Marcussen, Britt - Knee Pain in the Trenches- Injections ... · • change of 2.8% in pain and function per % body-weight • 10% weight reduction results in 28% decline in knee OA

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KNEE PAIN IN THE TRENCHES: INJECTIONS, INSURANCE FIGHTS AND CONSULTS

Britt Marcussen, MDDirector of the Primary Care Sports Medicine Fellowship

University of Iowa

Vanderbilt Sports Medicine

Objectives

• To present the best available evidence for the treatment of the two common knee problems in primary care: Knee Osteoarthritis and Meniscus Tears in the adult population. We will discuss old/new and evolving evaluation and treatment strategies.


• 40 year old triathlete presents with 6 months of worsening global knee pain. Pain is medial, it clicks and swells at times. X-rays show grade 3 OA.

• Why does a 40 yo have OA, could something else be the pain generator?

• Will your Hx and PE help you?

• Do you need an MRI?

• How should you logically go about treating this…what are your next steps if what you try 1st/2nd tx’s don’t help?

CASE

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KNEE OSTEOARTHRITISDEFINITION

• Progressive joint disorder

• Deterioration of articular cartilage

• Reactive new bone formation

• Synovial thickening

• Most common cause of walking-related disability among older adults in the USA

• Prevalence and incidence increasing rapidly especially in the overweight and obese population!


DEFINITION AND GRADING OF OA

• Radiographic OA and symptomatic OA definitions are both used widely and are clinically pertinent but don’t always correlate with each other!

• Most commonly used radiologic grading system for knee OA is the Kellgren-Lawrence (K-L) grade

• Determines severity of OA on basis of presence and degree of osteophytes and joint space narrowing

• Symptomatic OA: Includes pain, stiffness and loss of ROM

Vanderbilt Sports MedicineFOOTER

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Figure 1. Risk factors for osteoarthritis and related disability.

Pradeep Suri, David C. Morgenroth, David J. Hunter

Epidemiology of Osteoarthritis and Associated Comorbidities

PM&R, Volume 4, Issue 5, Supplement, 2012, S10–S19

http://dx.doi.org/10.1016/j.pmrj.2012.01.007

RISK FACTORS


TREATMENT OPTIONSI. Behavior modifications

A. Patient Education

B. Physical Therapy and

Exercise

C. Weight Loss

D. Braces and Orthoses

E. Thermotherapy and

Cryotherapy

II. Intra-articular treatment

A. Corticosteroids

B. Viscosupplamentation

C. PRP/Stem Cells

III. Drug therapy

A. NSAIDs

B. Tylenol


PATIENT EDUCATIONDESCRIPTION

• Focuses on understanding disease and treatment options

• Assists in developing individualized exercise and cognitive pain management programs

• Attempts to improve self-efficacy

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PATIENT EDUCATIONEMOTIONAL IMPACT OF KNEE OA


PATIENT EDUCATIONEVIDENCE – LEVEL I

• Meta-analysis conducted on 16 studies reporting exercise and/or patient education for patients with knee OA

• Effects on physical and psychological well-being were assessed


PATIENT EDUCATIONEVIDENCE – LEVEL I

• 13 intervention arms consisted of a variety of self-management programs (targeting patients alone or patients with their spouses)

• Education regarding the nature of OA, treatment methods, and joint protection

• Cognitive and behavioral coping methods

• Instruction in activity-rest cycling

• Exercises requiring little equipment

• Diet and lower caloric intake

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PATIENT EDUCATIONEVIDENCE – LEVEL I• Physical outcomes (n = 387)

• mean effect very small (0.09, 95% CI -0.01, 0.19)

• p = 0.64• Psychological outcomes (n = 264)

• mean effect small (0.20, 95% CI 0.08, 0.33)

• p < 0.03 compared to control• Direct measures of impairment (n = 44)

• mean effect almost null (0.04, 95% CI -0.25, 0.34)

• p = 0.54


PATIENT EDUCATIONCONCLUSION

• Patient education improves psychological outcomes, small effect size

• Patient education has no (or very small) effect upon physical outcomes


I. Behavior modifications


B. Physical Therapy and Exercise

C. Weight Loss


E. Thermotherapy and Cryotherapy

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PHYSICAL THERAPY AND EXERCISE PRESCRIPTION • Major components

• Strengthening

• Stretching

• Aerobic conditioning

• Additional benefits

• Produces weight loss?

