Abstract
BACKGOUND:
Lateral epicondylitis (LE) is one of the most common musculoskeletal disorders that causes pain.
OBJECTIVES:
We evaluated the effect of the inclusion of a minimal dose of corticosteroid in a solution comprising autologous whole blood (AWB), 20% dextrose, and 2% lidocaine for treating LE.
METHODS:
In this randomized prospective trial LE patients were allocated to the CS
RESULTS:
In the CS
CONCLUSIONS:
The inclusion of a minimal dose of corticosteroid in the AWB and 20% dextrose injection can reduce pain, especially during early treatment.
Introduction
Lateral epicondylitis (LE) is one of the most common musculoskeletal disorders that causes pain and occurs in 1–3% of the general population each year [1]. The site of pain is the lateral part of the elbow, and this pain is aggravated when extending the wrist joint and lifting objects [2, 3]. LE-related pain can cause disability and impact a patient’s emotional state [4]. Corticosteroid injection is the most common treatment for LE [5, 6]. However, corticosteroid injection only has a short-term pain-reducing effect and can induce several adverse effects, such as fat atrophy, tendon tear, and hypothalamic-pituitary-adrenal axis deterioration [7, 8]. In addition, as LE is a degenerative disorder, regeneration-inducing treatments are more appropriate than corticosteroid injections.
Recently, the injection of autologous blood products (ABPs) has been suggested as an alternative treatment for LE [9, 10, 11]. ABPs include autologous whole blood (AWB) and platelet-rich plasma (PRP), both of which contain growth factors that can aid the healing of injured soft tissues [10]. Although centrifugation is required to isolate and concentrate platelets for the preparation of PRP, no preparation is necessary for AWB injections. Several previous studies have demonstrated the pain-reducing effect of AWB injections [6, 9, 11].
Prolotherapy is a regenerative or proliferative therapy [12, 13]. The primary principle of prolotherapy is the injection of a relatively small volume of an irritant or sclerosing solution in painful ligaments or tendons [14]. Among the solutions available for prolotherapy, hypertonic dextrose is the most commonly used in clinical practice because it is inexpensive and induces few adverse effects. Hypertonic dextrose induces the osmotic rupture of tissue cells, which results in the release of growth factors, neovascularization, and sclerosis [15, 16, 17, 18]. These phenomena induce the healing of damaged tissue and reduce musculoskeletal disorder-associated pain.
However, during and after AWB injection or prolotherapy, patients experience moderate pain and soreness. For prolotherapy, injections should be administered every 2–6 weeks, and some patients might abstain from treatment in the middle of the prolotherapy course. Low-dose corticosteroid injections provide immediate and short-term pain relief [19]. Therefore, we propose that they may enhance patient compliance and increase the pain-reducing effect of AWB injection and prolotherapy. In the current study, we evaluated the effect of the inclusion of a minimal dose of corticosteroid (0.1 mL of dexamethasone palmitate) in a solution comprising 1 mL of AWB, 1 mL of 20% dextrose, and 0.4 mL of 2% lidocaine for treating patients with LE.
Methods
Patients
This single-center, prospective, randomized, comparative study was conducted in an outpatient pain clinic. We included 140 consecutive patients who met the following inclusion criteria: 1)
Subject demographics and baseline clinical data
Subject demographics and baseline clinical data
The values presented are numbers or the mean
The patients were blinded to the treatments. The injection was administered under ultrasound guidance (Venue 50, GE Healthcare, Seoul, Republic of Korea) with the subject in the supine position (Fig. 1). The patients in the CS
A solution comprising 1 mL of AWB, 1 mL of 20% dextrose, 0.4 mL of 2% lidocaine, and 0.1 mL of dexamethasone palmitate was administered under ultrasound guidance into the common wrist extensor tendon.
All outcome assessments were performed by a single investigator who was blinded to the group allocation and did not participate in any treatment. The primary outcome was pain intensity, and the secondary outcome was grip strength. Pain intensity was measured using the NRS (0 indicated no pain and 10 was the worst imaginable pain; range: 0–10). Current pain intensity in the relaxed hand was measured immediately before each injection on the first to fifth visits. In addition, current pain intensity was measured 6 months (the sixth visit) after the fifth injection. The average monthly pain intensity calculated from the second to the fifth visit was also evaluated.
In addition to the NRS score, grip strength (in kg) was measured using a hand-grip dynamometer (MSD Europe Bvba, Belgium) when the patient was in the sitting position (from the first to the fifth visit). The subjects were asked to grip the dynamometer with their hand on the affected side and apply maximum force. The maximum values from the three tests were recorded. A 1-minute rest period was allowed between each trial. During each trial, the investigator encouraged the patients to grip the dynamometer with maximum force.
