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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
60min. of neuromuscular exercises (NEMEX-TJR) training two times a week for 3 months (12 weeks, 24 sessions). Physiotherapists will instruct and supervise the participants during the neuromuscular exercises. The aim of the neuromuscular exercise program is to restore normal movement, improve sensorimotor control, re-establishing normal motor program strategies and muscle activation. 60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function.
60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function.
Department of Occupational and Physiotherapy, Aalborg University Hospital
Aalborg, Denmark
Department of Occupational- and Physiotherapy, Aalborg University Hospital
Farsø, Denmark
Department of Occupational- and Physiotherapy, Aalborg University Hospital
Thisted, Denmark
Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up
The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be performed.
Time frame: Baseline and at 3, 6 and 12 months
Change in all five subscales of the KOOS
All five domains, covering pain, symptoms, difficulties in functions of daily living, sport and recreation and quality of life of the questionnaire will be used as secondary outcome with scores ranging from 0 (worst) to 100 (best).
Time frame: Baseline and at 3, 6 and 12 months
Rating of Global Perceived Effect
Global Perceived Effect will be assessed using the question: "How are your knee problems now compared with before you entered this study"? The question will be answered on a seven-point Likert scale ranging from 'Improved, an important improvement' to 'Worse, an important worsening'.
Time frame: 3, 6 and 12 months
Change in maximal pain intensity during rest (day and night), stair climbing, and walking on a Numeric Rating Scale (NRS)
Pain intensities on a NRS, where "0" represents "no pain" and "10" represents "maximal pain" in various situations.
Time frame: Baseline and at 3, 6 and 12 months
Change in use of Pain Medication
Dosage of pain medication used within last week
Time frame: Baseline and at 3, 6 and 12 months
Number of adverse events related to interventions
Serious and non-serious events that may occur during the intervention period will be identified in different ways: by self-reporting by the participants and by observation from the physiotherapists. Adverse events will be categorized as occurring in the index knee or other sites than the index knee.
Time frame: 3 months
Change in 40-meter fast-paced walk test
The amount of time in seconds it takes to complete the 40m
Time frame: Baseline and at 3, 6 and 12 months
Change in stair climb test
The amount of time in seconds it takes to complete ascending and descending of 9 stairs
Time frame: Baseline and at 3, 6 and 12 months
Change in 30-second chair stand test
Number of repetitions in 30-seconds
Time frame: Baseline and at 3, 6 and 12 months
Change in PainDETECT scores
The questionnaire is comprised of 3 major components: graduation of pain, pain course pattern and radiating pain. The maximum possible score is 38, and the minimum possible score is -1.
Time frame: Baseline and at 3, 6 and 12 months
Change in score from the Fear-avoidance Beliefs Questionnaire - Physical Activity
The scores range from "0" with "completely disagree" to "6" with "completely agree" and sums up to a total score between 0-24.
Time frame: Baseline and at 3, 6 and 12 months
Change in score from the Pain Catastrophizing Scale
Scores is rated on a 5-point scale with the 0 being "not at all" and 4 being "all the time" and the score can range from 0 to 52 points.
Time frame: Baseline and at 3, 6 and 12 months
Change in pinprick hyperalgesia at index knee and extrasegmental
The subject is to rate the pain intensity from the pinprick on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".
Time frame: Baseline and at 3, 6 and 12 months
Change in temporal summation at index knee and extrasegmental
The subject is to rate the pain intensity of the last test stimulus on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".
Time frame: Baseline and at 3, 6 and 12 months
Change in dynamic mechanical allodynia at the index knee and extrasegmental
The subject is to rate the pain intensity of a cotton swab on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".
Time frame: Baseline and at 3, 6 and 12 months
Change in deep somatic hyperalgesia at the index knee and extrasegmental
A "bedside algometer" will be applied on the skin over the vastus medialis muscle on the index side. The subject is to indicate immediately when the pressure becomes painful.
Time frame: Baseline and at 3, 6 and 12 months
Change in pressure pain thresholds at the index knee and extrasegmental
Pressure pain thresholds measured using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at the index knee and extrasegmental.
Time frame: Baseline and at 3, 6 and 12 months
Change in descending pain control
Conditioned pain modulation effect will be measured comparing the test stimuli without conditioning stimuli to the test stimuli with conditioning stimuli
Time frame: Baseline and at 3, 6 and 12 months
Change in number of sites with usual pain shaded on a body chart
Shaded markings on a body chart to indicate where usual pain is located
Time frame: Baseline and at 3, 6 and 12 months
Change in leg extension power
Leg extension power in a single-leg simultaneous hip and knee extension will be measured bilaterally. Highest measurement in watt is the outcome.
Time frame: Baseline and at 3, 6 and 12 months
Change in isometric muscle strength of knee extensors and flexors
Maximum isometric muscle strength (measured in Newtons) measured bilaterally in knee flexion and knee extension in a test using a handheld dynamometer (Lafayette manual muscle tester from Lafayette Instruments, USA).
Time frame: Baseline and at 3, 6 and 12 months
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