Efficacy of Kinesio Taping and Splinting in Ankle Sprain

NCT03634280 | Completed DMC

• 1 other identifier: 2018.05.1.02.045
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Question:Does kinesiotaping(KT) reduce oedema, pain, disability and increase range of joint motion on patients with acute ankle ligament injuries? Design:Two-group, randomised, controlled trial with blinded assessors. Participants:This study included 240 patients with acute ankle sprain.The patients were randomised using randomisation software and divided into two groups each comprising 120 patients. Intervention:Tape and splint were kept on the patients for 5 days. Outcome measures:The following parameters were evaluated before and after treatment: circumference measurement for severity of oedema(metatarsophalangeal joint,ankle circumference,5cm above the ankle,10cm above the ankle),visual analog scale(VAS) pain score,range of motion(ROM) for the ankle with goniometer and disability level via the Foot Function Index (FFI).

Conditions

Ankle Sprains

Keywords

Ankle Sprains; Kinesio Tape; Splint

Outcome Measures

Primary Outcomes (1)

• Disability

  Foot Function Index: The FFI is designed to measure both current state, defined as the past week, and change in status. It consists of 23 items grouped into three sub-scales. Because the FFI was developed for use with a predominately elderly outpatient population, it was designed to be both short and simple. The number of items was minimized to reflect this consideration. The sub-scales were formed to provide information on three unique aspects of function-foot pain, disability and activity limitation-as they related to foot pathology. A score is derived for each item by dividing the attached horizontal line into 10 equal segments and assigning a number ranging from 0 to 9 to each segment. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the patient indicated were applicable.

  5 minutes

Secondary Outcomes (3)

• Oedema

  3 minutes

• Pain of ankle

  1 minute

• Range of motion

  3 minutes

Study Arms (2)

Splinting

PLACEBO COMPARATOR

Splinting was applied to the patients' ankle in the second group(n=120). Splint were kept on the patients for 5 days for 23 hours a day. In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.

Other: Kinesio taping

Kinesio taping

EXPERIMENTAL

In this study, Kinesio Tape Tex Gold® kinesio tape over lateral ankle (5cm\*5m) is used. 120 participants were taped for a lateral ankle sprain. 50-mm wide and 0.5-mm thick KT was applied to the tendinomuscular meridian around the ankle with three I-shaped tapes. Initially, one I-shaped tape was applied along the course of the tibialis anterior muscle, and another I-shaped tape was then applied to the peroneus longus and brevis muscles. The third I-shaped tape was applied from the abductor digiti minimi muscle and wrapped around the ankle in a figure-of-eight shape to the abductor hallucis muscle, surrounding the ankle over the medial and lateral malleoli. The tape was applied to the skin by applying zero tension, and skin problems were avoided.

Other: Kinesio taping

Interventions

Kinesio taping OTHER

In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.

Also known as: Splinting

Kinesio taping; Splinting

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age older than 18 years
• Presence of ankle sprain without osseous pathology
• Injury having occurred within the last 72 h

You may not qualify if:

• Presence of fracture, open wound
• Motor or sensory deficits associated with injury
• Systemic oedema in the lower extremities related to the heart or kidney, venous diseases
• Past surgery

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Splints

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• TOMRIS DUYMAZ

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Model Details: The patients were randomised using randomisation software and divided into two groups each comprising 120 patients. Tape and splint were kept on the patients for 5 days.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: May 2, 2018
• Primary Completion: August 1, 2018
• Study Completion: September 25, 2018
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

TU (1)