NCT06181955

Brief Summary

The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

December 6, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Keywords

Physical therapyLower Extremity Functional Scale scoreUltrasound therapyExercisesQuadriceps

Outcome Measures

Primary Outcomes (1)

  • Lower Extremity Functional Scale (LEFS) score

    It is a measurement tool used to assess the functional status and ability of individuals with lower extremity musculoskeletal conditions or injuries. The LEFS consists of 20 items and each item is rated on a scale from 0 to 4, with 0 indicating extreme difficulty to perform the activity and 4 indicating no difficulty at all. The scores for all items are summed to obtain a total score ranging from 0 to 80.

    4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The participants in this group received Extracorporeal Shock Wave Therapy (ESWT) in addition to conventional physical therapy.

Other: Extracorporeal Shock Wave TherapyOther: conventional physical therapy

Control group

ACTIVE COMPARATOR

The participants in this group received conventional physical therapy only.

Other: conventional physical therapy

Interventions

The ESWT was performed by an ESWT instrument (Chattanooga) once a week for four consecutive weeks (a total of four sessions).

Experimental

Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.

Control groupExperimental

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score

You may not qualify if:

  • Secondary knee OA,
  • rheumatoid arthritis,
  • psoriatic arthritis,
  • the presence of any red flags (metastatic growth, thrombophlebitis),
  • neurologic or psychiatric impairments,
  • tissue injuries of the knee joint,
  • previous knee joint replacement or other surgeries in the knee joint,
  • already received ESWT,
  • Intra articular injection
  • unable to walk independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Masood Khan, MPTh

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group experimental-control design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 26, 2023

Study Start

December 6, 2021

Primary Completion

February 2, 2022

Study Completion

April 27, 2022

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations