Therapeutic Low Laser Therapy and Kinesio Taping for Lateral Ankle Sprain

NCT ID: NCT07235943

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-24
• Study Completion Date: 2025-05-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group Type: EXPERIMENTAL

Combined: Low Laser Therapy with Kinesio Taping

Intervention Type: 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.

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 B

Group Type: ACTIVE_COMPARATOR

Using Low-Level Laser Therapy

Intervention Type: OTHER

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

Interventions

Using Low-Level Laser Therapy

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

Intervention Type: OTHER

Combined: Low Laser Therapy with Kinesio Taping

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,

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 32227271 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32026818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35872766 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33178306 (View on PubMed)

Other Identifiers

UOL/IREB/25/09/0059

Identifier Type: -

Identifier Source: org_study_id