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

NCT03886259 | Completed DMC

• 1 other identifier: N-20180046
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthroplasty, Replacement, Knee; Chronic Pain

Keywords

Chronic Pain; Total Knee Arthroplasty; Pain Neuroscience Education; Neuromuscular exercise (NEMEX-TJR)

Outcome Measures

Primary Outcomes (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.

  Baseline and at 3, 6 and 12 months

Secondary Outcomes (20)

• Change in all five subscales of the KOOS

  Baseline and at 3, 6 and 12 months

• Rating of Global Perceived Effect

  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)

  Baseline and at 3, 6 and 12 months

• Change in use of Pain Medication

  Baseline and at 3, 6 and 12 months

• Number of adverse events related to interventions

  3 months

Other Outcomes (1)

• Hospital Anxiety and Depression Scale

  Baseline

Study Arms (2)

Exercise and pain neuroscience education

EXPERIMENTAL

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

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

Pain neuroscience education

ACTIVE COMPARATOR

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

Other: Pain neuroscience education

Interventions

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.

Exercise and pain neuroscience education

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.

Pain neuroscience education

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• Northern Orthopaedic Division, Denmark: collaborator
• The Danish Rheumatism Association: collaborator
• Svend Andersen Foundation: collaborator
• Lions Denmark: collaborator

Study Sites (3)

Department of Occupational and Physiotherapy, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Occupational- and Physiotherapy, Aalborg University Hospital

Farsø, 9640, Denmark

Location

Department of Occupational- and Physiotherapy, Aalborg University Hospital

Thisted, 7700, Denmark

Location

Related Publications (11)

• 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.

  PMID: 11156538 BACKGROUND

• 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.

  PMID: 15766999 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22398175 BACKGROUND

• 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.

  PMID: 16326719 BACKGROUND

• 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.

  PMID: 17596949 BACKGROUND

• 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.

  PMID: 22357571 BACKGROUND

• 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.

  PMID: 28681962 BACKGROUND

• 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.

  PMID: 25967998 BACKGROUND

• 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.

  PMID: 32197629 BACKGROUND

• 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.

  PMID: 38787559 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal Madeleine, Dr.Scient

  Aalborg University

  STUDY CHAIR

• Søren T Skou, PhD

  University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals

  STUDY CHAIR

• Ole Simonsen, Dr.Med

  Aalborg University Hospital

  STUDY CHAIR

• Lars Arendt-Nielsen, Dr.Med

  Aalborg University

  STUDY CHAIR

• Jesper B Larsen, M.Sc.

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Mogens B Laursen, PhD

  Aalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded towards group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: April 1, 2019
• Primary Completion: February 21, 2023
• Study Completion: April 8, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months following publication. No end date.
• Access Criteria: Researchers that provide a methodologically sound plan

Locations

DK (3)