NCT07235943

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

August 26, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Low-Level Laser Therapy (LLLT)Kinesio TapingAnkle Injury RehabilitationLateral Ankle SprainGrade 1 Ankle SprainGrade 2 Ankle Sprain

Outcome Measures

Primary Outcomes (3)

  • Foot and Ankle Disability Index

    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)

    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

    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

Study Arms (2)

Group A

EXPERIMENTAL
Other: Combined: Low Laser Therapy with Kinesio Taping

Group B

ACTIVE COMPARATOR
Other: Using Low-Level Laser Therapy

Interventions

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

Group B

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,

Group A

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • Kobayashi T, Suzuki D, Kondo Y, Tokita R, Katayose M, Matsumura H, Fujimiya M. Morphological characteristics of the lateral ankle ligament complex. Surg Radiol Anat. 2020 Oct;42(10):1153-1159. doi: 10.1007/s00276-020-02461-3. Epub 2020 Mar 30.

    PMID: 32227271BACKGROUND
  • Ghozy S, Dung NM, Morra ME, Morsy S, Elsayed GG, Tran L, Minh LHN, Abbas AS, Loc TTH, Hieu TH, Dung TC, Huy NT. Efficacy of kinesio taping in treatment of shoulder pain and disability: a systematic review and meta-analysis of randomised controlled trials. Physiotherapy. 2020 Jun;107:176-188. doi: 10.1016/j.physio.2019.12.001. Epub 2019 Dec 9.

    PMID: 32026818BACKGROUND
  • Gaddi D, Mosca A, Piatti M, Munegato D, Catalano M, Di Lorenzo G, Turati M, Zanchi N, Piscitelli D, Chui K, Zatti G, Bigoni M. Acute Ankle Sprain Management: An Umbrella Review of Systematic Reviews. Front Med (Lausanne). 2022 Jul 7;9:868474. doi: 10.3389/fmed.2022.868474. eCollection 2022.

    PMID: 35872766BACKGROUND
  • Abdelbasset WK, Nambi G, Alsubaie SF, Abodonya AM, Saleh AK, Ataalla NN, Ibrahim AA, Tantawy SA, Kamel DM, Verma A, Moawd SA. A Randomized Comparative Study between High-Intensity and Low-Level Laser Therapy in the Treatment of Chronic Nonspecific Low Back Pain. Evid Based Complement Alternat Med. 2020 Oct 28;2020:1350281. doi: 10.1155/2020/1350281. eCollection 2020.

    PMID: 33178306BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

November 19, 2025

Study Start

November 24, 2024

Primary Completion

March 22, 2025

Study Completion

May 30, 2025

Last Updated

November 19, 2025

Record last verified: 2024-09

Locations