Clinical trial NCT05374330: Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Secondary outcomes:
measure: The Short Form-Survey 36 (SF-36)
timeFrame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
measure: The Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Other outcomes:
measure: Brief questionnaire
timeFrame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References: