NCT04731350

Brief Summary

Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

January 16, 2021

Last Update Submit

March 5, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale (VAS)

    pain intensity will be assessed by using visual analogue scale

    change from baseline to immediately pre treatment and from pre treatment to immediately post treatment

Secondary Outcomes (2)

  • knee range of motion (ROM)

    change from baseline to immediately pre treatment and from pre treatment to immediately post treatment

  • knee injury and osteoarthritis outcome score physical function short (KOOS-PS)

    change from baseline to immediately pre treatment and from pre treatment to immediately post treatment

Study Arms (3)

Shock wave(A)

EXPERIMENTAL

subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise

Device: radial extracorporeal shock waveOther: Exercise

Iontophoresis (B)

EXPERIMENTAL

subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise

Device: iontophoresisOther: Exercise

Control (C)

OTHER

stregnthening exercise;straight leg raising exercisein which the patients were positioned in the crook lying position with the unexercised limb was the flexed one then the patients were asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were don ,Isometric quadriceps contraction (quadriceps drill) in full knee extension maintained for 5 seconds, followed by a 5-second rest; the exercise was performed for 20 repetitions per session .treatment once per week for four weeks

Other: Exercise

Interventions

radial extracorporeal shock waveDEVICE

Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)

Shock wave(A)
iontophoresisDEVICE

Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):

Iontophoresis (B)
ExerciseOTHER

strengthening exercise

Control (C)Iontophoresis (B)Shock wave(A)

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology
  • Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .
  • Tenderness on medial tibial plateau
  • Intensity of pain: visual analogue scale equal to 5 or greater
  • Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)

You may not qualify if:

  • Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
  • Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee
  • history of previous knee surgery -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy ,Cairo University

Giza, 002, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

IontophoresisExercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 29, 2021

Study Start

January 20, 2021

Primary Completion

November 1, 2022

Study Completion

January 15, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

EG(1)