- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235943
Therapeutic Low Laser Therapy and Kinesio Taping for Lateral Ankle Sprain
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
|
Low-Level Laser Therapy (LLLT) Treatment
For Grade 1 Sprains (Mild Injury) Technique:
|
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Active Comparator: Group B
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and at 12 weeks
|
|
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.
|
Baseline and at 12 weeks
|
|
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.
|
Baseline and at 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UOL/IREB/25/09/0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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