Manual Therapy for ankle sprain

Completed

• Conditions: Other soft tissue disorders related to use, overuse and pressure,

• Registration Number: CTRI/2019/03/018262
• Lead Sponsor: Smt Kashibai Navle College of Physiotherapy

Brief Summary

This study is a parallel group single blind, placebo controlled randomised trial with the objective of comparing the effect of Mobilization with movement and conventional therapy with placebo and conventional treatment. Total 32 subjects with grade 1 or grade 2, acute or sub-acute ankle inversion sprain will be recruited  and will be allocated to either group with simple computer generated allocation. Worst pain intensity in the previous 24 will be measured on Numeric Rating Scale (NRS) for Pain as primary outcome. Secondary outcomes include  Foot Ankle Disability index (FADI), Ankle Functional dorsi-flexion range of motion, Peripheral sensitization by pain pressure threshold, Y balance test (YBT), Central sensitization by pain pressure threshold over mid-deltoid. Outcome measures will be assessed at baseline prior to treatment, at the end of 2 week, 1 month and 6 months post intervention.  Subjects will receive treatment for 2 weeks, 3 sessions per week, for a total of 6 sessions. Home exercise program will be given at the end of trial which will be progressed as per patient’ s response. After completing data collection, analysis will be done on intention to treat basis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Study Completion: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Grade 1 and 2 inversion acute and subacute ankle sprain.

Exclusion Criteria

1.Grade 3 ankle sprain 2.Associated fractures of the lower extremity 3.Any open wound around the ankle 4.Chronic ankle injury 5.If pain increases by 2 or more on the Numerical Rating Scale (NRS) during the MWM intervention 6.Contraindications to manual therapy 7.Contraindications to tape application 8.Withdrawal of informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Worst pain intensity in the previous 24 will be measured on Numeric Rating Scale (NRS) for Pain:	2 weeks, 1 month and 6 months post intervention
NRS is a single 11-point numeric scale with 0 representing “no pain†and 10 representing the “worst pain imaginable	2 weeks, 1 month and 6 months post intervention

Secondary Outcome Measures

Name	Time	Method
1. Ankle Disability by Foot Ankle Disability index (FADI)	2. Ankle Functional dorsiflexion range of motion

Trial Locations

Locations (1)

Smt Kashibai Navale College of Physiotherapy; 🇮🇳 Pune, MAHARASHTRA, India

Smt Kashibai Navale College of Physiotherapy

🇮🇳Pune, MAHARASHTRA, India

Neha Gogate

Principal investigator

7798989643

nehagog25@gmail.com