Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis

NCT02320500 | Completed Phase 4 DMC

• 2 other identifiers: ANAE-217-12NOL 158909
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the investigators expect those who receive myofascial-specific therapy to experience reduced pain (compared to the standard therapy group) and increased flexibility compared to baseline levels. This simple conservative therapy could postpone (or in some cases, eliminate) the need for a knee replacement since pain is the major indication for surgery. If successful, this treatment could improve the quality of life and increase productivity for thousands suffering from knee osteoarthritis and preserve valuable health care resources.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain scores on visual analogue scale (VAS)

  8 weeks

Secondary Outcomes (8)

• Brief pain inventory (BPI)

  biweekly for 8 weeks, 3 months, 6 months

• Oxford knee score

  biweekly for 8 weeks, 3 months, 6 months

• McGill short pain questionnaire

  biweekly for 8 weeks, 3 months, 6 months

• timed up and go (TUG)

  Baseline, 3 months

• 6 minute walk test

  Baseline, 3 months

Study Arms (2)

standard physiotherapy

ACTIVE COMPARATOR

Standard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA)

Behavioral: Standard Physiotherapy

Myofascial-specific therapy

EXPERIMENTAL

Patient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks)

Other: Myofascial-specific therapy

Interventions

Standard Physiotherapy BEHAVIORAL

standard of care physiotherapy once every 2 weeks for 8 weeks

standard physiotherapy

Myofascial-specific therapy OTHER

Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)

Myofascial-specific therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of bi or unilateral knee OA
• knee pain attributed to knee OA
• referral to orthopedics as a potential candidate for knee total knee arthroplasty
• ability to comprehend/sign consent, independent mobility without assistive devices

You may not qualify if:

• allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
• infections of clinical abnormalities other than knee OA that could cause the knee pain
• other diagnosed chronic pain syndrome for which they are taking regular pain medications
• pregnancy or breast-feeding

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Henry, MD, FRCPC

  Queens University/Kingston General Hospital

  PRINCIPAL INVESTIGATOR

• Gavin Wood, MD, FRCSC

  Queens University/Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 19, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

CA (1)