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Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shockwave
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • people aged 45 years or more
  • subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
  • subjects diagnosed with grade II or III OA during radiologicalexamination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
  • subjects with tenderness in the medial tibial plateau area
  • subjects who had pain on one side of the knee.

Exclusion Criteria:

  • patients with a history of spinal stenosis, evidence of neurologic disease by history or physical examination, or secondary causes of arthritis (inflammatory or metabolic)
  • those who had a surgical intervention or intra-articular injection in the affected knee in the previous 6 months
  • any contraindication to extracorporeal shock wave(pregnancy, cancer, coagulation disorders, inflammatory disease, pacemakers, or other electronic implants).

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Focused shock wave

Raidal shock wave

Arm Description

The extracorporeal shock wave will be applied to the patellofemoral and tibiofemoral borders and the subchondral bone of the medial tibia condyle of the affected knee joint. The intensities used will be focused shock wave therapy (0.20 mJ/mm 2 )

The extracorporeal shock wave will be applied to the patellofemoral and tibiofemoral borders and the subchondral bone of the medial tibia condyle of the affected knee joint. The intensities used will be radial shock wave therapy (3 bar)

Outcomes

Primary Outcome Measures

Visual Analogue Scale
The scores will be based on pain intensity, where 0 and 10 points represent an absence of pain and a maximal intensity level of pain, respectively.

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index
The WOMAC, a validated disease-specific self-reporting questionnaire, is an examination for evaluating OA symptoms. The index consists of five questions for severity of knee pain, two for stiffness, and 17 for limitations in physical function. The WOMAC score ranges from 0 (best) to 96 (worst), with high score representing worse symptom severity31.
Lequesne index
The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee.
Six-minute walk test (6MWT)
Mobility performance will be assessed with the Six-Minute Walk Test (6MWT). The 6MWT is a submaximal test of walking capacity.33 Participants will walk at a self- selected speed for 6 min on an indoor, 30 meter corridor or walkway with cones placed at the beginning and end of the 30 meter boundary to indicate turns, with the goal of traveling the maximum distance. Jogging and running will not be allowed.
Measurement of knee ROM
The assisted active ROM will be measured using a hand-held goniometry.Measurements of knee flexion and extension will be taken with patients lying supine on an examination couch. The fully extended knee is considered as the zero position, and the degrees of maximum flexion, maximum extension, and extension deficit, when present, will be recorded. A negative ROM score for extension indicated that the patient is unable to reach the zero position. The angle between maximum flexion and maximum extension will be described as the excursion range.

