Knee OsteoarthristisNCT07567365
Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients With Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study
A study testing Physical Rehab and Focused Shockwave Therapy in people with Knee Osteoarthristis, run by Pulse Wave USA at 1 site in United States.
Trial summary
Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Physical Rehab and Focused Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2027to 25 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have diagnosed OA of the unilateral or bilateral knee(s) sufficient to qualify as grade I, II, or III O.A.
Who cannot join
- Patients without diagnosable or gradable O.A. of the knee or knees.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Westminster Spine & Injury Center
Westminster, Colorado, 80021
CAMERON HALL, 3034259557, drhall@pulse-wave.us
About this study
Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study
- Conditions
- Knee Osteoarthristis
- Being tested
- Physical Rehab, Focused Shockwave Therapy
- Keywords
- Knee Osteoarthritis, Focused Shockwave, Pulse Wave
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical RehabOther
Also called Physical Therapy
Physical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement.
Focused Shockwave TherapyDevice
Applying focused shockwave therapy using a focused shockwave therapy device to the treatment area.
| Study group | Role | What they receive |
|---|---|---|
| Physical Rehab Group | Active comparator | Participants in this arm will receive physical rehab only for at the same frequency and duration as the comparator group. Receives: Other: Physical Rehab |
| Focused Shockwave Therapy Group | Active comparator | This arm will receive focused shockwave therapy at the same frequency and duration as the comparator group. Receives: Device: Focused Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins.
The primary outcome measure will be the between-group difference in change from baseline in WOMAC Pain Subscale score at 12 weeks.
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start25 Sep 2027 (estimated)
- Primary completion25 Jun 2028 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Wave USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cameron Hall, Pulse Wave USA
- Investigators
- Cameron A Hall, DC, PhD, Principal investigator, Pulse Wave USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567365
- Sponsor's protocol ID
- IKOABS1
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patient privacy and HIPAA.
Publications
Avendano-Coy J, Comino-Suarez N, Grande-Munoz J, Avendano-Lopez C, Gomez-Soriano J. Extracorporeal shockwave therapy improves pain and function in subjects with knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2020 Oct;82:64-75. doi: 10.1016/j.ijsu.2020.07.055. Epub 2020 Aug 13.
PubMed 32798759Covelli I, De Giorgi S, Di Lorenzo A, Pavone A, Salvato F, Rifino F, Moretti B, Solarino G, Notarnicola A. Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months. Life (Basel). 2024 Nov 8;14(11):1453. doi: 10.3390/life14111453.
PubMed 39598251Liao PC, Chou SH, Shih CL. A systematic review of the use of shockwave therapy for knee osteoarthritis. J Orthop. 2024 May 1;56:18-25. doi: 10.1016/j.jor.2024.04.020. eCollection 2024 Oct.
PubMed 38765896Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.
PubMed 32215674
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients With Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study
- ClinicalTrials.gov ID
- NCT07567365
- Acronym / sponsor ID
- IKOABS1
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee Osteoarthritis, Focused Shockwave, Pulse Wave
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pulse Wave USAIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2027 (estimated)
- Primary completion
- 25 Jun 2028 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Rehab Group | Active comparator | Other: Physical RehabParticipants in this arm will receive physical rehab only for at the same frequency and duration as the comparator group. |
| Focused Shockwave Therapy Group | Active comparator | Device: Focused Shockwave TherapyThis arm will receive focused shockwave therapy at the same frequency and duration as the comparator group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient must have diagnosed OA of the unilateral or bilateral knee(s) sufficient to qualify as grade I, II, or III O.A.
Key exclusion criteria (1 listed)
- Patients without diagnosable or gradable O.A. of the knee or knees.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical RehabAlso: Physical TherapyPhysical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement. | Other | Physical Rehab Group |
| Focused Shockwave TherapyApplying focused shockwave therapy using a focused shockwave therapy device to the treatment area. | Device | Focused Shockwave Therapy Group |
Primary outcome
Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins.
Time frame: 8 to 12 weeks
The primary outcome measure will be the between-group difference in change from baseline in WOMAC Pain Subscale score at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 32798759Avendano-Coy J, Comino-Suarez N, Grande-Munoz J, Avendano-Lopez C, Gomez-Soriano J. Extracorporeal shockwave therapy improves pain and function in subjects with knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2020 Oct;82:64-75. doi: 10.1016/j.ijsu.2020.07.055. Epub 2020 Aug 13.
- Background: PubMed 39598251Covelli I, De Giorgi S, Di Lorenzo A, Pavone A, Salvato F, Rifino F, Moretti B, Solarino G, Notarnicola A. Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months. Life (Basel). 2024 Nov 8;14(11):1453. doi: 10.3390/life14111453.
- Background: PubMed 38765896Liao PC, Chou SH, Shih CL. A systematic review of the use of shockwave therapy for knee osteoarthritis. J Orthop. 2024 May 1;56:18-25. doi: 10.1016/j.jor.2024.04.020. eCollection 2024 Oct.
- Background: PubMed 32215674Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.
- Individual participant dataSharing planned: No. Patient privacy and HIPAA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cameron A Hall, DC, PhD principal investigator
Pulse Wave USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Rehab and Focused Shockwave Therapy in people with Knee Osteoarthristis, run by Pulse Wave USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron A Hall, DC, PhD (720-518-8005, drhall@pulse-wave.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins. (time frame: 8 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567365, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.