |
| Standard RehabilitationPatients will receive standard postoperative rehabilitation, including physiotherapy, gait training, and medical exercises, without the application of Kinesiotaping. | Other | Control group (no KT), Kinesiotaping group |
Primary outcome
Pain Level Using the Numeric Rating Scale (NRS)
Time frame: From postoperative day 10 to postoperative day 25.
Pain Level Using the Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst possible pain). Unit of Measure: NRS score (0-10), where higher scores indicate worse pain.
Knee Circumference (Swelling)
Time frame: From postoperative day 10 to postoperative day 25.
Knee Circumference (Swelling): The circumference of the operated knee will be measured using a standard tape measure at a consistent anatomical location. Unit of Measure: Centimeters.
Passive Range of Motion (PROM)
Time frame: From postoperative day 10 to postoperative day 25.
Passive Range of Motion (PROM): Knee joint mobility (flexion and extension) will be measured using a goniometer. Unit of Measure: Degrees.
3 secondary outcomes
Timed Up and Go Test
Time frame: From postoperative day 10 to postoperative day 25.
Chair Stand Test
Time frame: From postoperative day 10 to postoperative day 25.
10-Meter Walk Test
Time frame: From postoperative day 10 to postoperative day 25.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 42464852Al-Saadi A, Wegener B, Veihelmann A. Efficacy of kinesiotaping during rehabilitation following total knee arthroplasty: a prospective randomised controlled trial. J Rehabil Med. 2026 Jul 17;58:jrm44964. doi: 10.2340/jrm.v58.44964.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data that underlie the results reported in the publication, including data on primary and secondary outcomes (e.g., pain levels, knee circumference, range of motion, functional tests). Access to data will be available upon reasonable request to researchers conducting relevant studies. Data will be shared following publication and will be accessible for up to 5 years. Researchers must submit a formal proposal, and data sharing agreements will be required to protect privacy and confidentiality.
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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.
Andreas Veihelmann, MD, PhD study director
1 SRH Health-center, Bad Herrenalb, Germany 2 Department of Orthopaedics, Physical Medicine & Rehabilitation, Ludwig-Maximilians- University of Munich, Munich, Germany 3 Department for Spine Therapy, Sports Hospital Stuttgart, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping (KT) and Standard Rehabilitation in people with Total Knee Replacement and Postoperative Recovery, run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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 Level Using the Numeric Rating Scale (NRS) (time frame: From postoperative day 10 to postoperative day 25.). 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 NCT06831682, which also lists 1 linked publication.
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 18 Feb 2025.