Therapeutic Low Laser Therapy and Kinesio Taping for Lateral Ankle Sprain

November 17, 2025 updated by: University of Lahore

Therapeutic Low Laser Therapy and Kinesio Taping in Patients With Grade 1 and Grade 2 Lateral Ankle Sprain

HYPOTHESIS

Null Hypothesis (H0):

There is no significant effect of therapeutic low laser therapy and kinesio taping in patients with grade 1 & 2 lateral ankle sprain.

Alternative Hypothesis (HA):

There is a significant effect of therapeutic low laser therapy and kinesio taping in patients with grade 1 & 2 lateral ankle sprain.

Study Overview

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants are of both genders
  • Patients age will be from 20-40 years
  • Sub-acute ankle sprains (<2 weeks post-injury)
  • Grade 1& 2 lateral ankle sprains
  • A clinical diagnosis of at least one prior severe ankle sprain is required
  • Sensations of the ankle joint that it may "give way", recurrent sprain, or "looseness"
  • A score of Identification of Functional Ankle Instability of at least 11 (if both sides are equal, the lower functional side will be chosen)
  • Not allergic to KT

Exclusion Criteria:

  • Patients with a history of prior injury to the back, hip, knee, or severe injury to the ankle in the last two years
  • Systemic diseases like Rheumatoid arthritis, Diabetics, Neuropathies
  • Ankle fracture, subluxation, dislocation
  • The patient has received an intra-articular steroid injection in any recent operation of either of the two lower limbs.
  • Psychological disorders
  • Any spinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

Low-Level Laser Therapy (LLLT) Treatment

  • General Principles of LLLT for Ankle Sprains
  • Purpose: LLLT is used to improve circulation, lessen pain and inflammation, and promote tissue repair.
  • Mechanism of Action: By promoting mitochondrial activity, LLLT raises the synthesis of collagen and ATP. By releasing endorphins and increasing nitric oxide, it improves circulation, lowers inflammation, and regulates pain.

    2. LLLT parameters for lateral ankle sprains in grades 1 and 2 (initial step)

  • Wavelength: For deeper tissue penetration (targeting

    2. Kinesio Taping Application (Second Step) Kinesio taping is performed to support and stabilize the area of injury. By reducing discomfort and swelling, it may enhance comfort during activities.

For Grade 1 Sprains (Mild Injury) Technique:

  1. Y-Strip for Lateral Ankle Sprain: Place the tape at the base of the fifth metatarsal, or the dorsum of the foot.
  2. Wrap Around the Lateral Ankle: Wrap the two Y-shape tails around the lateral ankle,
Active Comparator: Group B
  1. Initial Assessment:

    Comprehensive evaluation is necessary to ascertain the degree of ankle sprain (Grade 1 or Grade 2), range of motion, discomfort, swelling, and functional restrictions at the beginning of treatment.

    • Grade 1 Sprain: Minimal swelling, mild ligament stretching, and no significant impairment of function.
    • Grade 2 Sprain: Moderate swelling, pain while bearing weight, reduced range of motion, and partial ligament treatment
  2. Low-Level Laser Therapy (LLLT) Treatment

    • General Principles of LLLT for Ankle Sprains Purpose: LLLT is used to improve circulation, lessen pain and inflammation, and promote tissue repair.

Mechanism of Action: By promoting mitochondrial activity, LLLT raises the synthesis of collagen and ATP. By releasing endorphins and increasing nitric oxide, it improves circulation, lowers inflammation, and regulates pain.

LLLT parameters for lateral ankle sprains in grades 1 and 2

• Wavelength: For deeper tissue penetration (targeting ligaments and te

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Disability Index
Time Frame: Baseline and at 12 weeks
The 34-item Foot and Ankle Disability Index is broken down into two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport. FADI has 26 items, whereas FADI Sport has only 8 items. FADI consists of 4 items dealing with pain and 22 items dealing with activities. 8 items in FADI-Sport are activity related. It tests more complex aspects that are crucial to sports. In contrast to FADI, FADI Sport is a subscale derived from the original population scale and specifically tailored for athletes. It is designed to fill this need by identifying the lower-functioning subjects in terms of the higher functions
Baseline and at 12 weeks
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and at 12 weeks
An outcome measure that provides a unidimensional gauge of pain intensity in adults. A respondent chooses an integer between 0 (no pain) and 10 (worst possible pain). Higher scores indicate greater pain severity.
Baseline and at 12 weeks
RANGE OF MOTION
Time Frame: Baseline and at 12 weeks
Range of Motion is the maximum movement a joint can achieve, assessed through active (AROM) and passive (PROM) methods, typically measured in degrees using a goniometer. Higher values indicate greater mobility.
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Actual)

March 22, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

August 26, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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