Quality Measures for the Care of Lateral Epicondylalgia
Quality Measures for the Care of Lateral Epicondylalgia
Table 1 includes the recommendations identified in the first phase, and their evidence level and strength. None were based on CPG. From these recommendations, a total of 12 potential QMs were created and accepted for the pilot testing: 3 were related to assessment interventions, 1 to educational interventions and 8 to therapeutic interventions (Table 2).
In the pilot testing, items with feasibility problems were evidenced for 2 QMs, due to a lack of specific information in medical records. They are indicated in Table 2. For example, this occurred in the QM 'Surgery intervention in patients who were symptomatic after a minimum of 6–12 months of conservative therapies' because pain assessment was not measurable on some patients. Reliability indexes are displayed in Table 2 for each potential indicator.
All indexes indicated substantial to excellent agreement.
Brief descriptions of the literature that supports the criterion of quality for each of the indicators are provided below.
Physical Examination Patients with cervical radiculopathy, proximal neurovascular entrapment and radial tunnel syndrome may complain of the same symptoms as patients with LE. However, there is no "gold standard" for the diagnosis of LE, and orthopaedic tests such as pain with resisted wrist extension (Cozen's sign) are traditionally recommended for differential diagnosis.
Pain and Functional Assessment The literature review failed to identify clinical studies that evaluated relations between outcomes and assessment of pain or functional limitations. However, because improvement of pain and function are two primary goals in the treatment of LE, it seems that these parameters are essential for clinical decision making.
A variety of factors, such as force, repetition, posture and specific combined elbow exposure, such as combined elbow flexion/extension, wrist bending and perceived physical exertion may lead to LE. These factors are not only risk factors for developing LE, but also indicators of poor prognosis and prevention. For prevention, patient education is important to reduce the ergonomic risk.
The literature search identified 3 published studies for the effectiveness of patient education on pain and disability among individuals with LE, all of which shared similar conclusions. The most recent paper concluded that a structured physiotherapy treatment programme, that included ergonomic advice, was more effective than corticosteroid injections and NSAIDs, the major findings being that the intervention group had less pain than patients treated with corticosteroid injections or NSAIDs and experienced better function than those treated with corticosteroid injections. Furthermore, the intervention group had a lower recurrence and fewer sick leave days.
First Line Non-steroidal anti-inflammatory drugs (NSAIDs) via oral administration have been used extensively for many years to treat pain associated with LE. There is some evidence for a short term benefit of NSAIDs (2 weeks) with a decrease of pain and function, but this benefit was not sustained. However, there is little evidence to support the use of oral NSAIDs in the long term.
Prophylaxis of Gastrointestinal Bleedings (GI) Numerous RCTs and meta-analyses have demonstrated that NSAIDs are associated with a greater risk of GI bleedings. Exposure to NSAIDs has been associated with a 2.2 to 5.4 greater risk of various adverse GI events. A variety of factors such as older age (age ≥75), peptic ulcer disease, history of adverse GI events, and concomitant therapy with anticoagulants or corticosteroids, may exacerbate the NSAID-associated risk for GI toxicity. One meta-analysis of 112 RCTs found that gastroprotective strategies such as proton pump inhibitor (PPI) reduce the risk of symptomatic ulcers, and misoprostol reduces the risk of serious GI complications.
First Line
Therapeutic Exercises Numerous RCTs have evaluated the effects of exercise on LE. Four SRs reached similar conclusions. The most recent SR evaluated the effect of different exercises in LE on pain and disability. Of the 12 included studies, 9 addressed the effects of isotonic (eccentric/concentric) exercises, 2 studied the effect of isometrics and one studied isokinetic exercises. All studies reported that resistance exercises resulted in substantial improvement in pain and grip strength.
The most recent RCT evaluated the short-term effects of daily eccentric exercises on functional pain-free hand strength in subjects with long-term LE. The exercise program included 2×8–12 repetitions once a day during the first week, while the instruction for the following 2 weeks was to progress to twice daily. At the end of the intervention, the exercise group had significantly higher pain-free hand-grip strength and higher pain-free hand-extensor strength, and in the exercise group the proportion of cases with LE decreased by 66% at the end of the intervention, whereas in controls they decreased by 21%.
Manual Therapy One SR showed that lateral-glide mobilization with movement technique had positive effects for pain relief and restoration of function in patients with LE. One RCT studied the effect of applied mobilization techniques using a program of six repetitions performed with a 15 second rest interval between repetitions. This study demonstrated a significant and substantial increase in painfree grip strength of 58% (of the order of 60 Newton) in the treatment group but not in the placebo or control.
