NCT05211544

Brief Summary

Osteoarthritis (OA) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 14, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Keywords

kinesio tapekinesiophobiatherapeutic ultrasoundexerciseultrasound

Outcome Measures

Primary Outcomes (2)

  • tampa scala of kinesiophobia

    It is developed to measure the fear of movement and reinjury. The scale will be measured at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment

    four weeks

  • thickness of the quadriceps muscle

    Muscle hypertrophy is expected with regular isometric and isotonic exercises. In order to investigate the muscle effect of the treatments, the thickness of the quadriceps muscle will be measured with an ultrasound device. Measurement will be made at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment

    four weeks

Secondary Outcomes (2)

  • western ontario and mcmaster universities osteoarthritis index

    four weeks

  • visual analog scale

    four weeks

Study Arms (3)

intervention group 1

ACTIVE COMPARATOR

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound.

Other: physical therapy modalities and exercise

intervention group 2

ACTIVE COMPARATOR

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week

Other: kinesio taping and exercise

control group

ACTIVE COMPARATOR

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks.

Other: exercise

Interventions

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound.

intervention group 1

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week

intervention group 2

30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks.

control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 50 ages Stage 2-3 osteoarthritis according to Kellgren Lawrence lectures

You may not qualify if:

  • Presence of acute infection The patient has a history of knee surgery Presence of rheumatological disease History of malignancy Major knee trauma Presence of crystal arthropathy Presence of acute trauma/fracture History of avascular necrosis The presence of contracture in the knee Using analgesic or anti-inflammatory drugs in the last 1 week Using oral or intramuscular corticosteroids in the last 3 months Intra-articular injection of the knee in the last 6 months Receiving physical therapy modalities from the knee area in the last 1 year Diseases such as dementia that may cause loss of cognitive functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeKinesiophobiaMotor Activity

Interventions

Physical Therapy ModalitiesExercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPhobic DisordersAnxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three group 1. exercise group 2. exercise and kinesiotape 3. exercise and physical therapy modalities
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

January 21, 2022

Primary Completion

March 21, 2022

Study Completion

April 21, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations