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Completed

NCT Number: NCT03886259

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Occupational and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education

Other

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.

Pain neuroscience education

Other

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.

Primary outcomes

  1. Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up

    Time frame: Baseline and at 3, 6 and 12 months

    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.

Secondary outcomes

  1. Change in all five subscales of the KOOS

    Time frame: Baseline and at 3, 6 and 12 months

    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).

  2. Rating of Global Perceived Effect

    Time frame: 3, 6 and 12 months

    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'.

  3. Change in maximal pain intensity during rest (day and night), stair climbing, and walking on a Numeric Rating Scale (NRS)

    Time frame: Baseline and at 3, 6 and 12 months

    Pain intensities on a NRS, where "0" represents "no pain" and "10" represents "maximal pain" in various situations.

  4. Change in use of Pain Medication

    Time frame: Baseline and at 3, 6 and 12 months

    Dosage of pain medication used within last week

  5. Number of adverse events related to interventions

    Time frame: 3 months

    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.

  6. Change in 40-meter fast-paced walk test

    Time frame: Baseline and at 3, 6 and 12 months

    The amount of time in seconds it takes to complete the 40m

  7. Change in stair climb test

    Time frame: Baseline and at 3, 6 and 12 months

    The amount of time in seconds it takes to complete ascending and descending of 9 stairs

  8. Change in 30-second chair stand test

    Time frame: Baseline and at 3, 6 and 12 months

    Number of repetitions in 30-seconds

  9. Change in PainDETECT scores

    Time frame: Baseline and at 3, 6 and 12 months

    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.

  10. Change in score from the Fear-avoidance Beliefs Questionnaire - Physical Activity

    Time frame: Baseline and at 3, 6 and 12 months

    The scores range from "0" with "completely disagree" to "6" with "completely agree" and sums up to a total score between 0-24.

  11. Change in score from the Pain Catastrophizing Scale

    Time frame: Baseline and at 3, 6 and 12 months

    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.

  12. Change in pinprick hyperalgesia at index knee and extrasegmental

    Time frame: Baseline and at 3, 6 and 12 months

    The subject is to rate the pain intensity from the pinprick on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".

  13. Change in temporal summation at index knee and extrasegmental

    Time frame: Baseline and at 3, 6 and 12 months

    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".

  14. Change in dynamic mechanical allodynia at the index knee and extrasegmental

    Time frame: Baseline and at 3, 6 and 12 months

    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".

  15. Change in deep somatic hyperalgesia at the index knee and extrasegmental

    Time frame: Baseline and at 3, 6 and 12 months

    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.

  16. Change in pressure pain thresholds at the index knee and extrasegmental

    Time frame: Baseline and at 3, 6 and 12 months

    Pressure pain thresholds measured using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at the index knee and extrasegmental.

  17. Change in descending pain control

    Time frame: Baseline and at 3, 6 and 12 months

    Conditioned pain modulation effect will be measured comparing the test stimuli without conditioning stimuli to the test stimuli with conditioning stimuli

  18. Change in number of sites with usual pain shaded on a body chart

    Time frame: Baseline and at 3, 6 and 12 months

    Shaded markings on a body chart to indicate where usual pain is located

  19. Change in leg extension power

    Time frame: Baseline and at 3, 6 and 12 months

    Leg extension power in a single-leg simultaneous hip and knee extension will be measured bilaterally. Highest measurement in watt is the outcome.

  20. Change in isometric muscle strength of knee extensors and flexors

    Time frame: Baseline and at 3, 6 and 12 months

    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).

Other outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    The questionnaire consists of 14 items, which measures the patient level of anxiety and depression. The score in each item ranges from 0-3, giving scoring ranges from 0-21.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Lions Denmark
  • Northern Orthopaedic Division, Denmark
  • Svend Andersen Foundation
  • The Danish Rheumatism Association

Registry information

Official study title

Effect of Neuromuscular Exercise in Combination With Pain Neuroscience Education Compared to Pain Neuroscience Education Alone in Patients With Chronic Pain After Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2019
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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