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

NCT ID: NCT03921749

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2020-05-20

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Focused shock wave

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 )

Group Type: EXPERIMENTAL

Shockwave

Intervention Type: 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.

Raidal shock wave

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)

Group Type: EXPERIMENTAL

Shockwave

Intervention Type: 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.

Interventions

Shockwave

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gwo-Chi Hu,PHD

Head of Physical Medicine and Rehbilitation, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwo Chi Hu

Role: PRINCIPAL_INVESTIGATOR

Taiwan Mackay Memorial Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Gwo Chi Gwo Chi Hu, PHD

Role: CONTACT

kung527@gmail.com

+886-2-2543-3535

Gwo Chi Hu

Role: CONTACT

Facility Contacts

Gwo Chi Hu

Role: primary

+886-2-2543-3535

References

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.

Reference Type: DERIVED

PMID: 35897371 (View on PubMed)

Other Identifiers

17MMHIS195

Identifier Type: -

Identifier Source: org_study_id