Trial Outcomes & Findings for Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis. (NCT NCT06622512)
NCT ID: NCT06622512
Last Updated: 2026-05-15
Results Overview
Pain intensity was assessed using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Data correspond to the 4-month follow-up assessment.
COMPLETED
NA
82 participants
Baseline and 4 months after the first session (final follow-up assessment).
2026-05-15
Participant Flow
Screening and eligibility assessment took place from February 1, 2024, to September 30, 2024, at a single academic medical center specializing in physical and rehabilitation medicine. Eligible participants were identified through outpatient clinics and referrals from orthopedic and rehabilitation specialists. Enrollment and randomization began on August 1, 2024.
Screening began in February 2024. The first participant was enrolled and randomized on August 1, 2024, which corresponds to the Study Start Date in the Protocol Section. A total of 82 participants were enrolled and randomized into three treatment groups (28, 28, and 26 participants). Eleven participants did not complete the 4-month follow-up, primarily due to loss to follow-up (n=9) or withdrawal of consent (n=2). 71 participants completed the study and were included in the final analyses.
Participant milestones
| Measure |
Medial Line Group
Participants received radial pressure wave therapy (RPWT) applied exclusively to the medial interarticular line of the knee. Each session delivered 2,000 impulses using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
Pain-Site Guided Group
Participants received radial pressure wave therapy (RPWT) applied to the two most painful knee sites identified by clinical palpation. Each session delivered 2,000 impulses (1,000 per site) using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
Medial and Lateral Lines Group
Participants received radial pressure wave therapy (RPWT) applied to both the medial and lateral interarticular lines of the knee. Each session delivered 2,000 impulses total (1,000 per site) using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
26
|
|
Overall Study
COMPLETED
|
23
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Medial Line Group
Participants received radial pressure wave therapy (RPWT) applied exclusively to the medial interarticular line of the knee. Each session delivered 2,000 impulses using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
Pain-Site Guided Group
Participants received radial pressure wave therapy (RPWT) applied to the two most painful knee sites identified by clinical palpation. Each session delivered 2,000 impulses (1,000 per site) using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
Medial and Lateral Lines Group
Participants received radial pressure wave therapy (RPWT) applied to both the medial and lateral interarticular lines of the knee. Each session delivered 2,000 impulses total (1,000 per site) using the BTL-6000 device at 2.0 bar and 10 Hz. Treatment was administered once weekly for 3 weeks. After treatment, participants followed a standardized 4-week home-based rehabilitation program.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pain-Site Guided Group
n=28 Participants
Participants in this group received radial pressure wave therapy (RPWT) applied to the two most painful points identified by clinical palpation. Each session delivered 2,000 impulses (1,000 at each point) using the BTL-6000 device at 2.0 bar and 10 Hz. A total of three weekly sessions were conducted. After the intervention, participants followed a 4-week home-based rehabilitation program including superficial thermotherapy, stretching, strengthening, and proprioceptive exercises.
|
Medial Line Group
n=28 Participants
Participants in this group received RPWT applied exclusively to the medial interarticular line of the knee. Each session involved 2,000 impulses at 2.0 bar and 10 Hz, using the BTL-6000 device. The intervention consisted of three sessions (one per week). Participants also followed a standardized 4-week home-based rehabilitation program comprising thermotherapy, stretching, strengthening, and proprioceptive exercises.
Radial Pressure Wave Therapy: Radial pressure wave therapy (RPWT) is a non-invasive treatment used for musculoskeletal disorders, including knee OA. (Schroeder AN) It involves the application of mechanical energy to stimulate biological responses, RPWT differs fundamentally from focal shock wave therapy (FSWT) in several physical properties, in its point of maximum energy flux density (EFD), and in some clinical applications. RPWT activates cellular pathways involved in tissue regeneration and generates mechanical energy that spreads radially from the point of application, primarily affecting superficial tissues and leading to pain relief and improved function through a process known as mechano-transduction, by enhancing blood flow and stimulating cellular repair processes . (Simplicio CL, Wang CJ)
|
Medial and Lateral Lines Group
n=26 Participants
This group received RPWT applied to both the medial and lateral interarticular lines of the knee. Each session involved 1,000 impulses at each site (2,000 total), using the BTL-6000 device at 2.0 bar and 10 Hz. The intervention consisted of three weekly sessions. A 4-week home-based rehabilitation program was also implemented, including thermotherapy, muscle strengthening, flexibility, and proprioceptive training.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.92 Years
STANDARD_DEVIATION 8.17 • n=28 Participants
|
65.61 Years
STANDARD_DEVIATION 7.71 • n=28 Participants
|
65.31 Years
STANDARD_DEVIATION 8.38 • n=26 Participants
|
65.26 Years
STANDARD_DEVIATION 8.03 • n=82 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=28 Participants
|
20 Participants
n=28 Participants
|
18 Participants
n=26 Participants
|
57 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=28 Participants
|
8 Participants
n=28 Participants
|
8 Participants
n=26 Participants
|
25 Participants
n=82 Participants
|
|
Region of Enrollment
Mexico
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
26 Participants
n=26 Participants
|
82 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline and 4 months after the first session (final follow-up assessment).Population: Analysis included participants who completed the 4-month follow-up assessment. Missing data were handled by complete-case analysis.