• Improves psychological well-being

• Maintains cartilage integrity

• Improves bone density


PHYSICAL THERAPY AND EXERCISEEVIDENCE – LEVEL I

• Systematic review of effects of PT on knee OA• randomized controlled trials

• WOMAC as outcome measure

• > 80% patient follow-up at time of final data collection


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PHYSICAL THERAPY AND PAIN– LEVEL I


PHYSICAL THERAPY AND FUNCTION– LEVEL I

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PHYSICAL THERAPY CONCLUSIONS (LEVEL 1)• Physical therapy likely improves pain and function (3/6 studies with a

small effect size)

• Physical therapy has minimal adverse effects





C. Weight Loss




WEIGHT LOSS

• Weight reduction reduces the stress on weight bearing knee joints

• Each weight-loss unit was associated with a 4-unit reduction in knee-joint forces

• Obesity (body mass index > 30) is an increasing issue in United States

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OBESITY TRENDS1995

(*BMI 30, or about 30 lbs overweight for 5’4” person)

2005

1990

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%


OBESITY TRENDS - 2017

FOOTER


WEIGHT LOSSEVIDENCE – LEVEL I

• Assessed the effect of rapid diet-induced weight loss upon the function of obese, knee arthritis patients

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WEIGHT LOSSEVIDENCE – LEVEL I

Control diet group

• Ordinary foods

• ~ 5 MJ/day

• Initial presentation by dietician

• Booklet of “good advice”on weight reduction

Low-energy diet group

• Nutrition powder taken as six daily meals

• ~ 3.4 MJ/day

• Weekly nutrition instruction and behavioral therapy by dietician


•Changes in body weight and body composition were examined

•Symptoms of OA were monitored by the WOMAC OA index, visual analogue scale version


• 1383 patients with symptomatic knee OA (71% female), mean age 64, mean BMI was 34.4 enrolled in a weight loss program.

• WOMAC and KOOS scores assessed at baseline/6wks/18wks

• There was a dose response relationship between weight loss and symptomatic improvement (>7.7% wt loss to produce a meaningful clinically important improvement in function)

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WEIGHT LOSS CONCLUSIONS• Weight loss:

• change of 2.8% in pain and function per % body-weight

• 10% weight reduction results in 28% decline in knee OA related pain/function

• There is a dose response effect

• Body fat:

• change of 9.4% pain/function per % body-fat

• NNT calculated on the basis of > 50% reduction in total pain/function scales was 4 !





C. Weight Loss




BRACES AND ORTHOSESDESCRIPTION• Medical devices added to body

• support

• align

• correct deformity

• assist weak muscles

• improve proprioception

• Decrease load transmitted through arthritic compartment

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BRACES AND ORTHOSESDESCRIPTION

Unloader brace Laterally elevatedwedged insole


BRACES AND ORTHOSESEVIDENCE – LEVEL I

•Prospective, randomized clinical trial

•Purpose of study was to compare three interventions:

•custom-made valgus-producing functional knee (unloader) brace

•neoprene sleeve

•medical treatment only


BRACES AND ORTHOSESEVIDENCE – LEVEL I

•119 patients randomized (computer-generated block method)

•Outcome measures

•Primary outcome – WOMAC (6-month change)

•Functional assessment

•6-minute walking test

•30-second stair-climbing test

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BRACING – LEVEL 1 EVIDENCE

FOOTER

• 91 patients prospectively enrolled w/ medial compartmental knee OA

• Randomized to 10-mm laterally wedged insole or a valgus brace

• Primary outcome measure was pain severity per VAS

• Secondary outcome measure knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs

• Results:

• No difference in pain or WOMAC score between the two groups

• Neither device achieved correction of knee varus malalignment in frontal plane


BRACES AND ORTHOSESCONCLUSIONS

• There are mixed results in Level 1 studies of unloaderbraces. –keep in mind who is a good candidate for these-

• Laterally wedged insole have limited support in the literature but are cheep and harmless! I do try them (level 5)

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I. Health and behavior modifications



