Knee OsteoarthritisNCT05365061
Periosteal Electrical Dry Needling for Knee Osteoarthritis
A study testing periosteal electrical dry needling with no maintenance treatments, periosteal electrical dry needling with maintenance treatments every other month and periosteal electrical dry needling with monthly maintenance treatments in people with Knee Osteoarthritis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial summary
The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- periosteal electrical dry needling with no maintenance treatments, periosteal electrical dry needling with maintenance treatments every other month and periosteal electrical dry needling with monthly maintenance treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over the age of 18 years old:
- Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months
- Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)
- Over 50 Years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
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- Bony tenderness
- Bony enlargement
- No palpable warmth of Synovium
Who cannot join
- Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
- History of a partial or total knee replacement on the painful lower extremity.
- History of a surgical procedure on either lower extremity in last 12 months.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Weakness involving a major muscle group of the lower extremity.
Show all 11Show fewer
- Diminished patella or achilles tendon reflex
- Diminished or absent sensation to pinprick in lower extremity dermatome.
- Involvement in litigation or worker's compensation regarding knee pain.
- Any condition that might contraindicate the use of periosteal electric dry needling
- The patient is pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periosteal Electrical Dry Needling With no Maintenance Treatments vs. Maintenance Treatments Every Other Month vs. Maintenance Treatments Once Per Month for Knee Osteoarthritis
The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. maintenance treatments, one maintenance treatment every other month, or one maintenance treatment per month) required to maintain improvements in pain and function following PEDN. Physical therapists commonly use PEDN to treat knee OA, and previous studies suggest that this treatment is useful for reducing pain and improving function in patients with osteoarthritis. However, an appropriate maintenance treatment strategy to maintain these outcomes is presently unknown.
Read the detailed description
Patients with knee osteoarthritis will be randomized to receive periosteal electrical dry needling 1-2 treatments per week for 6 weeks (up to 10 sessions total) followed by either: 1. no maintenance treatments, 2. one maintenance treatment every other month or 3. one maintenance treatment per month.
- Conditions
- Knee Osteoarthritis
- Being tested
- periosteal electrical dry needling with no maintenance treatments, periosteal electrical dry needling with maintenance treatments every other month, periosteal electrical dry needling with monthly maintenance treatments
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periosteal electrical dry needling with no maintenance treatmentsOther
periosteal electrical dry needling
periosteal electrical dry needling with maintenance treatments every other monthOther
periosteal electrical dry needling with maintenance treatments every other month
periosteal electrical dry needling with monthly maintenance treatmentsOther
periosteal electrical dry needling with monthly maintenance treatments
| Study group | Role | What they receive |
|---|---|---|
| Periosteal electrical dry needling followed by no maintenance treatments | Experimental | Periosteal electrical dry needling followed by no maintenance treatments Receives: Other: periosteal electrical dry needling with no maintenance treatments |
| Periosteal electrical dry needling followed by maintenance treatments every other month | Active comparator | Periosteal electrical dry needling followed by maintenance treatments every other month Receives: Other: periosteal electrical dry needling with maintenance treatments every other month |
| Periosteal electrical dry needling followed by monthly maintenance treatments | Active comparator | Periosteal electrical dry needling followed by monthly maintenance treatments Receives: Other: periosteal electrical dry needling with monthly maintenance treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Knee Osteoarthritis Index (Total Score)
24 questions each worth 0-4 points with maximum score of 96 points possible. The greater the score, the worse the symptoms of knee OA
Measured: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Secondary outcomes (6)
Change in WOMAC Knee Osteoarthritis Index (Pain)
5 questions each worth 0-4 points with maximum score of 20 points possible. The greater the score, the worse the pain.
Measured: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Stiffness)
2 questions each worth 0-4 points with maximum score of 8 points possible. The greater the score, the worse the stiffness.
Measured: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Physical Function)
17 questions each worth 0-4 points with maximum score of 68 points possible. The greater the score, the worse the physical function.
