Clinical trial NCT03886259: Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Chronic Pain
Keywords: Chronic Pain
Total Knee Arthroplasty
Pain Neuroscience Education
Neuromuscular exercise (NEMEX-TJR)
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Northern Orthopaedic Division, Denmark
name: The Danish Rheumatism Association
name: Svend Andersen Foundation
name: Lions Denmark
First posted: 2019-03-22
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up
timeFrame: Baseline and at 3, 6 and 12 months
Secondary outcomes:
measure: Change in all five subscales of the KOOS
timeFrame: Baseline and at 3, 6 and 12 months
measure: Rating of Global Perceived Effect
timeFrame: 3, 6 and 12 months
measure: Change in maximal pain intensity during rest (day and night), stair climbing, and walking on a Numeric Rating Scale (NRS)
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in use of Pain Medication
timeFrame: Baseline and at 3, 6 and 12 months
measure: Number of adverse events related to interventions
timeFrame: 3 months
measure: Change in 40-meter fast-paced walk test
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in stair climb test
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in 30-second chair stand test
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in PainDETECT scores
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in score from the Fear-avoidance Beliefs Questionnaire - Physical Activity
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in score from the Pain Catastrophizing Scale
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in pinprick hyperalgesia at index knee and extrasegmental
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in temporal summation at index knee and extrasegmental
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in dynamic mechanical allodynia at the index knee and extrasegmental
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in deep somatic hyperalgesia at the index knee and extrasegmental
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in pressure pain thresholds at the index knee and extrasegmental
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in descending pain control
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in number of sites with usual pain shaded on a body chart
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in leg extension power
timeFrame: Baseline and at 3, 6 and 12 months
measure: Change in isometric muscle strength of knee extensors and flexors
timeFrame: Baseline and at 3, 6 and 12 months
Other outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
Locations:
city: Aalborg
country: Denmark
facility: Department of Occupational and Physiotherapy, Aalborg University Hospital
city: Farsø
country: Denmark
facility: Department of Occupational- and Physiotherapy, Aalborg University Hospital
city: Thisted
country: Denmark
facility: Department of Occupational- and Physiotherapy, Aalborg University Hospital
Study officials:
affiliation: Aalborg University
name: Pascal Madeleine, Dr.Scient
role: STUDY_CHAIR
affiliation: University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
name: Søren T Skou, PhD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Ole Simonsen, Dr.Med
role: STUDY_CHAIR
affiliation: Aalborg University
name: Lars Arendt-Nielsen, Dr.Med
role: STUDY_CHAIR
affiliation: Aalborg University
name: Jesper B Larsen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Mogens B Laursen, PhD
role: STUDY_CHAIR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.