Knee OsteoarthritisNCT05374330
Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist
A study testing Electroacupuncture in people with Knee Osteoarthritis, run by University of Manitoba at 1 site in Canada.
Trial summary
A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Dec 2023
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
Who cannot join
- Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
- Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.
- Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.
- Other: allergy to needle components, needle phobia, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Electroacupuncture (EA) to Affect Pain, Function and Quality of Life in Patients With End Stage Knee Osteoarthritis (KOA) on a Total Knee Arthroplasty (TKA) Waitlist
A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.
Read the detailed description
The purpose of this study is to determine the efficacy of EA as a treatment strategy in the end stage knee osteoarthritis (KOA) population waiting for total knee arthroplasty (TKA). The research objectives are to 1. To determine the efficacy of EA to provide pain relief, improve function and quality of life in the end stage KOA population who are waiting for TKA. 2. To determine if EA is superior to sham EA or waiting list groups in providing pain relief, improving function and quality of life in the end stage KOA population who are waiting for TKA.
Outcome measures will be collected from all 3 groups at baseline, mid point, completion and 6 week follow up.
Participants will be recruited from the Concordia Joint Replacement Group in Winnipeg, Manitoba.
Inclusion Criteria: participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
Exclusion Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.
Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.
Other: allergy to needle components, needle phobia, pregnancy
- Conditions
- Knee Osteoarthritis
- Being tested
- Electroacupuncture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Also called Electrical acupuncture
Acupuncture needles are inserted into the body at standardized acupuncture points. An electrical current is then applied to 4 needles through 2 channels of electrical current. The sham group receives the same protocol with sham needles and sham electrical current.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Acupuncture needles will be inserted into the body at standardized acupuncture points. Electrical current will then be applied using 2 channels of electrical current for a total of 4 points receiving electroacupuncture Receives: Other: Electroacupuncture |
| Sham acupuncture | Sham comparator | Sham Acupuncture needles will be placed at standardized acupuncture points. Sham electrical current will then be applied using 2 channels / 4 points as in the electroacupuncture group. The electrical current will not be turned on. Receives: Other: Electroacupuncture |
| Waitlist | No intervention | The wait list group will be required to complete questionnaires at 4 separate time points over the 12 week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Disease specific outcome measure. Measuring change in disease specific function over 4 time points (as noted below). The WOMAC provides a multidimensional assessment inclusive of activities of daily life (ADL's), functional mobility, gait, general health, and quality of life organized into 3 subscales (pain, stiffness, physical function) consisting of 24 items scored on a 5-point scale from 0-4. Higher scores represent higher pain values or worse function for a total possible score of 96.
Measured: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Secondary outcomes (3)
The Short Form-Survey 36 (SF-36)
Quality of life outcome measure. Measuring change in health related QOL over 4 time points (as noted below). The SF-36 includes 36 items which cover 8 health domains: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, and general health perceptions. A total score can be used to indicate low or high HRQoL, while the physical component summary and the mental component summary can be used to rate these 2 separate dimensions of HRQoL.
Measured: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
The Short Form McGill Pain Questionnaire (SF-MPQ)
Pain outcome measure. measuring change in pain over 4 time points (as noted below). Using a 5-point pain intensity scale, there are 4 subscales with a total of 78 pain descriptor items and a single item pain intensity scale.
Measured: Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion
Numeric Pain Rating Scale (NPRS)
Pain outcome measure: measuring change in pain over 4 time points (as noted below). The NPRS measures pain on a 0-10 point scale with 0 being no pain and 10 being the most severe pain.
Measured: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janine Didyk, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374330
- Sponsor's protocol ID
- H2022:100
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undetermined at this time
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electroacupuncture (EA) to Affect Pain, Function and Quality of Life in Patients With End Stage Knee Osteoarthritis (KOA) on a Total Knee Arthroplasty (TKA) Waitlist
- ClinicalTrials.gov ID
- NCT05374330
- Acronym / sponsor ID
- H2022:100
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 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.
A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.
Detailed description
The purpose of this study is to determine the efficacy of EA as a treatment strategy in the end stage knee osteoarthritis (KOA) population waiting for total knee arthroplasty (TKA). The research objectives are to 1. To determine the efficacy of EA to provide pain relief, improve function and quality of life in the end stage KOA population who are waiting for TKA. 2. To determine if EA is superior to sham EA or waiting list groups in providing pain relief, improving function and quality of life in the end stage KOA population who are waiting for TKA.
Outcome measures will be collected from all 3 groups at baseline, mid point, completion and 6 week follow up.
Participants will be recruited from the Concordia Joint Replacement Group in Winnipeg, Manitoba.
Inclusion Criteria: participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
Exclusion Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.
Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.
Other: allergy to needle components, needle phobia, pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Other: ElectroacupunctureAcupuncture needles will be inserted into the body at standardized acupuncture points. Electrical current will then be applied using 2 channels of electrical current for a total of 4 points receiving electroacupuncture |
| Sham acupuncture | Sham comparator | Other: ElectroacupunctureSham Acupuncture needles will be placed at standardized acupuncture points. Sham electrical current will then be applied using 2 channels / 4 points as in the electroacupuncture group. The electrical current will not be turned on. |
| Waitlist | No intervention | –The wait list group will be required to complete questionnaires at 4 separate time points over the 12 week study period. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
Key exclusion criteria (4 listed)
- Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
- Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.
- Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.
- Other: allergy to needle components, needle phobia, pregnancy
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 |
|---|---|---|
| ElectroacupunctureAlso: Electrical acupunctureAcupuncture needles are inserted into the body at standardized acupuncture points. An electrical current is then applied to 4 needles through 2 channels of electrical current. The sham group receives the same protocol with sham needles and sham electrical current. | Other | Electroacupuncture, Sham acupuncture |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Disease specific outcome measure. Measuring change in disease specific function over 4 time points (as noted below). The WOMAC provides a multidimensional assessment inclusive of activities of daily life (ADL's), functional mobility, gait, general health, and quality of life organized into 3 subscales (pain, stiffness, physical function) consisting of 24 items scored on a 5-point scale from 0-4. Higher scores represent higher pain values or worse function for a total possible score of 96.
3 secondary outcomes
The Short Form-Survey 36 (SF-36)
Time frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
The Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No. Undetermined at this time
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Knee Osteoarthritis, run by University of Manitoba at 1 site in Canada.
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 4 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: withdrawn, as of the sponsor's last update on 24 Apr 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 Canada. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2024.