Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement

Aalborg University

Status: Completed

Conditions: Arthroplasty, Replacement, Knee; Chronic Pain

Treatments: Other: Pain neuroscience education; Other: Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education

Study type: Interventional

Funder types: Other

Identifiers

NCT03886259

N-20180046

Details and patient eligibility

About

The purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (NEMEX-TJR) combined with pain neuroscience education (PNE) provides greater pain relief, improvement in physical function and quality of life than PNE alone in a population of patients with chronic pain after primary total knee arthroplasty.

Hypothesis: Rehabilitation involving neuromuscular training and PNE will provide greater pain relief, improved function and improved quality of life compared to PNE alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

Full description

Osteoarthritis is considered the most frequent cause of disability and pain in the elderly population, and the knee joint is one of the joints most commonly affected.

End-stage osteoarthritis is often treated with knee replacement, and total knee arthroplasty is considered an effective treatment for pain relief and improved function. However, several studies have reported less favorable outcomes after total knee arthroplasty, and systematic reviews found chronic pain after total knee arthroplasty at 12 months post-operative in 13-17% of the patients and chronic pain rates at 2-7 years post-operative varying between 8-27%. No randomized controlled trials evaluating exercise and pain education treatments to patients with chronic pain after total knee arthroplasty exists, and this highlights the need for evidence-based knowledge of which treatment should be considered for this population.

Enrollment: 71 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) between 19-40
• Subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively
• For the index knee, duration of knee pain > 6 months
• For the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale

Exclusion criteria

• Specific reasons for chronic pain, such as loosening of implant, which requires revision surgery
• Secondary causes of arthritis to the knee, e.g. rheumatoid arthritis
• Surgery (including arthroscopy) of the index knee within 3 months prior to visit
• Injury to the index knee within 12 months prior to visit
• Recent history of acute pain affecting the lower limb and/or trunk
• Participation in other pain trials two weeks prior to this study
• Pregnancy
• Drug and alcohol abuse
• Previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis
• Lack of ability to adhere to protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Exercise and pain neuroscience education

Experimental group

Description:

Subjects with chronic pain after total knee replacement will receive 24 sessions of neuromuscular exercise therapy, supervised by a physiotherapist, and two sessions of pain neuroscience education, conducted by a physiotherapist

Treatment:

Other: Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education

Pain neuroscience education

Active Comparator group

Description:

Subjects with chronic pain after total knee replacement will receive two sessions of pain neuroscience education, conducted by a physiotherapist

Treatment:

Other: Pain neuroscience education