NCT02830958

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

July 6, 2016

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of change of pain on Visual Scale

    before then after using the tape

    Day 1

Secondary Outcomes (1)

  • Thigh circumference in centimeters (cm).

    Day 1,

Study Arms (2)

Kinesiotaping Group

EXPERIMENTAL

applied next to the lymphatic system from the validated methods Kinesiotaping®.

Device: Kinesiotaping

Ordinary tape Group

PLACEBO COMPARATOR

Installation of an ordinary tape (not having the characteristics of Curetape®).

Other: No intervention

Interventions

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.

Kinesiotaping Group

No intervention. Uses of an ordinary tape

Ordinary tape Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total hip arthroplasty (THA) anterior approach.

You may not qualify if:

  • Known allergy to acrylic
  • open wounds
  • psoriasis,
  • skin problems
  • On active tumor site,
  • lymphedema present before surgery,
  • circulatory disorders (phlebitis),
  • diabetes with neuropathy,
  • not speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • JOUFFROY Pomme, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 13, 2016

Study Start

February 16, 2016

Primary Completion

March 31, 2017

Study Completion

December 31, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations