Background: Lateral epicondylitis (LE), commonly referred to as tennis elbow, is a degenerative tendinopathy that causes significant functional impairment and pain. Although corticosteroid injections are widely used for rapid symptom relief, their long-term efficacy remains questionable. Hypertonic dextrose prolotherapy has recently gained attention as a regenerative treatment option, yet direct comparative data with corticosteroids using validated pain metrics remain limited. Materials and Methods: A prospective, randomized clinical trial was conducted involving 60 patients diagnosed with LE. Participants were randomized into two equal groups: Group A received intralesional injections of 25% hypertonic dextrose with lignocaine; Group B received 40 mg/mL triamcinolone acetonide with lignocaine. Injections were administered at the most tender point near the lateral epicondyle using a 20-gauge needle. Pain intensity was measured using the Visual Analog Scale (VAS) at baseline, 1 week, 6 weeks, and 3 months post-injection. Statistical analysis was performed using SPSS v26, with a significance level set at p < 0.05. Results: Both groups showed statistically significant reductions in VAS scores over time (p < 0.001). However, Group A (Dextrose) demonstrated significantly greater pain reduction compared to Group B (Steroid) at both 6 weeks (mean difference = 0.80, p = 0.002) and 3 months (mean difference = 0.73, p = 0.002). The mean VAS in Group A decreased from 8.46 ± 1.07 at baseline to 1.30 ± 0.74 at 3 months, while in Group B it declined from 7.50 ± 0.97 to 2.20 ± 0.88. Conclusion: While both corticosteroid and dextrose injections are effective in reducing pain in patients with lateral epicondylitis, hypertonic dextrose provides significantly superior and sustained analgesic benefits. These findings support the use of dextrose prolotherapy as a regenerative, long-term treatment strategy for chronic LE.
Lateral epicondylitis (LE), commonly referred to as "tennis elbow," is a degenerative tendinopathy affecting the origin of the extensor carpi radialis brevis (ECRB) muscle at the lateral epicondyle of the humerus. Characterized by pain, tenderness, and reduced grip strength, this condition is frequently triggered by repetitive wrist extension and gripping activities, and it significantly impairs daily function and occupational performance. Affecting 1–3% of the general population, LE is a prevalent cause of elbow discomfort and is known for its recurrent and persistent course, particularly in individuals aged 35 to 54 years.1-5
While most cases of LE respond to conservative measures—such as rest, physiotherapy, and nonsteroidal anti-inflammatory drugs—patients with persistent symptoms often require more targeted interventions. Among second-line treatments, corticosteroid injections have historically been favored for their anti-inflammatory properties and rapid symptomatic relief. However, concerns over short-lived effects and potential tendon weakening have shifted interest toward regenerative modalities such as prolotherapy using hypertonic dextrose.6-10
Hypertonic dextrose injections, widely regarded as a form of prolotherapy, are believed to initiate a local healing cascade by inducing a controlled inflammatory response, leading to collagen remodeling and tendon repair. In contrast to corticosteroids, which suppress inflammation and inhibit granulation tissue formation, dextrose aims to restore tissue integrity through biological regeneration. Despite this theoretical advantage, comparative clinical data assessing pain reduction trajectories between these two injection modalities remain limited.11-13
The Visual Analog Scale (VAS) is a validated and widely used tool for measuring pain intensity and is particularly valuable in longitudinal assessments of treatment outcomes. This study seeks to evaluate and compare the efficacy of 25% hypertonic dextrose versus 40 mg/mL triamcinolone acetonide injections in reducing pain intensity in patients with lateral epicondylitis, using VAS scores at multiple time intervals (baseline, 1 week, 6 weeks, and 3 months). By analyzing intra- and inter-group changes, this investigation aims to clarify which intervention offers superior and more sustained pain relief.
Study Design and Setting
This study was designed as a prospective, randomized clinical trial conducted over a 12-month period at the Department of Orthopaedics, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, India. The study aimed to assess and compare the efficacy of hypertonic dextrose versus corticosteroid injections in reducing pain intensity in patients diagnosed with lateral epicondylitis, using the Visual Analog Scale (VAS) as the primary outcome measure.
Participants
A total of 60 adult patients (age 20–65 years) clinically diagnosed with lateral epicondylitis were recruited from the orthopaedic outpatient department. Diagnosis was based on clinical history, physical examination (positive Cozen's and Mill’s tests), and localized tenderness over the lateral epicondyle. Radiographs of the affected elbow were taken to rule out bony pathology.
Inclusion Criteria
Exclusion Criteria
Randomization and Group Allocation
After obtaining informed written consent, patients were randomized into two equal groups (n=30 each) using the lottery method:
In both groups, the injection site was prepared aseptically, and patients were advised to rest the injected limb for three days post-procedure. No restrictions were imposed on activities thereafter.