Measured: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in knee pain
Average Numeric Pain Rating Score. Higher score means greater pain
Measured: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in GROC (Global Rating of Change score)
GROC (ranges from -7 to +7). Global Rating of Change score
Measured: 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in Medication Intake (Frequency of medication intake during last time period)
Frequency of medication intake during last time period
Measured: baseline, 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Mar 2021
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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, Outcomes assessor
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, PhD DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365061
- Sponsor's protocol ID
- AAMT20231
- Status last verified
- Jun 2024
- First submitted
- 13 Apr 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dunning J, Young I, Taylor N, Mourad F, Bliton P, Butts R, Escaloni J, Gorby P, Varghese R, Maselli F, Fernandez-de-Las-Penas C. Effect of dose interval of periosteal and intraarticular electrical dry needling boosters on pain and disability in patients with knee osteoarthritis: a multi-center randomized clinical trial. Physiother Theory Pract. 2026 Mar;42(3):421-434. doi: 10.1080/09593985.2025.2575837. Epub 2025 Oct 17.
PubMed 41104706
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteal Electrical Dry Needling With no Maintenance Treatments vs. Maintenance Treatments Every Other Month vs. Maintenance Treatments Once Per Month for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05365061
- Acronym / sponsor ID
- AAMT20231
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 9 May 2022 (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.
The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. maintenance treatments, one maintenance treatment every other month, or one maintenance treatment per month) required to maintain improvements in pain and function following PEDN. Physical therapists commonly use PEDN to treat knee OA, and previous studies suggest that this treatment is useful for reducing pain and improving function in patients with osteoarthritis. However, an appropriate maintenance treatment strategy to maintain these outcomes is presently unknown.
Detailed description
Patients with knee osteoarthritis will be randomized to receive periosteal electrical dry needling 1-2 treatments per week for 6 weeks (up to 10 sessions total) followed by either: 1. no maintenance treatments, 2. one maintenance treatment every other month or 3. one maintenance treatment per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periosteal electrical dry needling followed by no maintenance treatments | Experimental | Other: periosteal electrical dry needling with no maintenance treatmentsPeriosteal electrical dry needling followed by no maintenance treatments |
| Periosteal electrical dry needling followed by maintenance treatments every other month | Active comparator | Other: periosteal electrical dry needling with maintenance treatments every other monthPeriosteal electrical dry needling followed by maintenance treatments every other month |
| Periosteal electrical dry needling followed by monthly maintenance treatments | Active comparator | Other: periosteal electrical dry needling with monthly maintenance treatmentsPeriosteal electrical dry needling followed by monthly maintenance treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult over the age of 18 years old:
- Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months
- Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)
Key exclusion criteria (11 listed)
- Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
- History of a partial or total knee replacement on the painful lower extremity.
- History of a surgical procedure on either lower extremity in last 12 months.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
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 |
|---|---|---|
| periosteal electrical dry needling with no maintenance treatmentsperiosteal electrical dry needling | Other | Periosteal electrical dry needling followed by no maintenance treatments |
| periosteal electrical dry needling with maintenance treatments every other monthperiosteal electrical dry needling with maintenance treatments every other month | Other | Periosteal electrical dry needling followed by maintenance treatments every other month |
| periosteal electrical dry needling with monthly maintenance treatmentsperiosteal electrical dry needling with monthly maintenance treatments | Other | Periosteal electrical dry needling followed by monthly maintenance treatments |
Primary outcome
Change in WOMAC Knee Osteoarthritis Index (Total Score)
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
24 questions each worth 0-4 points with maximum score of 96 points possible. The greater the score, the worse the symptoms of knee OA
6 secondary outcomes
Change in WOMAC Knee Osteoarthritis Index (Pain)
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Stiffness)
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in WOMAC Knee Osteoarthritis Index (Physical Function)
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in knee pain
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in GROC (Global Rating of Change score)
Time frame: 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in Medication Intake (Frequency of medication intake during last time period)
Time frame: baseline, 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 41104706Dunning J, Young I, Taylor N, Mourad F, Bliton P, Butts R, Escaloni J, Gorby P, Varghese R, Maselli F, Fernandez-de-Las-Penas C. Effect of dose interval of periosteal and intraarticular electrical dry needling boosters on pain and disability in patients with knee osteoarthritis: a multi-center randomized clinical trial. Physiother Theory Pract. 2026 Mar;42(3):421-434. doi: 10.1080/09593985.2025.2575837. Epub 2025 Oct 17.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
James Dunning, PhD DPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periosteal electrical dry needling with no maintenance treatments, periosteal electrical dry needling with maintenance treatments every other month and periosteal electrical dry needling with monthly maintenance treatments in people with Knee Osteoarthritis, run by Alabama Physical Therapy & Acupuncture 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC Knee Osteoarthritis Index (Total Score) (time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 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 NCT05365061, which also lists 1 linked publication.
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 12 Jun 2024.