Comparison of the Pain and Functional Improvement of Combined Extracorporeal Shockwave Therapy With or Without Intra-articular Hyaluronic Acid and Platelet-rich Plasma Injection on Advanced Osteoarthritis of the Knees.

NCT07819955 | Completed DMC

• 2 other identifiers: 202201536A3NSTC112-2314-B-182A-014
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single group, double-blind, randomized clinical trial that enrolled 48 patients with Kellgren-Lawrence grade II to IV osteoarthritis of the knee. Patients were randomly assigned to three groups: Saline + ESWT (S+E group), High Platelet-Rich Plasma (PRP + ESWT (P+E group), and Hyaluronic Acid + ESWT (HA + ESWT (H+E group). All patients were followed for one year. Assessments included the Visual Analogue Scale (VAS), serum enzyme-linked immunosorbent assay (ELISA), knee X-ray and ultrasound examinations, and functional scores (WOMAC, KOOS, and IKDC).

Conditions

Osteoarthritis (OA)

Keywords

Osteoarthritis; Hyaluronic Acid; Platelet-Rich Plasma; Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (4)

• VAS（Visual Analogue Scale）

  VAS（Visual Analogue Scale）：Ask the patient to mark the degree of their pain on a 10 cm line, from "no pain" on the far left to "unbearable pain" on the far right. The "Numerical Rating Scale" uses a numerical concept of 0-10 points to express the degree of pain, from no pain (0 points) to very painful (10 points).

  Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.

• WOMAC(Western Ontario and McMaster Universities Arthritis Index)

  WOMAC is a standardized questionnaire specifically designed to assess the symptoms and functional status of osteoarthritis (degenerative joint disease) of the knee and hip. WOMAC contains 24 items, divided into three categories. Pain (5 items): Assess the degree of pain when walking, climbing stairs, lying down, sitting, or standing. Score range: 0 to 20. Stiffness (2 items): Assess the feeling of stiffness in the joints upon waking in the morning and after resting during the day. Score range: 0 to 8. Physical Function (17 items): Assess the difficulty of performing daily activities such as climbing stairs, getting up, bending over, walking, putting on socks, and doing housework. Score range: 0 to 68.The Likert scale was used for scoring：0 for none, 1 for mild, 2 for moderate, 3 for severe, and 4 for very severe. Total score: The sum of the three scores ranges from 0 to 96. A higher score indicates more severe arthritis symptoms and greater functional impairment.

  Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.

• KOOS scale (Knee Injury and Osteoarthritis Outcome Score)

  The KOOS scaleis a standardized questionnaire used to assess the subjective symptoms and quality of life of patients with knee injuries and osteoarthritis. KOOS contains 42 items, independently assessing the following five subscales: 1. Pain: Assessing the frequency and severity of knee pain. 2. Other symptoms: Including swelling, clicking, limited extension or flexion, etc. 3. Daily Living Functions : Ease of performing everyday actions such as going down stairs, sitting down, and putting on socks. 4. Sport/Rec: Performance in activities such as running, jumping, kneeling, or squatting.5. Quality of Life : The psychological impact and distress caused by knee condition on daily life. Scoring Method: Each item is scored on a Likert scale from 0 to 4. Score Range: Each of the five categories is calculated independently and converted to a percentage scale from 0 to 100. Score Meaning: 0 represents the worst knee condition, extremely severe; 100 represents no symptoms and excellent knee

  Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.

• IKDC (International Knee Documentation Committee Subjective Knee Form)

  IKDC is suitable for patients with various knee joint conditions (such as ligament injuries, meniscus tears, cartilage problems, or osteoarthritis), and is particularly commonly used for sports injuries and post-operative follow-up. It covers three main categories: symptoms (pain, stiffness, swelling, locking, or weakness. Assess three core symptom categories: assess frequency and severity of pain, stiffness, swelling, joint locking, or knee displacement. Assess sports and activities: assess limitations in daily activities (such as climbing stairs, standing up from a chair, squatting) and during movement or jumping. Assess current overall knee function: the patient's rating of their current knee condition compared to before the injury. Scoring and Interpretation: Score range: 0 to 100. Meaning: Higher scores indicate better function and fewer symptoms; 100 points indicates no symptoms and no limitations in daily life or sports.

  Functional assessments were performed at months 0, 3, 6, 9, and 12 of the treatment course.