Pain intensity was assessed using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Data correspond to the 4-month follow-up assessment.
Outcome measures
| Measure |
Medial Line Group
n=23 Participants
Participants in this group received RPWT applied exclusively to the medial interarticular line of the knee. Each session involved 2,000 impulses at 2.0 bar and 10 Hz, using the BTL-6000 device. The intervention consisted of three sessions (one per week). Participants also followed a standardized 4-week home-based rehabilitation program comprising thermotherapy, stretching, strengthening, and proprioceptive exercises.
|
Medial and Lateral Lines Group
n=22 Participants
This group received RPWT applied to both the medial and lateral interarticular lines of the knee. Each session involved 1,000 impulses at each site (2,000 total), using the BTL-6000 device at 2.0 bar and 10 Hz. The intervention consisted of three weekly sessions. A 4-week home-based rehabilitation program was also implemented, including thermotherapy, muscle strengthening, flexibility, and proprioceptive training.
|
Pain-Site Guided Group
n=26 Participants
Participants in this group received radial pressure wave therapy (RPWT) applied to the two most painful points identified by clinical palpation. Each session delivered 2,000 impulses (1,000 at each point) using the BTL-6000 device at 2.0 bar and 10 Hz. A total of three weekly sessions were conducted. After the intervention, participants followed a 4-week home-based rehabilitation program including superficial thermotherapy, stretching, strengthening, and proprioceptive exercises.
|
|---|---|---|---|
|
Pain Intensity
|
4.52 Score (0-10)
Standard Deviation 2.52
|
5.73 Score (0-10)
Standard Deviation 2.64
|
4.81 Score (0-10)
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: Four months after the first session (final follow-up assessment).Self-reported disability measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a disease-specific, self-administered questionnaire designed for patients with knee osteoarthritis. It consists of 24 items grouped into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The Likert version was used, with five response levels for each item (none, mild, moderate, severe, or extreme), scored from 0 to 4. The total score is obtained by summing all item scores, with higher values indicating greater disability. Scores were standardized to a 0-100 scale, where 0 represents the best possible health status and 100 the worst. WOMAC was assessed at baseline, after treatment, and at 2- and 4-month follow-ups. The data reported correspond to the final 4-month assessment, representing the main time point for analysis.
Outcome measures
| Measure |
Medial Line Group
n=23 Participants
Participants in this group received RPWT applied exclusively to the medial interarticular line of the knee. Each session involved 2,000 impulses at 2.0 bar and 10 Hz, using the BTL-6000 device. The intervention consisted of three sessions (one per week). Participants also followed a standardized 4-week home-based rehabilitation program comprising thermotherapy, stretching, strengthening, and proprioceptive exercises.
|
Medial and Lateral Lines Group
n=22 Participants
This group received RPWT applied to both the medial and lateral interarticular lines of the knee. Each session involved 1,000 impulses at each site (2,000 total), using the BTL-6000 device at 2.0 bar and 10 Hz. The intervention consisted of three weekly sessions. A 4-week home-based rehabilitation program was also implemented, including thermotherapy, muscle strengthening, flexibility, and proprioceptive training.
|
Pain-Site Guided Group
n=26 Participants
Participants in this group received radial pressure wave therapy (RPWT) applied to the two most painful points identified by clinical palpation. Each session delivered 2,000 impulses (1,000 at each point) using the BTL-6000 device at 2.0 bar and 10 Hz. A total of three weekly sessions were conducted. After the intervention, participants followed a 4-week home-based rehabilitation program including superficial thermotherapy, stretching, strengthening, and proprioceptive exercises.
|
|---|---|---|---|
|
Self-reported Disability
|
30.26 Scores on a scale (0-100).
Standard Deviation 19.29
|
40.05 Scores on a scale (0-100).
Standard Deviation 23.69
|
32.19 Scores on a scale (0-100).
Standard Deviation 17.45
|
Adverse Events
Pain-Site Guided Group
Medial Line Group
Medial and Lateral Lines Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Armando Tonatiuh Ávila García.
Hospital Civil de Guadalajara "Fray Antonio Alcalde" - Department of Physical Medicine and Rehabilitation.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place