NCT06227078

Brief Summary

Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. This study aimed to investigate the Clinical and functional effects of kinesiotaping and physiotherapy in grade 2 osteoarthritis following degenerative meniscal tears in football players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable knee-osteoarthritis

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

September 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 17, 2024

Last Update Submit

January 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity - Visual analog scale

    The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."

    Baseline

  • Pain intensity - Visual analog scale

    The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."

    8 weeks

  • Pain intensity - Visual analog scale

    The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms."

    6 months

Secondary Outcomes (12)

  • Functional disability - WOMAC

    Baseline

  • Functional disability - WOMAC

    8 weeks

  • Functional disability - WOMAC

    6 months

  • Sports performance - Timed up and go test

    Baseline

  • Sports performance - Timed up and go test

    8 weeks

  • +7 more secondary outcomes

Study Arms (2)

Active Kinesiotaping + Physiotherapy

ACTIVE COMPARATOR

The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape with the desired amount of stretch, usually around 50-80% of its maximum stretch capacity. Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place. Physiotherapy: Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session. Strengthening exercises: 1. Quadriceps Sets: 2. Straight Leg Raises: 3. Seated Leg Press: 4. Hamstring Curls: 5. Calf Raises: * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks.

Device: Kinesiotaping

Placebo Kinesiotaping + Physiotherapy

PLACEBO COMPARATOR

The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape without stretch, Direct the tape along the muscle or joint in a specific pattern, such as "I," "Y," or "X" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place. Physiotherapy: Apply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session. Strengthening exercises: 1. Quadriceps Sets: 2. Straight Leg Raises: 3. Seated Leg Press: 4. Hamstring Curls: 5. Calf Raises: * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks.

Device: Kinesiotaping

Interventions

Kinesiotaping is commonly used in sports medicine and rehabilitation settings. It is applied by trained professionals, such as physiotherapists or athletic trainers, who are skilled in assessing individual needs and determining the appropriate taping technique for specific conditions. The tape is typically worn for several days, allowing for continuous therapeutic effects. It's important to note that while kinesiotaping has gained popularity, its effectiveness is still a subject of ongoing research, and its application should be part of a comprehensive treatment plan. Individual responses to kinesiotape may vary, and its use is often combined with other therapeutic interventions for optimal results.

Active Kinesiotaping + PhysiotherapyPlacebo Kinesiotaping + Physiotherapy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Knee Osteoarthritis:
  • Individuals with a confirmed diagnosis of knee osteoarthritis based on clinical and/or radiological assessments.
  • Mild to Moderate Knee OA:
  • Kinesiotaping may be more appropriate for individuals with mild to moderate knee OA rather than severe cases.
  • Presence of Pain and Discomfort:
  • Individuals experiencing pain, discomfort, or limitations in function related to knee osteoarthritis.
  • Functional Limitations:
  • Those with functional limitations in activities of daily living or reduced mobility due to knee OA.
  • No Contraindications:
  • Individuals without contraindications to kinesiotaping, such as skin allergies, infections, or open wounds in the application area.
  • Willingness to Participate:
  • Individuals who are willing to participate in and adhere to the kinesiotaping intervention.
  • Not Responsive to Other Conservative Treatments:
  • Those who have tried and not responded adequately to other conservative treatments for knee OA, such as exercise, physical therapy, or oral medications.
  • Absence of Serious Comorbidities:
  • +3 more criteria

You may not qualify if:

  • \. Skin Conditions:
  • Active skin infections, allergies, or open wounds in the area where kinesiotape is to be applied.
  • Skin conditions that may be aggravated or worsened by the adhesive in the tape. 2. Vascular Disorders:
  • Conditions that affect blood circulation, such as peripheral vascular disease, deep vein thrombosis, or other vascular disorders, which may be worsened by the application of kinesiotape.
  • \. Peripheral Neuropathy:
  • Individuals with peripheral neuropathy or other nerve disorders, as kinesiotaping may affect sensation, and there is a risk of injury or discomfort.
  • \. Cancer or Tumors:
  • Active cancer or tumors in the region where kinesiotape is to be applied, as kinesiotaping could interfere with cancer treatment or exacerbate symptoms.
  • \. Joint Instability:
  • Individuals with severe joint instability, as kinesiotape may not provide sufficient support for highly unstable joints.
  • \. Allergies to Tape Components:
  • Known allergies to the materials or adhesive used in kinesiotape. 7. Circulatory Disorders:
  • Severe circulatory disorders, which may be exacerbated by the pressure or tension applied by kinesiotape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saud Alrawilli

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gopal Nambi

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

September 1, 2021

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP
Time Frame
2 months

Locations