Total Knee ReplacementtapingNCT03340584
The Clinical Observation on Taping After Total Knee Replacement
A study testing the Nine Castle Net Format Taping and traditional rehabilitation in people with Total Knee Replacement, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- the Nine Castle Net Format Taping and traditional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2017to 30 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- soft-tissue swelling and pain after total knee replacement
- agree to participate the study and signing of informed consent
Who cannot join
- severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling
- failure of important organs, such as heart, lung, liver and kidney
- deep venous thrombosis
- thrombophlebitis
- varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer)
- participants with infection in the areas close to the knee joint, or allergy to tape
- enrollment in another clinical trial involving physical therapy or an investigational drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Songhe Jiang
Wenzhou, Zhejiang, 325000
Songhe Jiang, Professor, 13600661860, 863191168@qq.com
About this study
Official title: The Effectiveness of the Nine Castle Net Format Taping After Total Knee Replacement in Early Postoperative Rehabilitation Period. A Randomized Controlled Trial
The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.
- Conditions
- Total Knee Replacement
- Being tested
- the Nine Castle Net Format Taping, traditional rehabilitation
- Keywords
- Total Knee Replacement, Taping, Rehabilitation, Edema, Pain
- Medical subject headings
- Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Nine Castle Net Format TapingOther
The intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days， for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.
traditional rehabilitationOther
traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The intervention group will be received the Nine Castle Net Format taping and the traditional rehabilitation throughout all hospitalization period.We will exchange the new taping for Every two days. Receives: Other: the Nine Castle Net Format Taping |
| The control group | Other | The control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy. Receives: Other: traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Knee Edema at 1 week
Leg Circumference Measurements
Measured: Baseline and at 1 week
Secondary outcomes (4)
Change from Baseline Activities of Daily Living (ADL) at 1 week
The Barthel index
Measured: Baseline and at 1 week
Change from Baseline Knee Pain at 1 week
Numeric Pain Rating Scale（NPRS）,Numeric Pain Rating Scale on a 1(no pain)to 10(worst pain imaginable)scale, 0 No pain,1 2 3 Mild pain, 4 5 6 Moderate pain,7 8 9 10 Worst possible pain
Measured: Baseline and at 1 week
Change from Baseline Knee range of motion at 1 week
The Range of Motion Measurements
Measured: Baseline and at 1 week
Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week
Manual Muscle Test（MMT）
Measured: Baseline and at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start25 Nov 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song-he Jiang, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340584
- Sponsor's protocol ID
- 2017PT1025
- Acronym
- taping
- Status last verified
- Jul 2019
- First submitted
- 8 Nov 2017
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Nine Castle Net Format Taping After Total Knee Replacement in Early Postoperative Rehabilitation Period. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03340584
- Acronym / sponsor ID
- taping / 2017PT1025
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Taping, Rehabilitation, Edema, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Nov 2017 (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 investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Other: the Nine Castle Net Format TapingThe intervention group will be received the Nine Castle Net Format taping and the traditional rehabilitation throughout all hospitalization period.We will exchange the new taping for Every two days. |
| The control group | Other | Other: traditional rehabilitationThe control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- soft-tissue swelling and pain after total knee replacement
- agree to participate the study and signing of informed consent
Key exclusion criteria (7 listed)
- severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling
- failure of important organs, such as heart, lung, liver and kidney
- deep venous thrombosis
- thrombophlebitis
- varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer)
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 |
|---|---|---|
| the Nine Castle Net Format TapingThe intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days， for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week. | Other | The intervention group |
| traditional rehabilitationtraditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week. | Other | The control group |
Primary outcome
Change from Baseline Knee Edema at 1 week
Time frame: Baseline and at 1 week
Leg Circumference Measurements
4 secondary outcomes
Change from Baseline Activities of Daily Living (ADL) at 1 week
Time frame: Baseline and at 1 week
Change from Baseline Knee Pain at 1 week
Time frame: Baseline and at 1 week
Change from Baseline Knee range of motion at 1 week
Time frame: Baseline and at 1 week
Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week
Time frame: Baseline and at 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
Related trials for Total Knee Replacement
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Nine Castle Net Format Taping and traditional rehabilitation in people with Total Knee Replacement, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 2 inclusion and 7 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 25 Jul 2019. 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 China. 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 Songhe Jiang (8613600661860, 863191168@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Knee Edema at 1 week (time frame: Baseline and at 1 week). 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 25 Jul 2019.