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Periosteal Electrical Dry Needling for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
Alabama Physical Therapy & Acupuncture
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult over the age of 18 years old:
  2. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months
  3. Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)

    1. Over 50 Years of age
    2. Less than 30 minutes of morning stiffness
    3. Crepitus on active motion
    4. Bony tenderness
    5. Bony enlargement
    6. No palpable warmth of Synovium

Exclusion Criteria:

  1. 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.
  2. History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
  3. History of a partial or total knee replacement on the painful lower extremity.
  4. History of a surgical procedure on either lower extremity in last 12 months.
  5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    1. Weakness involving a major muscle group of the lower extremity.
    2. Diminished patella or achilles tendon reflex
    3. Diminished or absent sensation to pinprick in lower extremity dermatome.
  6. Involvement in litigation or worker's compensation regarding knee pain.
  7. Any condition that might contraindicate the use of periosteal electric dry needling
  8. The patient is pregnant.

Sites / Locations

  • Team RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Periosteal electrical dry needling followed by no maintenance treatments

Periosteal electrical dry needling followed by maintenance treatments every other month

Periosteal electrical dry needling followed by monthly maintenance treatments

Arm Description

Periosteal electrical dry needling followed by no maintenance treatments

Periosteal electrical dry needling followed by maintenance treatments every other month

Periosteal electrical dry needling followed by monthly maintenance treatments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Change in knee pain
Average Numeric Pain Rating Score. Higher score means greater pain
Change in GROC (Global Rating of Change score)
GROC (ranges from -7 to +7). Global Rating of Change score
Change in Medication Intake (Frequency of medication intake during last time period)
Frequency of medication intake during last time period

Full Information

First Posted
April 13, 2022
Last Updated
September 1, 2023
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05365061
Brief Title
Periosteal Electrical Dry Needling for Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Periosteal electrical dry needling followed by no maintenance treatments
Arm Type
Experimental
Arm Description
Periosteal electrical dry needling followed by no maintenance treatments
Arm Title
Periosteal electrical dry needling followed by maintenance treatments every other month
Arm Type
Active Comparator
Arm Description
Periosteal electrical dry needling followed by maintenance treatments every other month
Arm Title
Periosteal electrical dry needling followed by monthly maintenance treatments
Arm Type
Active Comparator
Arm Description
Periosteal electrical dry needling followed by monthly maintenance treatments
Intervention Type
Other
Intervention Name(s)
periosteal electrical dry needling with no maintenance treatments
Intervention Description
periosteal electrical dry needling
Intervention Type
Other
Intervention Name(s)
periosteal electrical dry needling with maintenance treatments every other month
Intervention Description
periosteal electrical dry needling with maintenance treatments every other month
Intervention Type
Other
Intervention Name(s)
periosteal electrical dry needling with monthly maintenance treatments
Intervention Description
periosteal electrical dry needling with monthly maintenance treatments
Primary Outcome Measure Information:
Title
Change in WOMAC Knee Osteoarthritis Index (Total Score)
Description
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
Secondary Outcome Measure Information:
Title
Change in WOMAC Knee Osteoarthritis Index (Pain)
Description
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
Title
Change in WOMAC Knee Osteoarthritis Index (Stiffness)
Description
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
Title
Change in WOMAC Knee Osteoarthritis Index (Physical Function)
Description
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
Title
Change in knee pain
Description
Average Numeric Pain Rating Score. Higher score means greater pain
Time Frame
baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
Title
Change in GROC (Global Rating of Change score)
Description
GROC (ranges from -7 to +7). Global Rating of Change score
Time Frame
6 weeks, 14 weeks, 22 weeks, 30 weeks
Title
Change in Medication Intake (Frequency of medication intake during last time period)
Description
Frequency of medication intake during last time period
Time Frame
baseline, 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Bony tenderness Bony enlargement No palpable warmth of Synovium Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Dunning, PhD DPT
Phone
801-707-9056
Email
jamesdunning@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Butts, PhD DPT
Phone
803-422-3954
Email
buttsraymond@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, PhD DPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Team Rehabilitation
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Daisy, DPT

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Periosteal Electrical Dry Needling for Knee Osteoarthritis

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