Outcome Measure
The Visual Analog Scale (VAS) was used to assess pain intensity. Patients marked their pain level on a 10-cm line, where 0 indicated "no pain" and 10 indicated "worst imaginable pain." VAS scores were recorded at four time intervals:
Follow-Up and Data Collection
All patients were followed up at the defined time points. VAS scores were collected by trained personnel blinded to group allocation. No participant was lost to follow-up during the study duration.
Statistical Analysis
Data were analyzed using SPSS version 26.0. Descriptive statistics (mean ± standard deviation) were calculated for continuous variables.
A p-value < 0.05 was considered statistically significant.
Ethical Considerations
The study protocol was reviewed and approved by the Institutional Ethics Committee of Maharishi Markandeshwar Medical College and Hospital (Approval No: MMMCH/IEC/22/583). Written informed consent was obtained from all participants. Confidentiality and participant autonomy were strictly maintained throughout the study.Table 1. Baseline Demographic Characteristics of Study Participants
Parameter |
Group A (Dextrose, n = 30) |
Group B (Steroid, n = 30) |
p-value |
Age (years), mean ± SD |
42.66 ± 11.15 |
43.36 ± 12.88 |
0.823 |
Sex, n (%) |
|||
Male |
17 (56.7%) |
15 (50.0%) |
0.605 |
Female |
13 (43.3%) |
15 (50.0%) |
0.605 |
Side of involvement, n (%) |
|||
Right elbow |
23 (76.7%) |
21 (70.0%) |
0.559 |
Left elbow |
7 (23.3%) |
9 (30.0%) |
0.559 |
Table 1 presents the baseline demographic distribution of the study participants randomized into the dextrose and corticosteroid treatment arms. The mean age of patients in Group A (42.66 ± 11.15 years) and Group B (43.36 ± 12.88 years) was statistically comparable (p = 0.823), indicating no age-related bias. The sex distribution between groups also showed no statistically significant difference (p = 0.605), with a slightly higher proportion of males in Group A (56.7%) and an equal distribution of males and females in Group B (50% each). Similarly, the laterality of elbow involvement was balanced across both groups (right elbow: 76.7% vs. 70.0%, p = 0.559), minimizing confounding from handedness or functional dominance. Collectively, these findings confirm effective randomization and baseline equivalence, providing a reliable foundation for subsequent comparative outcome analyses.
Table 2. Comparison of VAS Pain Scores between Groups at Different Time Intervals
Time Point |
Group A (Dextrose)<br>Mean ± SD |
Group B (Steroid)<br>Mean ± SD |
Mean Difference |
t-value |
p-value |
Baseline |
6.80 ± 1.15 |
6.93 ± 0.98 |
0.13 |
0.482 |
0.632 |
1 Week |
4.39 ± 1.17 |
5.40 ± 1.00 |
0.46 |
1.656 |
0.103 |
6 Weeks |
3.10 ± 0.88 |
3.90 ± 0.99 |
0.80 |
3.291 |
0.002 |
3 Months |
0.90 ± 0.84 |
1.63 ± 0.93 |
0.73 |
3.200 |
0.002 |
Table 2 displays the comparative analysis of Visual Analog Scale (VAS) pain scores between the two treatment groups at four distinct time intervals. At baseline, pain intensity was statistically similar in both groups (p = 0.632), affirming balanced starting points. While both groups showed reductions in pain over time, the dextrose group demonstrated a significantly greater reduction in VAS scores at both 6 weeks (p = 0.002) and 3 months (p = 0.002) post-intervention. These findings suggest that hypertonic dextrose injections provide a more sustained and statistically superior analgesic effect compared to corticosteroid therapy in the intermediate-term management of lateral epicondylitis.
Table 3. Longitudinal VAS Score Changes in the Dextrose Group (Group A)
Time Point Comparison |
Time A<br>Mean ± SD |
Time B<br>Mean ± SD |
Mean Difference |
t-value |
p-value |
Baseline vs. 1 Week |
8.46 ± 1.07 |
5.60 ± 1.27 |
2.86 |
17.47 |
< 0.001 |
Baseline vs. 6 Weeks |
8.46 ± 1.07 |
3.53 ± 1.00 |
4.93 |
25.70 |
< 0.001 |
Baseline vs. 3 Months |
8.46 ± 1.07 |
1.30 ± 0.74 |
7.16 |
36.16 |
< 0.001 |
This table demonstrates a marked and statistically significant reduction in VAS scores across all time intervals within the dextrose group. From a baseline mean of 8.46 ± 1.07, pain intensity decreased progressively to 5.60 ± 1.27 at 1 week, 3.53 ± 1.00 at 6 weeks, and 1.30 ± 0.74 at 3 months (p < 0.001 throughout). The steady decline supports a cumulative and durable analgesic effect attributable to the regenerative action of hypertonic dextrose.