C. Weight Loss




Heat Therapy

• Relaxes muscles

• Increases circulation

Cold therapy

• Temporarily numbs area

• Reduces inflammation


THERMOTHERAPY AND CRYOTHERAPYEVIDENCE – LEVEL II

• Two independent reviewers searched for RCTs

• knee osteoarthritis

• interventions using heat or cold therapy

• 3 RCTs were included in this review

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THERMOTHERAPY AND CRYOTHERAPYCONCLUSIONS

• No adverse affects of the treatments were reported in included trials

• Carefully applied cryotherapy may be used as an adjunct to pain treatment

• Further studies reflecting the clinical practice of using thermotherapy as an adjunct to physical therapy are needed


TREATMENT OPTIONS

III. Drug therapy

A. NSAIDs

B. Tylenol


• Objective: To investigate the efficacy of BID diclofenac topical solution vs vehicle control solution

• Design: a phase II, 4 week, randomized, double-blind, parallel-group, two-arm, vehicle controlled study compared pain relief in patients 40-85 years with radiographically confirmed primary OA

• Primary outcome – change from baseline WOMAC pain subscale

• Treatment-emergent adverse events also assessed

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TOPICAL NSAIDS-LEVEL 1

FOOTER

• Results: 259 patients

• Significant reduction in WOMAC pain scores observed for diclofenac-treated (-4.4) vs vehicle-treated patients (-3.4) at the final visit (p=0.04)

• Adverse events noted more in vehicle-treatment group than diclofenac group

• Conclusion: administration of diclofenac sodium 2% topical solution BID resulted in significantly greater improvement in pain reduction in patients with knee OA

• Clinical Implications: compared to oral NSAIDs, topical NSAIDs somewhat reduce amount of systemic exposure, so may be beneficial for pts with comorbidities or difficulty swallowing oral medications


• Lancet Meta-Analysis form 2016

• 74 RCT

• 58,556 patients

• NSAIDs clearly work to produce a clinically meaningful differnce

• Diclofenac 150mg per days was the most effective at reducing both pain and function.

NSAIDS

FOOTER

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CURRENT RECS FORTHE USE OF NSAIDS

FOOTER

• The FDA expert advisory committee recommends that:


• 7 trials identified looking at Tylenol vs. placebo

• All done on patients with OA

• There was no evidence that Tylenol produced any clinically meaningful differences in pain or function.

WHAT ABOUT GOOD OLD TYLENOL?

FOOTER

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• There is no high quality evidence for the use of glucosamine, narcotics or cannabanoids medication in the treatment of chronic osteoarthritic pain!

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A. Corticosteroids

B. Viscosupplementation


INTRA-ARTICULAR CORTICOSTEROIDSDESCRIPTION

• Long-lasting crystalline suspensions of corticosteroid injections (CSI) have been used since the 1950s

• Decreases inflammation/pain

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INTRA-ARTICULAR CORTICOSTEROIDS

FOOTER

• Cochrane review from 10/22/15

• Objective: to determine benefits and harms of intra-articular corticosteroids compared to sham or no intervention

• Evaluated 27 randomized controlled trials (13 new studies) – total of 1767 participants

• Duration: 2 weeks – one year

• Findings: corticosteroids more effective in function improvement than control interventions

• Difference of functional scores of -0.7 units on WOMAC disability scale

• Pain improvement: 44% of people in steroid group compared to 31% of placebo groups

• Fewer side effects seen in the corticosteroid group than the placebo


• Analysis of multiple time points suggested effects decrease over time

• No evidence that an effect remains 6 months after a corticosteroid injection

• A dose equivalent to 50 mg of prednisone may be needed to show longer benefit

• No evidence of an effect of corticosteroids on QOL compared to control

• No evidence of an effect of corticosteroids on joint space narrowing

• Graded quality of evidence as low for all findings – highly discordant results across studies


DO REPEAT CS INJECTIONS DO MORE HARM IN THE LONG RUN?

FOOTER

• Several Recent Studies have demonstrated faster joint deterioration with repeat CS injections.

