Replacement, Total HipNCT02830958
Postoperative Kinesio Taping Effect on Pain and Edema in Patients Who Underwent Total Hip Arthroplasty
A study testing Kinesiotaping in people with Replacement, Total Hip, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The hip is a commonly performed operation corresponding to a prosthetic joint replacement surgery whose effectiveness depends on the quality of architectural and mechanical reconstruction of the artificial hip, integrity and balance of the periarticular musculature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Replacement, Total Hip
- What is being tested?
- Kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2016to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip arthroplasty (THA) anterior approach.
Who cannot join
- Known allergy to acrylic
- open wounds
- psoriasis,
- skin problems
- On active tumor site,
- lymphedema present before surgery,
Show all 9Show fewer
- circulatory disorders (phlebitis),
- diabetes with neuropathy,
- not speaking.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The hip is a commonly performed operation corresponding to a prosthetic joint replacement surgery whose effectiveness depends on the quality of architectural and mechanical reconstruction of the artificial hip, integrity and balance of the periarticular musculature. To achieve this dual purpose, two elements are essential: access to the hip that best meets the musculature and is able to restore the balance, and adequate prosthesis. Despite the move towards a surgery less invasive hip replacement is a procedure that causes tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in about 30% of cases.
Several studies have shown that there are risk factors for chronic post-surgical pain. They are both related to patients but also to surgery. It is thus advantageous to reduce the postoperative pain, localized mainly in the trochanteric region, to decrease the risk of developing chronic post surgical pain. Now medical comunity know that the post-operative bruising and tissue damage are partly responsible for these pains.
Read more
The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s It is water resistant and retains its properties up to 5 days. It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.
Its designers also claim it would have a beneficial effect on the lymphatic and venous circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the pressure in the dermis and promoting lymphatic drainage through its mechanical action during movement.
The lymphatic system is responsible for the capture of waste from venous blood (catabolites, plasma proteins) and thus can promote the absorption of edema.
In his study, Donec highlights a significant decrease in pain and a higher absorption of postoperative edema in the Kinésiotape® group than in the control group in surgical patients with total knee arthroplasty .
The Curetape® band is used in the orthopedic surgery department since 2010 in current care.
Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients with a total hip replacement.
Read the detailed description
Main objectives / Secondary:
To evaluate the effect of the application of Kinésiotape® in patients undergoing a total hip replacement on pain and changes in the immediate postoperative edema.
Methodology :
- STUDY This will be a prospective randomized study in routine care, against placebo performed in the hospital group Paris Saint Joseph, 75014.
- Randomization:
Given the weakness of the literature on this subject Investigators opted for a trial randomization into 2 groups that will be made by the patient. The patient list will be balanced by randomly alternating blocks. the orthopedic ward staff and physiotherapists will not be informed of the first schedule to avoid a bias in the care of patients. An array of randomization will be created by an independent person in the study. This then randomly assign patients in both groups using Microsoft Excel.
- Time study The projected duration of patient recruitment will be adjusted to the rhythm of inclusions to reach 30 patients per group (to follow the normal distribution) or about 6 months of recruitment in the event of observing a strong effect of the tape on the pain.
Acquisition of data:
- Data collected Clinical data for categorization of patients will be identified (age, height (m) Weight (kg), sex).
Investigators will evaluate the postoperative edema by measuring the perimeter of thigh. [6] The perimeter will be measured in millimeters at 1/3 and 2/3 of the distance lateral condyle of the femur - the greater trochanter. The landmarks will be found by palpation and marked for replication, the data measured using a 150 cm graduated Bohin® tape in mm will be performed at the bedside by a student intern in physiotherapy.
To quantify postoperative pain, Investigators use a numerical scale presented in a questionnaire to the patient.
Investigators will note on the last day of patient hospitalization of the amount of analgesic received daily, hang postoperative hospitalization.
- Supports: data collection form.
- Conditions
- Replacement, Total Hip
- Being tested
- Kinesiotaping, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
The Kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting. Latex-free and wearable for days at a time, Kinesio® Tex Tape is safe for populations ranging from pediatric to geriatric, and successfully treats a variety of orthopedic, neuromuscular, neurological and other medical conditions.
No interventionOther
No intervention. Uses of an ordinary tape
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping Group | Experimental | applied next to the lymphatic system from the validated methods Kinesiotaping®. Receives: Device: Kinesiotaping |
| Ordinary tape Group | Placebo comparator | Installation of an ordinary tape (not having the characteristics of Curetape®). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of pain on Visual Scale
before then after using the tape
Measured: Day 1
Secondary outcomes (1)
Thigh circumference in centimeters (cm).