Statistical analysis
The data were analyzed using SPSS (version 24.0; IBM Corporation, Armonk, NY, USA). Demographic data were compared between the groups using the independent
Results
Demographic data, including age, sex, symptom duration, initial NRS, and initial grip strength were not significantly different between the CS
Regarding the primary outcome (pain intensity), the current pain intensities in the relaxed hand at the first to the fifth visit and 6 months after the last injection were significantly different over time in both the CS
Current pain intensity (numeric rating scale score) in the relaxed hand measured just before the injection from the to the first to the fifth visit and 6 months after the last injection (6th visit)
Current pain intensity (numeric rating scale score) in the relaxed hand measured just before the injection from the to the first to the fifth visit and 6 months after the last injection (6th visit)
Average pain intensity (numeric rating scale score) during the 1 month between each visit from the second to the fifth visit
The average monthly pain intensity from the second to the fifth visit was significantly different over time in both the CS
Grip strength, the secondary outcome, increased significantly over time. Grip strengths measured just before the injection at the first to fifth visits were significantly different over time in both the CS
Grip strength (in kg) measured just before the injection from the first to the fifth visit and 6 months after the last injection (sixth visit)
In this study, we evaluated the effect of the addition of a minimal dose of corticosteroid to a mixture of AWB and 20% dextrose for treating LE patients.
NRS scores were significantly reduced after the injection of AWB and 20 mL of dextrose, regardless of the inclusion of a minimal dose of corticosteroid. Once the entire treatment course (five injections) was completed, the painreducing effect was sustained for at least 6 months. The current pain intensity in the relaxed arm was significantly lower in the CS
In addition, a greater reduction in average pain intensity was observed in the CS
Grip strength increased following injection. However, the degree of increase in grip strength did not differ between groups. Grip strength increases when the wrist extension position is between 15
AWB and prolotherapy activate tendon repair and regeneration by recruiting growth factors and growth hormones, stimulating fibroblast proliferation, migration and collagen production, and inducing angiogenesis [10, 15, 16, 17, 18]. The healing of the degenerated common wrist extensor tendon appears to result in a reduction in LE-related pain. We mixed 0.1 mL of dexamethasone palmitate with the 2.4-milliliter solution containing AWB, 20% dextrose, and 2% lidocaine and injected 0.2–1 mL of this solution. Therefore, the total injected dose of dexamethasone was 0.032–0.16 mg. Corticosteroids have a strong anti-inflammatory effect; accordingly, they hinder the secretion and action of growth factors and hormones [24] and may induce tendon rupture [7]. However, in our study, the dose of dexamethasone injected was extremely low. Therefore, the corticosteroid did not significantly interfere with the regeneration of the degenerated tendon. Instead, it reduced pain during the early period of treatment.
Several studies have shown the positive pain-reducing effect of AWB and prolotherapy with 20% dextrose in LE patients [25, 26, 27, 28, 29, 30]. The short-term pain-reducing effects of AWB and prolotherapy with 20% dextrose were lower than those of corticosteroid; however, the injection of AWB or prolotherapy with 20% dextrose is more efficacious than that of corticosteroids over longer periods [5, 11]. In our study, we injected AWB and 20% dextrose, which effectively managed LE-related pain.
Our study had some limitations. First, we did not include a control or placebo group. Second, the age range of the included patients was relatively large. Third, the level of habitual physical activity of each patient was not considered. Fourth, the handgrip strength of the uninvolved hand of the patients was not assessed. Fifth, we did not consider which hand was dominant for each patient. Sixth, when interpreting the results of grip strength, the difference in sex ratio between groups was not considered. Finally, we did not confirm regeneration of the common wrist extensor tendon. Further studies are required to address these limitations.
Conclusion
In our study on patients with LE, the inclusion of a minimal dose of corticosteroid during AWB and 20% dextrose injection reduced pain, especially during the early treatment period. Thus, our results suggest that the inclusion of a minimal dose of corticosteroid reduces the pain induced by AWB injection and prolotherapy. To the best of our knowledge, this study is the first to investigate the effect of the addition of a minimal dose of corticosteroid to the injection solution for tissue regeneration.
Footnotes
Acknowledgments
This study was supported by National Research Foundation of Korea Grant funded by the Korean government (Grant no. NRF-2021R1A2C1013073).
Conflict of interest
None of the authors have any conflicts of interest to report.