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INTRA-ARTICULAR CORTICOSTEROIDSCONCLUSIONS

• Corticosteroids decrease pain by roughly 1/3

• Corticosteroids provide that benefit for 1 week-6 months

• Triamcinolone hexacetonide appears to be more efficacious than alternatives

• Repeat CS injection may be condrotoxic

• Because of the difficulty with how the studies were done: Level 2

• Some increasing evidence of chondortoxicity with frequently done injections



A. Corticosteroids

B. Viscosupplementation


VISCOSUPPLEMENTATIONDESCRIPTION

• Hyaluronic acid (HA) is critical constituent component of normal synovial fluid

• In OA, concentration and molecular weight of intra-articular HA are decreased

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VISCOSUPPLEMENTATIONBACKGROUND

• Original rationale for HA injection was to restore viscoelasticity of synovial fluid

• Possible additional benefits:• Normalize synthesis of endogenous HA

• Inhibit degradation of endogenous HA

• Relieve joint pain


TWO MOST RECENT OPPOSING VIEWS

FOOTER


• “We RECOMMEND viscosupplementation injections for K-L grade II-III knee osteoarthritis in those patients above the age of 60 years based on HIGH quality evidence demonstrating...

• “We SUGGEST viscosupplementation injections for knee osteoarthritis for those under the age of 60 years based on MODERATE quality evidence.

• Furthermore, high quality studies are needed to address the residual uncertainties regarding the clinical benefit achieved from HA injection, especially in the active 40- to 60-year age group.

AAOS AMSSM

FOOTER

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• The purpose of this study was to compare the efficacy of hyaluronic acid (hylan G-F 20) with triamcinolone acetonide as a single intra-articular injection for knee osteoarthritis.

• First double-blind, randomized controlled trial comparing a single-shot hyaluronic acid injection with a single-shot corticosteroid

• Triamcinolone acetonide relieved pain better and faster in the first week

• Both groups had improvement in pain, knee function, and range of motion during the 6-month follow-up (p < 0.0001).



FINDINGS

FOOTER

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SUMMARY• Based on Level 1 and Level 2 data Viscosupplementation works but has a

higher complication rate compared to CS injection.

• Level 5 evidence: Viscosupplementation can be worth a try in individual patients with mild to moderate knee OA who fail CS injection. It is likely less helpful in patients with advanced OA. It is expensive and it is getting more and more difficult to get it covered.


• Level of evidence 1 or 2

• Prospective single blind placebo controlled trial of 25 patients

• BMAC in one knee and saline in the other

• Outcomes were pain and function as measured by OARSI and VAS at 1w, 3 mo and 6 mo

• No difference between knees-both were significantly better at all endpoints (p>0.01)

STEM CELLS

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• 2880 studies identified of which 252 studies were included for analysis (100 articles for in vitro studies, 111 studies for animal studies; and 31 studies for human studies). There was a large variance in cell source in pre-clinical studies both of terms of animal used, location of harvest (fat, marrow, blood or synovium) and allogeneicity. The use of scaffolds, growth factors, number of cell passages and number of cells used was hugely heterogeneous.

• Conclusions: This review offers a comprehensive assessment of the evidence behind the translation of basic science to the clinical practice of cartilage repair. It has revealed a lack of connectivity between the in vitro, pre-clinical and human data and a patchwork quilt of synergistic evidence. Drivers for progress in this space are largely driven by patient demand, surgeon inquisition and a regulatory framework that is learning at the same pace as new developments take place.

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• Level 1 evidence

• 114 patients were screened and 30 included

• Randomized to PRP vs. saline for a series of 3 weekly injections

• Followed for 12 months

• WOMAC at 12 months scored were improved by 78% compared to 7% for the placebo group

• 19 women 11 men mean age of 50

PRP

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• Level 1

• Randomized prospective doule blind intervention trial

• 192 patients

• 3 weekly injections

• Follow up at 2, 6 and 12 months

• Multiple scales measured endpoints pain and function

• Both groups improved at all endpoints and in all subjective measure of pain and function. No significant differences between groups were noted

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• Level 1

• Double blind placebo controlled

• 78 patients randomized/74 analyzed

• WOMAC scores at 6 w, 3 months and 6 months

• 1 vs. 2 injections of PRP compared to saline.

• All WOMAC scores improved significantly at all endpoints in the PRP groups (no difference between one and three injections) compared to placebo.