Before then after using the tape
Measured: Day 1,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start16 Feb 2016
- Primary completion31 Mar 2017
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Replacement, Total HipStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOUFFROY Pomme, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830958
- Sponsor's protocol ID
- Kinesiotaping PTH
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Kinesio Taping Effect on Pain and Edema in Patients Who Underwent Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02830958
- Acronym / sponsor ID
- Kinesiotaping PTH
- Conditions
- Replacement, Total Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- 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 hip is a commonly performed operation corresponding to a prosthetic joint replacement surgery whose effectiveness depends on the quality of architectural and mechanical reconstruction of the artificial hip, integrity and balance of the periarticular musculature. To achieve this dual purpose, two elements are essential: access to the hip that best meets the musculature and is able to restore the balance, and adequate prosthesis. Despite the move towards a surgery less invasive hip replacement is a procedure that causes tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in about 30% of cases.
Several studies have shown that there are risk factors for chronic post-surgical pain. They are both related to patients but also to surgery. It is thus advantageous to reduce the postoperative pain, localized mainly in the trochanteric region, to decrease the risk of developing chronic post surgical pain. Now medical comunity know that the post-operative bruising and tissue damage are partly responsible for these pains.
The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s It is water resistant and retains its properties up to 5 days. It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.
Its designers also claim it would have a beneficial effect on the lymphatic and venous circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the pressure in the dermis and promoting lymphatic drainage through its mechanical action during movement.
The lymphatic system is responsible for the capture of waste from venous blood (catabolites, plasma proteins) and thus can promote the absorption of edema.
In his study, Donec highlights a significant decrease in pain and a higher absorption of postoperative edema in the Kinésiotape® group than in the control group in surgical patients with total knee arthroplasty .
The Curetape® band is used in the orthopedic surgery department since 2010 in current care.
Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients with a total hip replacement.
Detailed description
Main objectives / Secondary:
To evaluate the effect of the application of Kinésiotape® in patients undergoing a total hip replacement on pain and changes in the immediate postoperative edema.
Methodology :
- STUDY This will be a prospective randomized study in routine care, against placebo performed in the hospital group Paris Saint Joseph, 75014.
- Randomization:
Given the weakness of the literature on this subject Investigators opted for a trial randomization into 2 groups that will be made by the patient. The patient list will be balanced by randomly alternating blocks. the orthopedic ward staff and physiotherapists will not be informed of the first schedule to avoid a bias in the care of patients. An array of randomization will be created by an independent person in the study. This then randomly assign patients in both groups using Microsoft Excel.
- Time study The projected duration of patient recruitment will be adjusted to the rhythm of inclusions to reach 30 patients per group (to follow the normal distribution) or about 6 months of recruitment in the event of observing a strong effect of the tape on the pain.
Acquisition of data:
- Data collected Clinical data for categorization of patients will be identified (age, height (m) Weight (kg), sex).
Investigators will evaluate the postoperative edema by measuring the perimeter of thigh. [6] The perimeter will be measured in millimeters at 1/3 and 2/3 of the distance lateral condyle of the femur - the greater trochanter. The landmarks will be found by palpation and marked for replication, the data measured using a 150 cm graduated Bohin® tape in mm will be performed at the bedside by a student intern in physiotherapy.
To quantify postoperative pain, Investigators use a numerical scale presented in a questionnaire to the patient.
Investigators will note on the last day of patient hospitalization of the amount of analgesic received daily, hang postoperative hospitalization.
- Supports: data collection form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping Group | Experimental | Device: Kinesiotapingapplied next to the lymphatic system from the validated methods Kinesiotaping®. |
| Ordinary tape Group | Placebo comparator | Other: No interventionInstallation of an ordinary tape (not having the characteristics of Curetape®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total hip arthroplasty (THA) anterior approach.
Key exclusion criteria (9 listed)
- Known allergy to acrylic
- open wounds
- psoriasis,
- skin problems
- On active tumor site,
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 |
|---|---|---|
| KinesiotapingThe Kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting. Latex-free and wearable for days at a time, Kinesio® Tex Tape is safe for populations ranging from pediatric to geriatric, and successfully treats a variety of orthopedic, neuromuscular, neurological and other medical conditions. | Device | Kinesiotaping Group |
| No interventionNo intervention. Uses of an ordinary tape | Other | Ordinary tape Group |
Primary outcome
Assessment of change of pain on Visual Scale
Time frame: Day 1
before then after using the tape
1 secondary outcome
Thigh circumference in centimeters (cm).
Time frame: Day 1,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
JOUFFROY Pomme, MD principal investigator
Fondation Hôpital Saint-Joseph
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 in people with Replacement, Total Hip, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 9 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 27 Apr 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
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?
Assessment of change of pain on Visual Scale (time frame: Day 1). 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 27 Apr 2023.