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

NCT ID: NCT02320500

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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.

Detailed Description

Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.

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.

The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.

The Secondary outcomes will include:

(Comparisons between and/or within groups where appropriate):

• Pain score biweekly up to 8 weeks, at 3 months and 6 months
• Decision to proceed with surgery (yes/no)-to assess the alteration in the need for TKA
• Decision to continue treatment-(yes/no) is treatment beneficial?
• Function -Biodex, 6 min.walk test, Timed up and go- Measured at baseline and 3 months following last therapy session for standard vs. myofascial -is myofascial therapy better for function?
• Brief Pain Interference (BPI) short form- Baseline, 2 weeks and 8 weeks- to assess pain interference
• Oxford knee scores-Baseline, 2 and 8 weeks- reported functional disability (compare groups and to objective measures)
• McGill SF pain questionnaire at Baseline, 2 weeks and 8 weeks-to assess pain quality
• SF-12 at Baseline, 2 weeks and 8 weeks-to assess quality of life
• Analgesics consumed at Baseline, 2 weeks, 8 weeks, 6 months-to assess pain levels
• Compare the X-ray osteoarthritis (OA) grade with initial assessment of MTPs-Does presence of myofascial trigger points (MTPs) explain discordance between OA grade and pain?
• Pain scores on a 10 cm visual analogue scale at Baseline, 2 weeks, 6 months- assess change in pain intensity
• Surgery by 6 month follow-up? Yes/No, If so, when? - postponed or eliminated need for TKA?

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard physiotherapy

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)

Group Type: ACTIVE_COMPARATOR

Standard Physiotherapy

Intervention Type: BEHAVIORAL

standard of care physiotherapy once every 2 weeks for 8 weeks

Myofascial-specific therapy

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)

Group Type: EXPERIMENTAL

Myofascial-specific therapy

Intervention Type: OTHER

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

Interventions

Standard Physiotherapy

standard of care physiotherapy once every 2 weeks for 8 weeks

Intervention Type: BEHAVIORAL

Myofascial-specific therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gavin Wood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Henry, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queens University/Kingston General Hospital

Gavin Wood, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queens University/Kingston General Hospital

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

NOL 158909

Identifier Type: OTHER

Identifier Source: secondary_id

ANAE-217-12

Identifier Type: -

Identifier Source: org_study_id