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• 2019 Study:Arthroscopy

• 53 patients

• Prospective Double Blind Trial

• PRP vs HA vs Saline

• WOMAC and IKDC scores at 1/2/6/12 mo

• All three groups were improved at 1 mo

• Only PRP was still improved at 12 mo

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• AJSM 2019

• Double Blind RCT over 5 years

• 192 pateints KG 1-3 OA/167 completed the study

• 3 weekly PRP or HA injections

• IKDC scores at 2/6/12/24/64.3 mo

• Both treatments worked for both function and pain up to 64 mo but was statistically significant only in the PRP group

• Reintervention rates were lower at 24 mo in the PRP group (22 vs 37%)

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SUMMARY• Level I evidence

• Patient education (Psychologic outcomes only)

• Physical therapy (WOMAC pain and function)

• Weight loss (WOMAC pain and function)

• Unloader brace (WOMAC pain; varus knees)

• Cryotherapy (pain)

• Corticosteroid injection (VAS pain x 1 week-6mo)

• Viscosupplementation (as good a CS, cannot recommend for or against)

• NSAID both Topical and Oral (WOMAC pain)

• PRP (WOMAC, some promising preliminary data)

• Stem Cell (cannot recommend at this time)

• Tylenol (cannot recommend at this time)

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CASE

FOOTER

• Nothing you have tried has worked….your partner sees the patient and orderes an MRI


WHAT THE HECK DOES THE MENISCUS DO?

FOOTER

• Meniscal functions

• dissipate stresses associated with axial loads upon knee

• facilitate load transmission

• reduce stress seen by articular cartilage

• aid in joint lubrication and nutrition


• Functions made possible by complex infrastructure

• circumferentially oriented collagen fibers

• stabilized by periodic radial fibers

• wedge-shaped to absorb shock

• improve joint congruency to distribute force between femur and tibia

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• Joint forces

• in extension = meniscus sees nearly 50% of load

• in 90o flexion = can see up to 85% of force across the joint

• Total Meniscectomy (Barantz et al.,AJSM 1986)

• Reduces joint surface contact by 75%

• Peak stress increases by 235%

• Shock absorption decreases by 16%


DIAGNOSTIC METHOD: HISTORY

FOOTER

• Thorough history is important in all patients presenting with a knee complaint

• Note patient's age and activity level

• Specific questions

• mechanism of injury

• presence of swelling

• location of pain

• stability of the knee

• presence of mechanical symptoms


DIAGNOSTIC METHOD-HISTORY

FOOTER

• Level II & III

• Few studies have evaluated the accuracy of clinical history alone in diagnosing patients with a possible meniscus tear

• History can increase suspicion for a meniscal tear

• History alone is less accurate than physical exam

(Boeree & Ackroyd Injury 1991, Jackson et al. Ann Intern Med 2003)

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DIAGNOSTIC METHODS-HISTORY

FOOTER

• Level I

• Although not the focus of the study, Corea et al. reported that more than 50% of patients with meniscal tears had mechanical symptoms and recurrent effusions

• Main goal of study was to assess McMurray’s test

• Abdon et al. also reported strong association with presence of mechanical symptoms in meniscal tears

(Corea et al. Knee Surg Sports Traumatol Arthrosc 1994, Abdon et al. Int Orthop 1990)


DIAGNOSTIC METHODS-EXAM

FOOTER

• Two systematic reviews (Level II) focused on physical exam and diagnosis

• joint line tenderness consistently highly sensitive (67-92%) in detecting tears

• However, presence of joint line tenderness has been shown (Level II) to be neither sensitive nor specific when the patient has underlying arthritis or an acute ligamentous injury to the knee

(Solomon et al. JAMA 2001, Ryzewicz et al. CORR 2007, Shelbourne et al. AJSM 1995)


DIAGNOSTIC METHODS-EXAM

FOOTER

• Many specific physical exam tests have been described to assess for meniscal tears

• Each test attempts to manipulate the meniscus between the joint surfaces to recreate pain or mechanical symptoms

• McMurray’s test

• Apley’s test

• Thessaly’s test

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MCMURRY TEST

FOOTER

• Examiner places one hand on patient's knee flexed to 90 degrees

• Places other hand on patient's foot

• Foot is then internally/externally rotated while applying a valgus/varus load to the knee

• Recreation of pain or popping at the joint line is considered a positive test


THESSALY

FOOTER

• Instruct patient to stand on affected leg at either 5 or 20 degrees of knee flexion

