NCT05089253

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

October 10, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

dry needlingkinesio tappingosteoarthritisQuadriceps

Outcome Measures

Primary Outcomes (4)

  • 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.

    4 weeks

  • 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.

    4 weeks

  • 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

    4 weeks

  • 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. 1. Flicker of contraction. 2. Full range of motion in the elimination of gravity. 3. Full range of motion against gravity. 4. Full range of motion against gravity with mild resistance. 5. Full range of motion against gravity with maximum resistance.

    4 weeks

Study Arms (2)

Dry needling

ACTIVE COMPARATOR

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

Other: Kinesio tapping

kinesio taping

ACTIVE COMPARATOR

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

Other: Dry Needling

Interventions

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.

kinesio taping

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.

Dry needling

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with osteoarthritis.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIMHS

New Delhi, 140011, India

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2021

First Posted

October 22, 2021

Study Start

October 6, 2021

Primary Completion

February 1, 2022

Study Completion

March 21, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations