An interventional study of periosteal electrical dry needling with no maintenance treatments and periosteal electrical dry needling with maintenance treatments every other month in Knee Osteoarthritis, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 586 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)
Exclusion Criteria:
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periosteal electrical dry needling followed by no maintenance treatments
Other: periosteal electrical dry needling with no maintenance treatments
Periosteal electrical dry needling followed by maintenance treatments every other month
Other: periosteal electrical dry needling with maintenance treatments every other month
Periosteal electrical dry needling followed by monthly maintenance treatments
Other: periosteal electrical dry needling with monthly maintenance treatments
periosteal electrical dry needling
periosteal electrical dry needling with maintenance treatments every other month
periosteal electrical dry needling with monthly maintenance treatments
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
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Change in knee pain
Average Numeric Pain Rating Score. Higher score means greater pain
Time frame: 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
Time frame: 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
Time frame: baseline, 30 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in May 2024, 38 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 38 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Alabama Physical Therapy & Acupuncture