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

April 22, 2024 updated by: Janine Didyk, University of Manitoba

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Barbara Shay

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electroacupuncture
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
Other: Electroacupuncture
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.
Other Names:
  • Electrical acupuncture
Sham Comparator: Sham acupuncture
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.
Other: Electroacupuncture
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.
Other Names:
  • Electrical acupuncture
No Intervention: Waitlist
The wait list group will be required to complete questionnaires at 4 separate time points over the 12 week study period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Short Form-Survey 36 (SF-36)
Time Frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
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.
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
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.
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
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.
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief questionnaire
Time Frame: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion

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
Baseline, 3 weeks, 6 weeks and 6 weeks after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2022:100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undetermined at this time

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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