Knee OsteoarthritisNCT02373631
Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis
A study testing Dry Needling, Conventional PT and Conventional PT 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 compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). 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?
- Dry Needling, Conventional PT and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 19 May 2017
- 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
- 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)
- 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
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 previous surgery to the knee
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
- History of a surgical procedure on either lower extremity in last 6 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 electro-needling
- The patient is pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117
About this study
Official title: Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial
The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.
Read the detailed description
Patients with knee OA will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1) Dry Needling and conventional physical therapy or the (2) Conventional physical therapy (manual physical therapy, exercise, range of motion and stretching)
- Conditions
- Knee Osteoarthritis
- Being tested
- Dry Needling, Conventional PT, Conventional PT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Needling, Conventional PTOther
Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)
Conventional PTOther
Conventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total)
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling, Conventional PT | Experimental | Not described Receives: Other: Dry Needling, Conventional PT |
| Conventional PT | Active comparator | Not described Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain Intensity (NPRS)
Measured: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Pain)
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Measured: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Stiffness)
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Measured: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Physical Function)
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Measured: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Total)
24 Questions each worth 0-4 points with a maximum score of 96 points possible
Measured: Baseline, 2 Weeks, 6 Weeks, 3 Months
Secondary outcomes (2)
Change in Global Rating of Change Score (GROC)
Measured: 2 Weeks, 6 Weeks, 3 Months
Change in Medicine Intake (Frequency of medication intake)
Frequency of medication intake (narcotics and over-the-counter) for knee pain
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion19 May 2017
- Study completion19 May 2017
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
- 105 participants (estimated)
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, DPT FAAOMPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373631
- Sponsor's protocol ID
- AAMT0003
- Status last verified
- May 2017
- First submitted
- 10 Feb 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
PubMed 29864043
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02373631
- Acronym / sponsor ID
- AAMT0003
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- Feb 2015
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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 compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.
Detailed description
Patients with knee OA will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1) Dry Needling and conventional physical therapy or the (2) Conventional physical therapy (manual physical therapy, exercise, range of motion and stretching)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling, Conventional PT | Experimental | Other: Dry Needling, Conventional PT |
| Conventional PT | Active comparator | Other: Conventional PT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
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 previous surgery to the knee
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
- History of a surgical procedure on either lower extremity in last 6 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 |
|---|---|---|
| Dry Needling, Conventional PTDry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total) | Other | Dry Needling, Conventional PT |
| Conventional PTConventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total) | Other | Conventional PT |
Primary outcome
Change in Knee Pain Intensity (NPRS)
Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Pain)
Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Change in Knee Osteoarthritis Index (Stiffness)
Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Change in Knee Osteoarthritis Index (Physical Function)
Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Change in Knee Osteoarthritis Index (Total)
Time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months
24 Questions each worth 0-4 points with a maximum score of 96 points possible
2 secondary outcomes
Change in Global Rating of Change Score (GROC)
Time frame: 2 Weeks, 6 Weeks, 3 Months
Change in Medicine Intake (Frequency of medication intake)
Time frame: Baseline, 3 months
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 23 May 2017.
- Derived from this study: PubMed 29864043Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
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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, DPT FAAOMPT 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 Dry Needling, Conventional PT and Conventional PT 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 8 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 23 May 2017. 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 Knee Pain Intensity (NPRS) (time frame: Baseline, 2 Weeks, 6 Weeks, 3 Months). The study lists 5 primary outcomes in all. 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 NCT02373631, 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 23 May 2017.