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Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ManitobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Electroacupuncture

Sham acupuncture

Waitlist

Arm Description

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

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.

The wait list group will be required to complete questionnaires at 4 separate time points over the 12 week study period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 29, 2022
Last Updated
May 8, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05374330
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

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

5. Study Description

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

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
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
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
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
The wait list group will be required to complete questionnaires at 4 separate time points over the 12 week study period.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
Electrical acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Secondary Outcome Measure Information:
Title
The Short Form-Survey 36 (SF-36)
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Title
The Short Form McGill Pain Questionnaire (SF-MPQ)
Description
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.
Time Frame
Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Other Pre-specified Outcome Measures:
Title
Brief questionnaire
Description
asks specific questions re: pain over the course of the study, use of medication. and blinding. Pain is asked in a descriptive format on a 7 point scale (much better/better/slightly better/no change/slightly worse/worse/worst). Medication use is asked on 5 point scale with the use of 0-same amount, 1- much less than usual, 2- somewhat less than usual, 3- somewhat more than usual, 4-significantly less than usual. Blinding questions is asked of the electroacupuncture and sham groups "I believe that I am receiving A= True acupuncture B= Sham acupuncture
Time Frame
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine J Didyk
Phone
2042940867
Email
umreidjj@myumanitoba.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Shay
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine J Didyk
Phone
2042940867

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Undetermined at this time

Learn more about this trial

Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist

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