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

NCT03921749 | Unknown

• 1 other identifier: 17MMHIS195
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Radial versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis : A Randomized Control Trial

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.

Secondary Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index

  (6MWT). The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.

• Lequesne index

  The evaluation will be done before therapy sections, 1 week after, 4weeks and 8 weeks and 6 months after 3rd section of therapy.

• Six-minute walk test (6MWT)

  The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy.

• Measurement of knee ROM

  The evaluation will be done before therapy sections, 1 week after and 8 weeks after 3rd section of therapy.

Study Arms (2)

Focused shock wave

EXPERIMENTAL

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 )

Device: Shockwave

Raidal shock wave

EXPERIMENTAL

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)

Device: Shockwave

Interventions

Shockwave DEVICE

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.

Focused shock wave; Raidal shock wave

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 35897371 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gwo Chi Hu

  Taiwan Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwo Chi Gwo Chi Hu, PHD

CONTACT

+886-2-2543-3535; kung527@gmail.com

Gwo Chi Hu

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Medicine and Rehbilitation, Associate Professor

Model Details: group A : focused shock wave, group B: focused shock wave

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 19, 2019
• Study Start: May 20, 2019
• Primary Completion: April 20, 2020
• Study Completion: May 20, 2020
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)