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Effect of Physical Therapy Modalities in Osteoarthritis

Primary Purpose

Osteo Arthritis Knee, Quadriceps Muscle Atrophy

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Dry Needling
Kinesio tapping
Sponsored by
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring dry needling, kinesio tapping, osteoarthritis, Quadriceps

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosed with osteoarthritis.

Exclusion Criteria:

  • Surgical procedures in the lower extremity in the last 6 months
  • neurological disorders
  • skin allergy
  • patient is under pain medications.

Sites / Locations

  • AIMHS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dry needling

kinesio taping

Arm Description

The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks.

The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks

Outcomes

Primary Outcome Measures

Western Ontario McMasters Universities Osteoarthritis index
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the Western Ontario McMasters Universities Osteoarthritis index indicate worse pain, stiffness, and functional limitations.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Visual Analogue scale
A Visual Analogue Scale is a measurement instrument that attempts to measure a characteristic or attitude that is thought to range across a range of values and cannot be easily measured directly. It is frequently used in epidemiologic and clinical research to assess the severity or frequency of different symptoms. For example, a patient's level of pain ranges from none to severe. From the patient's point of view, this spectrum appears continuous; their pain does not appear to have discrete jumps, as a categorization of none, mild, moderate, and severe would imply. The VAS was created in order to capture the concept of an underlying continuum. Pain intensity on the from 0 to 100. 0 represents no pain and 100 represents severe pain
Manual Muscle Testing
This method is also known as the Oxford scale involves testing key muscles in the patient's upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5. In this research, the quadriceps muscle will be assessed manually by the examiner. o means no power and 5 means good muscle strength. 0. No movement. Flicker of contraction. Full range of motion in the elimination of gravity. Full range of motion against gravity. Full range of motion against gravity with mild resistance. Full range of motion against gravity with maximum resistance.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2021
Last Updated
March 29, 2022
Sponsor
Majmaah University
Collaborators
Scientific research unit, AIHMS New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT05089253
Brief Title
Effect of Physical Therapy Modalities in Osteoarthritis
Official Title
Effect of Dry Needling and Kinesio Taping On Pain Strength and Balance of Quadriceps Muscle in Knee Osteoarthritis. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
Collaborators
Scientific research unit, AIHMS New Delhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to find the most effective treatment out of both techniques; Dry needling and Kinesio Taping for treating knee osteoarthritis (OA) in terms of pain, strength, and balance
Detailed Description
Knee osteoarthritis is also associated with a 50%-60% reduction in maximum quadriceps torque, possibly resulting from disuse atrophy and atherogenic inhibition. Kinesio taping is a term that comes from the field of kinesiology, because the application of the tape allows the body to move normally, and reacts to fascia via biomechanical or proprioceptive mechanisms. Kinesio tape is an elastic therapeutic tape that finds its application as an adjunct to professional activities in healthcare, rehabilitation, prevention, and sports. In circulatory pathologies, Kinesio tape has the function to promote the drainage of excess fluid, activating a lymphatic drainage response. Kinesio tape promotes better blood circulation and lymph flow in the treated area, and this principle can be used to drain the swelling in trauma and bruises to speed up the process of redistribution of the hematoma. Kinesio tape application decreases the surplus heat via friction reduction resulting in lifting the skin. It also has a good stabilizing effect. Kinesio tape was also used for treating sports and orthopedic injuries, and a variety of musculoskeletal disorders like osteoarthritis. For example, the research of Murray H. has shown an increase in the electromyographic quadriceps muscular activity with Kinesio tape application, applied by patients after ACL repair in the postoperative phase. Dry is a specific technique for the treatment of functional disorders of the skeleton muscles, fascia, and connective tissue. It can also be used to reduce pain, restore function and reduce structural defects in muscles and joints, the dry needling treatment approaches are based on three models (including models of radiculopathy, spinal sensitization, and myofascial trigger point model). The dry needling technique can be divided into superficial and deep techniques. Conservative treatment is advocated in patients with mild to moderate osteoarthritis of the knee. Because muscles weakness is associated with pain and physical dysfunction and influences the progression of disease in patients with knee osteoarthritis. Muscle strengthening is a key component in knee osteoarthritis Therefore, local strengthening exercise is prescribed more frequently than general exercise. A growing body of evidence shows that exercise improves knee joint function and decreases symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Quadriceps Muscle Atrophy
Keywords
dry needling, kinesio tapping, osteoarthritis, Quadriceps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Active Comparator
Arm Description
The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks.
Arm Title
kinesio taping
Arm Type
Active Comparator
Arm Description
The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
The subject will be in the supine position and receive dry needling. The first point will be at the medial femoral condyle of the knee joint line in vastus medialis muscles. The second point will be at the lateral femoral condyle of the knee joint line in vastus lateralis muscles. The third point will be above the base of the patella in the rectus femoris muscle. The fourth point will be 2cm above the third point in rectus femoris muscles. These four points were the most common places of trigger point at quadriceps muscles. Dry needling is affected on A-delta fibers. Therefore when superficial dry needling with a noxious stimulation leads to stimulation on A-delta fibers, the excitation remains almost 72 hours and gradually decreases. The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Kinesio tapping
Intervention Description
The subject will be in the supine position and receive Kinesio taping. The Kinesio tape application with no tension one Y strip with a length of 20 cm, an anchor of 2 cm. The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
Western Ontario McMasters Universities Osteoarthritis index
Description
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the Western Ontario McMasters Universities Osteoarthritis index indicate worse pain, stiffness, and functional limitations.
Time Frame
4 weeks
Title
Berg Balance Scale
Description
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Time Frame
4 weeks
Title
Visual Analogue scale
Description
A Visual Analogue Scale is a measurement instrument that attempts to measure a characteristic or attitude that is thought to range across a range of values and cannot be easily measured directly. It is frequently used in epidemiologic and clinical research to assess the severity or frequency of different symptoms. For example, a patient's level of pain ranges from none to severe. From the patient's point of view, this spectrum appears continuous; their pain does not appear to have discrete jumps, as a categorization of none, mild, moderate, and severe would imply. The VAS was created in order to capture the concept of an underlying continuum. Pain intensity on the from 0 to 100. 0 represents no pain and 100 represents severe pain
Time Frame
4 weeks
Title
Manual Muscle Testing
Description
This method is also known as the Oxford scale involves testing key muscles in the patient's upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5. In this research, the quadriceps muscle will be assessed manually by the examiner. o means no power and 5 means good muscle strength. 0. No movement. Flicker of contraction. Full range of motion in the elimination of gravity. Full range of motion against gravity. Full range of motion against gravity with mild resistance. Full range of motion against gravity with maximum resistance.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosed with osteoarthritis. Exclusion Criteria: Surgical procedures in the lower extremity in the last 6 months neurological disorders skin allergy patient is under pain medications.
Facility Information:
Facility Name
AIMHS
City
New Delhi
ZIP/Postal Code
140011
Country
India

12. IPD Sharing Statement

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Effect of Physical Therapy Modalities in Osteoarthritis

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