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Completed

NCT Number: NCT07235943

Therapeutic Low Laser Therapy and Kinesio Taping for 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.

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Key information

Conditions

Lateral Ankle Sprain Ankle Sprain 1St Degree Ankle Sprain 2Nd Degree

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Using Low-Level Laser Therapy

Other
  • 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
  • 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

Combined: Low Laser Therapy with Kinesio Taping

Other

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 (initial step)
  • Wavelength: For deeper tissue penetration (targeting
  • 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:

  • Y-Strip for Lateral Ankle Sprain: Place the tape at the base of the fifth metatarsal, or the dorsum of the foot.
  • Wrap Around the Lateral Ankle: Wrap the two Y-shape tails around the lateral ankle,

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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