Laser Therapy The most recent meta-analysis assessed the clinical effectiveness of Low Level Laser Therapy (LLLT), the relevance of irradiation parameters to outcomes, and the validity of current dosage recommendations for the treatment of tendinopathy. The review included 25 relevant studies, 13 investigated the effectiveness of LLLT for LE of which 6 showed positive results. As summarized, the positive results evidenced a recommended dosage for the management of LE which was a wavelength of 904 nm and power densities that lay between 2–100 mW/cm.
NSAIDs are usually prescribed for 2 weeks, and corticosteroid injections are often used if treatment by oral medication and other non-operative interventions have failed. Often, physical therapy is a first option to referral when they are not effective. There is no available evidence of an adequate time of referral after oral NSAIDs; however, the evidence to-date suggests that early multimodal programmes of physical therapy should be recommended after corticosteroid injections.
A RCT supported that the combined approach is preferred to that of injection alone. This study demonstrated that a physical therapy program 1–2 weeks following injection comprising education, 8 sessions of manual therapy techniques (Mobilization With Movement), concentric-eccentric exercises and active home exercises improved the long term efficacy and reduced the recurrence rates. The, benefits gained by adding physiotherapy to injection outweighed the costs associated with injection alone, furthermore the cost-effectiveness of the combined therapy was superior to the cost-effectiveness of injection alone.
Platelet-rich Plasma (PRP) There is a growing body of supporting evidence for this conservative approach, mainly for patients with LE with refractory symptoms after physical therapy management. Four SRs have described the clinical efficacy and risk of adverse events of PRP for treatment of LE. The most recent meta-analysis identified that the effects of PRP injections were statistically superior to placebo. Regarding the injection method, the recommendations were to collect an amount of 25 ml of autologous blood to obtain an average of 3.5 cc of plasma, and it was not deemed necessary to use calcium or thrombin prior activation of platelets. For the injection technique it was recommended to perform the infiltration into the extensor digitorum communis tendon using the peppering technique.
Surgery Four SRs have studied the effectiveness of surgical treatment for LE and they reported similar conclusions. Surgical options (percutaneous, open and arthroscopic techniques) were effective and safe interventions in relieving pain and restoring function in cases where non-operative approaches failed. However, these studies were unable to support the superiority of one surgical procedure over another.
Results
Table 1 includes the recommendations identified in the first phase, and their evidence level and strength. None were based on CPG. From these recommendations, a total of 12 potential QMs were created and accepted for the pilot testing: 3 were related to assessment interventions, 1 to educational interventions and 8 to therapeutic interventions (Table 2).
Feasibility and Reliability
In the pilot testing, items with feasibility problems were evidenced for 2 QMs, due to a lack of specific information in medical records. They are indicated in Table 2. For example, this occurred in the QM 'Surgery intervention in patients who were symptomatic after a minimum of 6–12 months of conservative therapies' because pain assessment was not measurable on some patients. Reliability indexes are displayed in Table 2 for each potential indicator.
All indexes indicated substantial to excellent agreement.
Supporting Evidence
Brief descriptions of the literature that supports the criterion of quality for each of the indicators are provided below.
Patient Examination
Physical Examination Patients with cervical radiculopathy, proximal neurovascular entrapment and radial tunnel syndrome may complain of the same symptoms as patients with LE. However, there is no "gold standard" for the diagnosis of LE, and orthopaedic tests such as pain with resisted wrist extension (Cozen's sign) are traditionally recommended for differential diagnosis.
Pain and Functional Assessment The literature review failed to identify clinical studies that evaluated relations between outcomes and assessment of pain or functional limitations. However, because improvement of pain and function are two primary goals in the treatment of LE, it seems that these parameters are essential for clinical decision making.
Educational Interventions
A variety of factors, such as force, repetition, posture and specific combined elbow exposure, such as combined elbow flexion/extension, wrist bending and perceived physical exertion may lead to LE. These factors are not only risk factors for developing LE, but also indicators of poor prognosis and prevention. For prevention, patient education is important to reduce the ergonomic risk.
Effectiveness of Patient Education
The literature search identified 3 published studies for the effectiveness of patient education on pain and disability among individuals with LE, all of which shared similar conclusions. The most recent paper concluded that a structured physiotherapy treatment programme, that included ergonomic advice, was more effective than corticosteroid injections and NSAIDs, the major findings being that the intervention group had less pain than patients treated with corticosteroid injections or NSAIDs and experienced better function than those treated with corticosteroid injections. Furthermore, the intervention group had a lower recurrence and fewer sick leave days.
