Therapeutic Low Laser Therapy and Kinesio Taping for Lateral Ankle Sprain
1 other identifier
interventional
62
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedFirst Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
November 19, 2025
CompletedNovember 19, 2025
September 1, 2024
4 months
August 26, 2025
November 17, 2025
Conditions
Keywords
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
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
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
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,
Eligibility Criteria
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
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: 32227271BACKGROUNDGhozy 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: 32026818BACKGROUNDGaddi 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: 35872766BACKGROUNDAbdelbasset 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