• Patient uses one or two hands for balance

• Followed by internally and externally rotating the torso at the knee

• Positive test causes pain and/or clicking at the related site on the joint line

• With the exception of the Thessaly test at 20 degrees of flexion (both sensitive 89-92% and specific 96-97%) these tests were associated with lower sensitivities as compared with joint line tenderness (Level II SRs)

(Solomon et al. JAMA 2001, Ryzewicz et al. CORR 2007)


DIAGNOSTIC METHOD-RADIOGRAPHS

FOOTER

• Englund et al. (Level II) evaluated the presence of meniscal tears on knee MRIs in middle aged and elderly persons aged 50-90

• Found that among patients with Kellgren-Lawrence grade 2 or higher findings on radiographs, the prevalence of a meniscal tear

• 63% among patients with knee pain and stiffness on most days

• 60% among patients who were completely asymptomatic

• In patients without radiographic evidence of osteoarthritis, the corresponding prevalence were 32% and 23%, respectively

(Englund et al. NEJM 2008)

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DIAGNOSTIC METHODS-MRI

FOOTER

• MRI is diagnostic imaging modality of choice for meniscal tears

• Two recent systematic reviews found MRI both highly sensitive and specific for detecting meniscal tears (Level II)

(Crawford et al. Br Med Bull 2007, Ryzewicz et al. CORR 2007)


SURGERY VS NON-OPERATIVE CARE

FOOTER


NEJM-2013

FOOTER

• Multicenter, randomized, double blind, sham-controlled trial (Level 1)

• 146 patients age 35-65, mean age 52, BMI approx 27 in both groups

• Symptoms c/w degenerative meniscus tears and no knee osteoarthritis (patient had radiographs including MRI to confirm a tear)

• Random assignment to sham vs. meniscectomy

• Primary outcomes were changes in scores in the Lyshom and Western Onterio Menisal Evaluation Tool and knee pain after exercise at 12 months.

• There were no significant differences in any of the endpoints including need for subsequent surgery or adverse events.

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PT VS. MENISCECTOMY THE BMJ | BMJ 2016;354:I3740 | DOI: 10.1136/BMJ.I3740

FOOTER


BMJ-2016

FOOTER

• Blinded Randomized controlled trial (level 1)

• 140 patients average age 49.5 with degenerative medial meniscal tears verified by MRI. 95% had no definitive radiographic OA

• 12 weeks of PT vs. meniscectomy alone

• Outcomes were KOOS scores (pain/symptoms/function/quality of life) at 3/12/24 months

• No change at 2 years. 19% in the exercise group crossed over to the surgery group without benefit.


MECHANICAL SYMPTOMS?

FOOTER

• Advocates for knee arthroscopy will and do argue that there is a subset of patients with “mechanical” symptoms (catching and locking) would benefit from surgery (Lyman et al., Arthroscopy 2012;28(4). 492-501 e1)

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SIHVONEN ET AL, 2016

FOOTER

• Prospective Cohort

• 900 patients with symptomatic degenerative knee disease and meniscus tear

• Outcome: WOMET scores at one year between those reporting mechanical symptoms and those not reporting mechanical symptoms

• The proportion of patients satisfied with their knee 12 months after arthroscopy was significantly lower among those with preoperative mechanical symptoms than among those without (61% vs 75%, multivariable adjusted risk ratio [RR] 0.84; 95% confidence interval [CI] 0.76, 0.92).

• Similarly, the proportion reporting improvement was lower (RR 0.91; 95% CI 0.85, 0.97).

• No statistically significant difference was found in change in WOMET or NRS between the two groups.

• Of those with preoperative mechanical symptoms, 47% reported persistent symptoms at 12 months postoperatively.


SUMMARY

FOOTER

• There is no level 1 evidence that arthroscopic meniscus surgery is beneficial for degenerative meniscus tears in patients with or without mechanical symptoms.

• There is good level 1 evidence that arthroscopy for degenerative meniscal pathology is no better than conservative care.

• Mechanical symptoms can be other things-loose body…so an MRI at some point is not unreasonalbe to rule these things out especially in patients with lower grade OA.

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THANK YOU

Documents

Marcussen, Britt - Knee Pain in the Trenches- Injections ... · • change of 2.8% in pain and function per % body-weight • 10% weight reduction results in 28% decline in knee OA