Mulligan Concept in the Treatment of Ankle Sprains

Mulligan Concept in the Treatment of Subacute Ankle Sprains: a Randomized Placebo Trial.

Aim of the study is to establish the efficiency of the mulligan concept vs a sham group (who will also serve as control). Patient with an subacute ankle sprains will be assess following the mulligan concept and then randomized in two groups: Mobilization with movement (MWM) group and Sham group. MWM group will receive 3 sets of 10 repetitions of treatment (i.e. passive accessory glide during an active dorsiflexion) while the sham treatment will do 3 sets of 10 active dorsiflexion with the hand of the Physiotherapist only apply on the skin. 3 sessions with 4 days apart will take place. outcomes will be measure before and after every sessions.

Study Overview

• Status: Completed
• Conditions: Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree
• Intervention / Treatment: Procedure: Mulligan concept; Procedure: Placebo

Detailed Description

All included subject will received the Mulligan concept assessment. First investigator will applied non-weight bearing inferior tibiofibular mobilization with movement (MWM), i.e. passive accessory glide in a posterior and superior direction on the inferior tibiofibular joint. If not painful, Weightbearing inferior tibiofibular MWM will be applied 6 times. it consist on applying a passive accessory glide on the subject while he/she is doing an active dorsiflexion of the injured ankle. Dorsiflexion range of motion, pain and function will be reassess. If either one of previously cited outcomes is improve, subject is considered respondents. If he/she feels any pain or no improvements at all, he/she will be considered non-respondents. If non-weight-bearing inferior tibiofibular MWM is painful, talocrural MWM will be apply, first in non-weightbearing and if painfree, in weight bearing position. Talocrural MWM consist on a posterior glide of the talus while the subject realized an active dorsiflexion of the injured ankle. Same outcomes as previsouly cited will be assess and will determine if the patient is respondent or non-respondent. If the subject is non-respondent of the talocrural MWM or if he/she felt any pain during the talocrural MWM, a non weightbearing cubometatarsal MWM, i.e. cranio-caudal glide of the lateral cubometatarsal joint during an active dorsiflexion of the injured ankle, will be applied. If painfree, a tape will be placed as to replicate the cubometatarsal MWM, and the patient will reassess ROM, pain and function with the tape to see whether he/she is a respondent or non respondent subject. If the subject is non-respondent to neither of the three MWM, he/she is considered a drop-out. Respondent patient will then be randomized into two groups: MWM group and Sham group. MWM group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions of preferential MWM (inferior tibiofibular, talocrural, cubometatarsal) while the sham group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions with the first investigator doing a light touch during an active dorsiflexion, mimicking the real MWM techniques. Outcomes will be measures at T0 (beginning of the treatment-beginning of the first session), T1 (end of the first session), T2 (beginning of the second session), T3 (end of the second session), T4 (beginning of the third session) and T5 (end of the treatment-end of the third session).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ankle sprain since 2 weeks to 12 weeks
• Grade 1 or 2 ankle sprain
• Asymetrical dorsi-flexion limitation

Exclusion Criteria:

• Acute or Grade 3 ankle sprain
• More than 12 weeks ankle sprain
• Any other trauma of the lower limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobilization with movement (MWM) group; Application of the Mulligan concept	Procedure: Mulligan concept; Mobilization with movement during an active dorsi-flexion of the ankle
Placebo Comparator: Sham group; Sham treatment	Procedure: Placebo; Sham mobilization with movement during an active dorsi-flexion of the ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ankle dorsiflexion Range of motion	Wall toe test (distance in cm and degree in °)	At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	a 10cm Visual Analog Scale	At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Stiffness sensation	Visual Analog Scale (VAS)	At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Dynamic function	Y-test	At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in fonctionnel movement	Forward step down test	At the beginning (Time1) of Day1 (Session1) and end of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.
Change inDaily-life function	Foot and Ankle Ability Measure (FAAM) questionnaire	At the beginning (Time1) of Day1 (Session1) and end (Time2) of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Philippe Mahaudens, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ankle sprain; manual therapy; Mulligan
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: 2018/21NOV/439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No