Secondary Outcomes (1)

• Enzyme-Linked Immunosorbent Assay

  Functional assessments were performed at months 0, 6, and 12 of the treatment course.

Other Outcomes (6)

• Ultrasound Assessment: Joint Effusion

  Functional assessments are performed at months 0, 6, and 12 of treatment.

• Ultrasound Assessment: Medial Meniscus (MM) Extrusions Width at Full Extension

  Functional assessments were performed at months 0, 6, and 12 of the treatment course.

• Ultrasound Assessment: Medial Meniscus (MM) Extrusion Width at Standing Weight-Bearing

  Functional assessments were performed at months 0, 6, and 12 of the treatment course.

Study Arms (3)

ESWT+normal saline

PLACEBO COMPARATOR

Each group received ESWT treatment and an injection of Saline as a placebo to prevent participants from knowing they were in the control group.

Device: Extracorporeal Shock Wave Therapy; Drug: Normal Saline

ESWT+Hyaluronic Acid(HA)

EXPERIMENTAL

This group of patients will receive ESWT and HA injections.

Device: Extracorporeal Shock Wave Therapy; Drug: Hyaluronic Acid (HA)

ESWT+Platelet-Rich Plasma(PRP)

EXPERIMENTAL

This group of patients will receive ESWT and PRP injections.

Device: Extracorporeal Shock Wave Therapy; Biological: Platelet-Rich Plasma

Interventions

Extracorporeal Shock Wave Therapy DEVICE

Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive, injection-free, and radiation-free treatment method commonly used to treat musculoskeletal disorders. Compared to conventional instrument-based treatments, it can reach deeper tissues. Shock waves can cause microscopic damage to injured or poorly healed tissues, promoting tissue repair, angiogenesis, and pain relief. Using a Storz Medical shockwave therapy machine at an energy of 0.25 mJ/mm², 4000 shocks were administered each time, followed by three treatments at two-week intervals.

ESWT+Hyaluronic Acid(HA); ESWT+Platelet-Rich Plasma(PRP); ESWT+normal saline

Normal Saline DRUG

Physiological saline solution is a mixture of sodium chloride (salt) and water, with a concentration of 0.9%, and its osmotic pressure is equal to that of human body fluids. Because sterile physiological saline solution has a simple composition and its osmotic pressure is similar to that of the human body and it has no pharmacological activity, it is often used as a sham treatment control group.

ESWT+normal saline

Hyaluronic Acid (HA) DRUG

Hyaluronic acid (also known as hyaluronic acid) is a biological polysaccharide with high water absorption and viscoelasticity. It is a component of the articular cartilage matrix and one of the main components of joint lubricating fluid. Hyaluronic acid in the joint cavity can help joints move smoothly, cushion impacts, and reduce wear and tear between articular cartilage.

ESWT+Hyaluronic Acid(HA)

Platelet-Rich Plasma BIOLOGICAL

PRP therapy mainly involves drawing the patient's own blood, centrifuging it at high speed through a special extraction tube to separate platelets, and then injecting the concentrated platelets into the joint cavity. Utilizing the repair and regeneration capabilities of the growth factors abundant in the platelet vesicles, it repairs the worn-out meniscus cartilage, promotes tissue regeneration, and relieves the pain of degenerative knee osteoarthritis.

ESWT+Platelet-Rich Plasma(PRP)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 years and older with phase II, III, or IV osteoarthritis of the knee. The phase of osteoarthritis of the knee is defined according to the Kellgren-Lawrence classification; phase II: Only slight narrowing of the joint cavity, with visible bone spurs.
• phase III: Numerous bone spurs, significant narrowing of the joint cavity, and subchondral cysts visible in the subchondral bone.
• phase IV: Larger and more prominent bone spurs, severe narrowing of the joint cavity, sclerosis of the subchondral bone, and even joint deformities.

You may not qualify if:

• Pregnant or breastfeeding women.
• Patients with arrhythmia or those with pacemakers.
• Patients with tumors.
• Individuals with coagulation disorders.
• Patients with chronic renal failure (glomerular filtration rate \< 60).
• Patients with known allergies to hyaluronic acid, or those with infections or skin diseases.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung, 833401, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Extracorporeal Shockwave Therapy; Saline Solution; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

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

Model Details: Each group will receive ESWT treatment and be injected with different reagents. 1. ESWT+saline 2. ESWT+HA 3. ESWT+PRP

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 15, 2026
• Study Start: August 4, 2023
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: September 15, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)