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

NCT05374330 | Withdrawn

• 1 other identifier: H2022:100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• The Short Form-Survey 36 (SF-36)

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

• The Short Form McGill Pain Questionnaire (SF-MPQ)

  Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion

• Numeric Pain Rating Scale (NPRS)

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

Other Outcomes (1)

• Brief questionnaire

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

Study Arms (3)

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

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.

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.

Interventions

Electroacupuncture OTHER

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.

Also known as: Electrical acupuncture

Electroacupuncture; Sham acupuncture

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 16, 2022
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)