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Arthroplasty, Replacement, KneeNCT03886259

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

A study testing Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education and Pain neuroscience education in people with Arthroplasty, Replacement, Knee and Chronic Pain, run by Aalborg University at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Arthroplasty, Replacement, Knee, Chronic Pain
What is being tested?
Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education and Pain neuroscience education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
3 sitesDenmark
Study dates
1 Apr 2019to 8 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Department of Occupational and Physiotherapy, Aalborg University Hospital

    Aalborg, 9000

  • Department of Occupational- and Physiotherapy, Aalborg University Hospital

    Farsø, 9640

  • Department of Occupational- and Physiotherapy, Aalborg University Hospital

    Thisted, 7700

Other trials in Denmark

About this study

Official 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

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.

Read the detailed 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.

Being tested
Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education, Pain neuroscience education
Keywords
Chronic Pain, Total Knee Arthroplasty, Pain Neuroscience Education, Neuromuscular exercise (NEMEX-TJR)
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular exercises (NEMEX-TJR) and pain neuroscience educationOther

    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 educationOther

    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.

Study groups in NCT03886259
Study groupRoleWhat they receive
Exercise and pain neuroscience educationExperimentalSubjects 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
Receives: Other: Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education
Pain neuroscience educationActive comparatorSubjects with chronic pain after total knee replacement will receive two sessions of pain neuroscience education, conducted by a physiotherapist
Receives: Other: Pain neuroscience education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and at 3, 6 and 12 months

Secondary outcomes (20)

  1. 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).

    Measured: Baseline and at 3, 6 and 12 months

  2. 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'.

    Measured: 3, 6 and 12 months

  3. 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.

    Measured: Baseline and at 3, 6 and 12 months

  4. Change in use of Pain Medication

    Dosage of pain medication used within last week

    Measured: Baseline and at 3, 6 and 12 months

  5. 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.

    Measured: 3 months

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

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

    Measured: Baseline and at 3, 6 and 12 months

  7. Change in stair climb test

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

    Measured: Baseline and at 3, 6 and 12 months

  8. Change in 30-second chair stand test

    Number of repetitions in 30-seconds

    Measured: Baseline and at 3, 6 and 12 months

  9. 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.

    Measured: Baseline and at 3, 6 and 12 months

  10. 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.

    Measured: Baseline and at 3, 6 and 12 months

  11. 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.

    Measured: Baseline and at 3, 6 and 12 months

  12. 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".

    Measured: Baseline and at 3, 6 and 12 months

  13. 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".

    Measured: Baseline and at 3, 6 and 12 months

  14. 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".

    Measured: Baseline and at 3, 6 and 12 months

  15. 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.

    Measured: Baseline and at 3, 6 and 12 months

  16. 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.

    Measured: Baseline and at 3, 6 and 12 months

  17. 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

    Measured: Baseline and at 3, 6 and 12 months

  18. 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

    Measured: Baseline and at 3, 6 and 12 months

  19. 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.

    Measured: Baseline and at 3, 6 and 12 months

  20. 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).

    Measured: Baseline and at 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion21 Feb 2023
  4. Study completion8 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886259
Sponsor's protocol ID
N-20180046
Status last verified
May 2024
First submitted
20 Mar 2019
Last updated
2 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual subject data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, appendices)

Publications

  • Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.

    PubMed 11156538

  • Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.

    PubMed 15766999

  • Davidson D, de Steiger R, Graves S, Tomkins A et al. Australian orthopaedic association national joint replacement registry. annual report. Adelaide:AOA;2010. . 2010

  • Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

    PubMed 22398175

  • Bhave A, Mont M, Tennis S, Nickey M, Starr R, Etienne G. Functional problems and treatment solutions after total hip and knee joint arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:9-21. doi: 10.2106/JBJS.E.00628. No abstract available.

    PubMed 16326719

  • Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.

    PubMed 17596949

  • Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.

    PubMed 22357571

  • Wylde V, Dennis J, Beswick AD, Bruce J, Eccleston C, Howells N, Peters TJ, Gooberman-Hill R. Systematic review of management of chronic pain after surgery. Br J Surg. 2017 Sep;104(10):1293-1306. doi: 10.1002/bjs.10601. Epub 2017 Jul 6.

    PubMed 28681962

  • Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015 May 12;5(5):e007387. doi: 10.1136/bmjopen-2014-007387.

    PubMed 25967998

  • Larsen JB, Skou ST, Arendt-Nielsen L, Simonsen O, Madeleine P. Neuromuscular exercise and pain neuroscience education compared with pain neuroscience education alone in patients with chronic pain after primary total knee arthroplasty: study protocol for the NEPNEP randomized controlled trial. Trials. 2020 Feb 24;21(1):218. doi: 10.1186/s13063-020-4126-5.

    PubMed 32197629

  • Larsen JB, Skou ST, Laursen M, Bruun NH, Bandholm T, Arendt-Nielsen L, Madeleine P. The effects of supervised exercise and pain neuroscience education on muscle strength and power in patients with chronic pain after total knee arthroplasty: An exploratory analysis from the NEPNEP trial. Osteoarthr Cartil Open. 2026 Mar 25;8(2):100786. doi: 10.1016/j.ocarto.2026.100786. eCollection 2026 Jun.

    PubMed 42006953

  • Larsen JB, Skou ST, Laursen M, Bruun NH, Arendt-Nielsen L, Madeleine P. Exercise and Pain Neuroscience Education for Patients With Chronic Pain After Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2412179. doi: 10.1001/jamanetworkopen.2024.12179.

    PubMed 38787559

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education and Pain neuroscience education in people with Arthroplasty, Replacement, Knee and Chronic Pain, run by Aalborg University at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03886259, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

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