Full Information

First Posted
April 14, 2019
Last Updated
May 2, 2019
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03921749
Brief Title
Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
Official Title
Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis : A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2019 (Anticipated)
Primary Completion Date
April 20, 2020 (Anticipated)
Study Completion Date
May 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Radial versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis : A Randomized Control Trial
Detailed Description
Background Knee Osteoarthritis (OA) is the most prevalent of the chronic rheumatic diseases and is a leading cause of pain and disability in most countries worldwide. The treatment methods for knee OA are diverse for patients with mild or moderate osteoarthritis (OA). Biomechanical intervention, physical therapy and exercise, medication, and intra-articular injections (both corticosteroid and hyaluronic acid) are recommended. Recent studies have suggested that extracorporeal shock wave therapy is an effect treatment method for the knee OA. Based on the propagation pattern of the wave, extracorporeal shock wave therapy can be classified into two main modalities: focused and radial shock wave therapy. However, no previous study compared the effect of radial versus focused type of extracorporeal shock wave on symptoms and functions in patients with symptomatic knee OA. Therefore, the purpose of our study was to compare the effects of focused and radial shock wave therapy on patients with knee OA. Design: Randomized control trial Setting: Outpatient rehabilitation clinic in our hospital. Population:100 patients with mild and moderate knee OA Methods: Patients were randomly assigned to receive three sessions of either focused or radial shock wave therapy at 1-week intervals. The extracorporeal shock wave will be applied to the patellofemoral and tibiofemoral borders and the subchondral bone of the medial tibia condyle of the affected knee joint. The intensities that were used during focused shock wave therapy (0.20 mJ/mm 2 ) and radial shock wave therapy (3 bar) were comparable. The patients were evaluated at baseline and at 1, 4, and 8 weeks and 6 nmonths after the final shockwave treatment. The primary outcome measure was visual analogue scale. The secondary outcome measures were Western Ontario and McMaster Universities Osteoarthritis Index, the knee joint ROM, and sonographic findings and six-minute walk test (6MWT) will be performed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A : focused shock wave, group B: focused shock wave
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focused shock wave
Arm Type
Experimental
Arm Description
The extracorporeal shock wave will be applied to the patellofemoral and tibiofemoral borders and the subchondral bone of the medial tibia condyle of the affected knee joint. The intensities used will be focused shock wave therapy (0.20 mJ/mm 2 )
Arm Title
Raidal shock wave
Arm Type
Experimental
Arm Description
The extracorporeal shock wave will be applied to the patellofemoral and tibiofemoral borders and the subchondral bone of the medial tibia condyle of the affected knee joint. The intensities used will be radial shock wave therapy (3 bar)
Intervention Type
Device
Intervention Name(s)
Shockwave
Intervention Description
Both shockwave interventions will be administered without local anaesthesia. Three sessions will be administered at one-week intervals. During each session, 2000 pulses (1000 shots at the patellofemoral and tibiofemoral borders of the target knee and 1000 shots on the subchondral bone of the medial tibia condyle of the affected knee) will be delivered at 5 Hz. Energy flux density was 0.20 mJ/mm2 for patients in the "focused" group while "radial" shock waves were transmitted with 0.17 mJ/mm2 corresponding to a 3-bar energy level setting.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
The scores will be based on pain intensity, where 0 and 10 points represent an absence of pain and a maximal intensity level of pain, respectively.
Time Frame
The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
The WOMAC, a validated disease-specific self-reporting questionnaire, is an examination for evaluating OA symptoms. The index consists of five questions for severity of knee pain, two for stiffness, and 17 for limitations in physical function. The WOMAC score ranges from 0 (best) to 96 (worst), with high score representing worse symptom severity31.
Time Frame
(6MWT). The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.
Title
Lequesne index
Description
The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee.
Time Frame
The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.
Title
Six-minute walk test (6MWT)
Description
Mobility performance will be assessed with the Six-Minute Walk Test (6MWT). The 6MWT is a submaximal test of walking capacity.33 Participants will walk at a self- selected speed for 6 min on an indoor, 30 meter corridor or walkway with cones placed at the beginning and end of the 30 meter boundary to indicate turns, with the goal of traveling the maximum distance. Jogging and running will not be allowed.
Time Frame
The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy.
Title
Measurement of knee ROM
Description
The assisted active ROM will be measured using a hand-held goniometry.Measurements of knee flexion and extension will be taken with patients lying supine on an examination couch. The fully extended knee is considered as the zero position, and the degrees of maximum flexion, maximum extension, and extension deficit, when present, will be recorded. A negative ROM score for extension indicated that the patient is unable to reach the zero position. The angle between maximum flexion and maximum extension will be described as the excursion range.
Time Frame
The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: people aged 45 years or more subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology subjects diagnosed with grade II or III OA during radiologicalexamination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA subjects with tenderness in the medial tibial plateau area subjects who had pain on one side of the knee. Exclusion Criteria: patients with a history of spinal stenosis, evidence of neurologic disease by history or physical examination, or secondary causes of arthritis (inflammatory or metabolic) those who had a surgical intervention or intra-articular injection in the affected knee in the previous 6 months any contraindication to extracorporeal shock wave(pregnancy, cancer, coagulation disorders, inflammatory disease, pacemakers, or other electronic implants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwo Chi Gwo Chi Hu, PHD
Phone
+886-2-2543-3535
Email
kung527@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gwo Chi Hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwo Chi Hu
Organizational Affiliation
Taiwan Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwo Chi Hu
Phone
+886-2-2543-3535

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35897371
Citation
Ko NY, Chang CN, Cheng CH, Yu HK, Hu GC. Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Int J Environ Res Public Health. 2022 Jul 24;19(15):9001. doi: 10.3390/ijerph19159001.
Results Reference
derived

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Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

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