Pharmacological Therapy
First Line Non-steroidal anti-inflammatory drugs (NSAIDs) via oral administration have been used extensively for many years to treat pain associated with LE. There is some evidence for a short term benefit of NSAIDs (2 weeks) with a decrease of pain and function, but this benefit was not sustained. However, there is little evidence to support the use of oral NSAIDs in the long term.
Prophylaxis of Gastrointestinal Bleedings (GI) Numerous RCTs and meta-analyses have demonstrated that NSAIDs are associated with a greater risk of GI bleedings. Exposure to NSAIDs has been associated with a 2.2 to 5.4 greater risk of various adverse GI events. A variety of factors such as older age (age ≥75), peptic ulcer disease, history of adverse GI events, and concomitant therapy with anticoagulants or corticosteroids, may exacerbate the NSAID-associated risk for GI toxicity. One meta-analysis of 112 RCTs found that gastroprotective strategies such as proton pump inhibitor (PPI) reduce the risk of symptomatic ulcers, and misoprostol reduces the risk of serious GI complications.
Physical Therapy
First Line
Therapeutic Exercises Numerous RCTs have evaluated the effects of exercise on LE. Four SRs reached similar conclusions. The most recent SR evaluated the effect of different exercises in LE on pain and disability. Of the 12 included studies, 9 addressed the effects of isotonic (eccentric/concentric) exercises, 2 studied the effect of isometrics and one studied isokinetic exercises. All studies reported that resistance exercises resulted in substantial improvement in pain and grip strength.
The most recent RCT evaluated the short-term effects of daily eccentric exercises on functional pain-free hand strength in subjects with long-term LE. The exercise program included 2×8–12 repetitions once a day during the first week, while the instruction for the following 2 weeks was to progress to twice daily. At the end of the intervention, the exercise group had significantly higher pain-free hand-grip strength and higher pain-free hand-extensor strength, and in the exercise group the proportion of cases with LE decreased by 66% at the end of the intervention, whereas in controls they decreased by 21%.
Manual Therapy One SR showed that lateral-glide mobilization with movement technique had positive effects for pain relief and restoration of function in patients with LE. One RCT studied the effect of applied mobilization techniques using a program of six repetitions performed with a 15 second rest interval between repetitions. This study demonstrated a significant and substantial increase in painfree grip strength of 58% (of the order of 60 Newton) in the treatment group but not in the placebo or control.
Laser Therapy The most recent meta-analysis assessed the clinical effectiveness of Low Level Laser Therapy (LLLT), the relevance of irradiation parameters to outcomes, and the validity of current dosage recommendations for the treatment of tendinopathy. The review included 25 relevant studies, 13 investigated the effectiveness of LLLT for LE of which 6 showed positive results. As summarized, the positive results evidenced a recommended dosage for the management of LE which was a wavelength of 904 nm and power densities that lay between 2–100 mW/cm.
Time of Referral
NSAIDs are usually prescribed for 2 weeks, and corticosteroid injections are often used if treatment by oral medication and other non-operative interventions have failed. Often, physical therapy is a first option to referral when they are not effective. There is no available evidence of an adequate time of referral after oral NSAIDs; however, the evidence to-date suggests that early multimodal programmes of physical therapy should be recommended after corticosteroid injections.
A RCT supported that the combined approach is preferred to that of injection alone. This study demonstrated that a physical therapy program 1–2 weeks following injection comprising education, 8 sessions of manual therapy techniques (Mobilization With Movement), concentric-eccentric exercises and active home exercises improved the long term efficacy and reduced the recurrence rates. The, benefits gained by adding physiotherapy to injection outweighed the costs associated with injection alone, furthermore the cost-effectiveness of the combined therapy was superior to the cost-effectiveness of injection alone.
Other Therapeutic Interventions
Platelet-rich Plasma (PRP) There is a growing body of supporting evidence for this conservative approach, mainly for patients with LE with refractory symptoms after physical therapy management. Four SRs have described the clinical efficacy and risk of adverse events of PRP for treatment of LE. The most recent meta-analysis identified that the effects of PRP injections were statistically superior to placebo. Regarding the injection method, the recommendations were to collect an amount of 25 ml of autologous blood to obtain an average of 3.5 cc of plasma, and it was not deemed necessary to use calcium or thrombin prior activation of platelets. For the injection technique it was recommended to perform the infiltration into the extensor digitorum communis tendon using the peppering technique.
Surgery Four SRs have studied the effectiveness of surgical treatment for LE and they reported similar conclusions. Surgical options (percutaneous, open and arthroscopic techniques) were effective and safe interventions in relieving pain and restoring function in cases where non-operative approaches failed. However, these studies were unable to support the superiority of one surgical procedure over another.