Shock Waves in Knee Arthritis

NCT06833372 | Not Yet Recruiting

• 1 other identifier: SWinKA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.

Conditions

Arthritis of Knee

Keywords

shock waves; conservative treatment

Outcome Measures

Primary Outcomes (2)

• recovery of pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  From enrollment to 1, 3 and 6 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  questionnaire consisting of 24 questions addressing pain, stiffness and physical function. Score from 0 to 96, higher scores correspond to worse clinical condition.

  From enrollment to 1, 3 and 6 months

Secondary Outcomes (2)

• Roles and Maudsley Score

  At 1, 3 and 6 months

• MR image

  From enrollment to 6 months

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

only a daily exercise program for 4 weeks: passive and active assisted movement of the knee joint, hamstring stretching, and quadriceps strengthening exercises

Other: exercise group

ESWT group

EXPERIMENTAL

Shockwave therapy will be administered using an ESWT device (Minilith SL1, Storz) once a week for three consecutive weeks, for a total of three sessions. A focused shockwave modality with an electromagnetic device was chosen for the therapy.

Device: ESWT group

Interventions

ESWT group DEVICE

During each session, participants will receive 2000 pulses at a frequency of 4 Hz and an EDF between 0.02 and 0.2 mJ/mm2.

Also known as: shock waves therapy

ESWT group

exercise group OTHER

daily exercise program

Also known as: exercise

Exercise Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
• clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
• no history of physical therapy in the last 3 months,
• no infections, tumors in the treatment area of the knee,
• no pathology other than osteoarthritis that could cause knee pain,
• no pathology of the lumbar spine or hip that could refer knee pain,
• free from any condition that prevents participation in exercise or physical therapy willing to participate regularly in the treatment programs were included in the study.

You may not qualify if:

• inability to walk,
• a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
• evidence of a neurological disorder based on history or physical examination,
• generalized pain or fibromyalgia,
• secondary osteoarthritis (to metabolic or rheumatologic disease),
• administration of intra-articular injections (anesthetic, hyaluronic acid, cortisone) of the knee in the last 6 months,
• use of NSAIDs, paracetamol or topical agents in the previous week,
• a previous history of surgery involving the knee joint,
• contraindications to physical therapy (PM, epilepsy, neoplasia, coagulopathy, pregnancy).

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Policlinico di Bari

Bari, 70124, Italy

Location

Related Publications (3)

• Zhao Z, Ji H, Jing R, Liu C, Wang M, Zhai L, Bai X, Xing G. Extracorporeal shock-wave therapy reduces progression of knee osteoarthritis in rabbits by reducing nitric oxide level and chondrocyte apoptosis. Arch Orthop Trauma Surg. 2012 Nov;132(11):1547-53. doi: 10.1007/s00402-012-1586-4. Epub 2012 Jul 24.

  PMID: 22825641 BACKGROUND

• Ochiai N, Ohtori S, Sasho T, Nakagawa K, Takahashi K, Takahashi N, Murata R, Takahashi K, Moriya H, Wada Y, Saisu T. Extracorporeal shock wave therapy improves motor dysfunction and pain originating from knee osteoarthritis in rats. Osteoarthritis Cartilage. 2007 Sep;15(9):1093-6. doi: 10.1016/j.joca.2007.03.011. Epub 2007 Apr 26.

  PMID: 17466542 BACKGROUND

• Mostafa MSEM, Hamada HA, Kadry AM, Zahran SS, Helmy NA. Effect of High-Power Laser Therapy Versus Shock Wave Therapy on Pain and Function in Knee Osteoarthritis Patients: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):198-204. doi: 10.1089/photob.2021.0136. Epub 2022 Jan 5.

  PMID: 34986012 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Angela Notarnicola, M.D.Ph.D.

CONTACT

+39 0805592938; angelanotarnicola@yahoo.it

Ilaria Covelli, M.D.Ph.D.

CONTACT

+ 39 0805592938; ilariacovelli@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized clinical study

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)