Lateral Ankle SprainNCT07235943
Therapeutic Low Laser Therapy and Kinesio Taping for Lateral Ankle Sprain
A study testing Using Low-Level Laser Therapy and Combined: Low Laser Therapy with Kinesio Taping in people with Lateral Ankle Sprain and Ankle Sprain 1St Degree, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lateral Ankle Sprain, Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
- What is being tested?
- Using Low-Level Laser Therapy and Combined: Low Laser Therapy with Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Using Low-Level Laser Therapy, Combined: Low Laser Therapy with Kinesio Taping
- Keywords
- Low-Level Laser Therapy (LLLT), Kinesio Taping, Ankle Injury Rehabilitation, Lateral Ankle Sprain, Grade 1 Ankle Sprain, Grade 2 Ankle Sprain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Low-Level Laser TherapyOther
- 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 TapingOther
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,
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Combined: Low Laser Therapy with Kinesio Taping |
| Group B | Active comparator | Not described Receives: Other: Using Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start24 Nov 2024
- Primary completion22 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235943
- Sponsor's protocol ID
- UOL/IREB/25/09/0059
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32227271Ghozy 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.
PubMed 32026818Gaddi 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.
PubMed 35872766Abdelbasset 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.
PubMed 33178306
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Low Laser Therapy and Kinesio Taping in Patients With Grade 1 and Grade 2 Lateral Ankle Sprain
- ClinicalTrials.gov ID
- NCT07235943
- Acronym / sponsor ID
- UOL/IREB/25/09/0059
- Keywords
- Low-Level Laser Therapy (LLLT), Kinesio Taping, Ankle Injury Rehabilitation, Lateral Ankle Sprain, Grade 1 Ankle Sprain, Grade 2 Ankle Sprain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Combined: Low Laser Therapy with Kinesio Taping |
| Group B | Active comparator | Other: Using Low-Level Laser Therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using Low-Level Laser Therapy1. 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 | Other | Group B |
| Combined: Low Laser Therapy with Kinesio TapingLow-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, | Other | Group A |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 32227271Kobayashi 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.
- Background: PubMed 32026818Ghozy 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.
- Background: PubMed 35872766Gaddi 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.
- Background: PubMed 33178306Abdelbasset 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Low-Level Laser Therapy and Combined: Low Laser Therapy with Kinesio Taping in people with Lateral Ankle Sprain and Ankle Sprain 1St Degree, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Disability Index (time frame: Baseline and at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07235943, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.