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

Primary Purpose

Arthroplasty, Replacement, Knee, Chronic Pain

Status

Active

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education

Pain neuroscience education

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring Chronic Pain, Total Knee Arthroplasty, Pain Neuroscience Education, Neuromuscular exercise (NEMEX-TJR)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and pain neuroscience education

Pain neuroscience education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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'.

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.

Change in use of Pain Medication

Dosage of pain medication used within last week

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.

Change in 40-meter fast-paced walk test

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

Change in stair climb test

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

Change in 30-second chair stand test

Number of repetitions in 30-seconds

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.

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.

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.

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".

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".

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".

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.

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.

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

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

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.

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).

Full Information

NCT ID

NCT03886259

First Posted

March 20, 2019

Last Updated

January 19, 2023

Sponsor

Aalborg University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03886259

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroplasty, Replacement, Knee, Chronic Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcome assessors will be blinded towards group allocation.

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise and pain neuroscience education

Arm Type

Experimental

Arm Description

Arm Title

Pain neuroscience education

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Pain neuroscience education

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and at 3, 6 and 12 months

Secondary Outcome Measure Information:

Title

Change in all five subscales of the KOOS

Description

Time Frame

Baseline and at 3, 6 and 12 months

Title

Rating of Global Perceived Effect

Description

Time Frame

3, 6 and 12 months

Title

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

Description

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

Title

Change in use of Pain Medication

Description

Dosage of pain medication used within last week

Time Frame

Baseline and at 3, 6 and 12 months

Title

Number of adverse events related to interventions

Description

Time Frame

3 months

Title

Change in 40-meter fast-paced walk test

Description

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

Time Frame

Baseline and at 3, 6 and 12 months

Title

Change in stair climb test

Description

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

Title

Change in 30-second chair stand test

Description

Number of repetitions in 30-seconds

Time Frame

Baseline and at 3, 6 and 12 months

Title

Change in PainDETECT scores

Description

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

Title

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

Description

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

Title

Change in score from the Pain Catastrophizing Scale

Description

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

Title

Change in pinprick hyperalgesia at index knee and extrasegmental

Description

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

Title

Change in temporal summation at index knee and extrasegmental

Description

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

Title

Change in dynamic mechanical allodynia at the index knee and extrasegmental

Description

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

Title

Change in deep somatic hyperalgesia at the index knee and extrasegmental

Description

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

Title

Change in pressure pain thresholds at the index knee and extrasegmental

Description

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

Title

Change in descending pain control

Description

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

Title

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

Description

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

Time Frame

Baseline and at 3, 6 and 12 months

Title

Change in leg extension power

Description

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

Title

Change in isometric muscle strength of knee extensors and flexors

Description

Time Frame

Baseline and at 3, 6 and 12 months

Other Pre-specified Outcome Measures:

Title

Hospital Anxiety and Depression Scale

Description

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.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Madeleine, Dr.Scient

Organizational Affiliation

Aalborg University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Søren T Skou, PhD

Organizational Affiliation

University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ole Simonsen, Dr.Med

Organizational Affiliation

Aalborg University Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lars Arendt-Nielsen, Dr.Med

Organizational Affiliation

Aalborg University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jesper B Larsen, M.Sc.

Organizational Affiliation

Aalborg University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mogens B Laursen, PhD

Organizational Affiliation

Aalborg University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Occupational and Physiotherapy, Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Department of Occupational- and Physiotherapy, Aalborg University Hospital

City

Farsø

ZIP/Postal Code

9640

Country

Denmark

Facility Name

Department of Occupational- and Physiotherapy, Aalborg University Hospital

City

Thisted

ZIP/Postal Code

7700

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual subject data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, appendices)

IPD Sharing Time Frame

Beginning 3 months following publication. No end date.

IPD Sharing Access Criteria

Researchers that provide a methodologically sound plan

Citations:

PubMed Identifier

11156538

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.

Results Reference

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PubMed Identifier

15766999

Citation

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.

Results Reference

background

Citation

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

Results Reference

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PubMed Identifier

22398175

Citation

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.

Results Reference

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PubMed Identifier

16326719

Citation

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.

Results Reference

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PubMed Identifier

17596949

Citation

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.

Results Reference

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PubMed Identifier

22357571

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.

Results Reference

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PubMed Identifier

28681962

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.

Results Reference

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PubMed Identifier

25967998

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.

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PubMed Identifier

32197629

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.

Results Reference

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

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