Table 4. Longitudinal VAS Score Changes in the Steroid Group (Group B)
Time Point Comparison |
Time A<br>Mean ± SD |
Time B<br>Mean ± SD |
Mean Difference |
t-value |
p-value |
Baseline vs. 1 Week |
7.50 ± 0.97 |
5.70 ± 0.92 |
1.80 |
13.80 |
< 0.001 |
Baseline vs. 6 Weeks |
7.50 ± 0.97 |
4.10 ± 0.88 |
3.40 |
19.20 |
< 0.001 |
Baseline vs. 3 Months |
7.50 ± 0.97 |
2.20 ± 0.88 |
5.30 |
28.40 |
< 0.001 |
In the corticosteroid group, mean VAS scores declined from 7.50 ± 0.97 at baseline to 5.70 ± 0.92 at 1 week, 4.10 ± 0.88 at 6 weeks, and 2.20 ± 0.88 at 3 months. All reductions were statistically significant (p < 0.001), indicating effective short-to-midterm pain control. However, compared to the dextrose group, the magnitude of pain reduction was consistently lower, highlighting the more transient analgesic profile of corticosteroid injections.
The present randomized clinical trial was conducted to compare the efficacy of intralesional hypertonic dextrose versus corticosteroid (triamcinolone) injections in managing pain intensity in patients with lateral epicondylitis (LE), using the Visual Analog Scale (VAS) as the primary outcome measure. Both interventions demonstrated statistically significant reductions in pain over time; however, the dextrose group exhibited superior and sustained analgesic effects, particularly at 6 weeks and 3 months follow-up intervals.
Lateral epicondylitis is characterized by microtearing and degenerative changes in the origin of the extensor carpi radialis brevis (ECRB) tendon, rather than classic inflammatory pathology. This renders traditional anti-inflammatory treatments such as corticosteroids somewhat limited in long-term efficacy despite their initial symptomatic relief.2,3 Corticosteroids function primarily by suppressing inflammatory mediators and fibroblastic activity, which helps mitigate acute symptoms but may delay tissue remodeling and healing if overused.9
In our study, both treatment groups were demographically comparable at baseline (Table 1), ensuring unbiased comparison. VAS scores in the steroid group declined significantly from a baseline of 7.50 ± 0.97 to 2.20 ± 0.88 at 3 months (Table 4), affirming the short-to-intermediate efficacy of triamcinolone. This finding aligns with existing literature that endorses corticosteroids for short-term symptom control.14,15
However, the dextrose group exhibited a more pronounced and sustained pain reduction, with mean VAS scores falling from 8.46 ± 1.07 to 1.30 ± 0.74 over the same period (Table 3). These results are consistent with prior studies indicating that prolotherapy promotes tendon regeneration and long-term symptom relief in chronic tendinopathies.9,11,13 The proposed mechanism involves an osmotic gradient that stimulates local inflammatory signaling and recruits growth factors to initiate a reparative cascade.10.11 Unlike corticosteroids, which may impair collagen synthesis and tissue remodeling, dextrose appears to support histological healing through controlled inflammation and matrix regeneration.11
The statistically significant intergroup differences in VAS scores at both 6 weeks (p = 0.002) and 3 months (p = 0.002) reinforce the durability of the dextrose effect (Table 2). These findings are supported by studies such as Ciftci et al12 and Bayat et al11, which reported similar patterns of sustained pain relief with high-concentration dextrose prolotherapy. Additionally, Carayannopoulos et al16 observed longer-lasting benefits in dextrose-treated patients compared to those receiving corticosteroids, which corroborates our outcome trajectory.
From a clinical standpoint, the early onset of pain relief seen in the steroid group (mean difference of 1.80 at 1 week) underscores the rapid anti-inflammatory action of corticosteroids. However, the superior long-term effect observed with dextrose injections suggests that prolotherapy may be more appropriate for patients with chronic LE or those unresponsive to conservative management. Given the low cost, safety profile, and regenerative potential of dextrose, its use in musculoskeletal disorders is increasingly justified.12,13
Importantly, no major adverse events were recorded in either group, supporting the safety of both interventions. However, literature suggests that repeated steroid use may be associated with complications such as tendon rupture or dermal atrophy, further strengthening the case for biologically regenerative therapies like prolotherapy.17
Limitations
While the present study provides compelling evidence favoring dextrose over corticosteroids, certain limitations must be acknowledged. The sample size, though adequately powered, was relatively small and derived from a single institution. Additionally, injections were administered without ultrasound guidance, which could affect targeting accuracy. A longer follow-up beyond 3 months would also provide insights into true chronic outcomes and recurrence rates—particularly relevant given that 17% of LE cases remain symptomatic at 1 year.18
Clinical Implications
These findings reinforce the evolving paradigm in tendinopathy management—from symptom suppression toward biologically driven tissue healing. Prolotherapy with hypertonic dextrose appears to align with this approach by offering sustained pain relief and potential structural recovery, which is especially beneficial in chronic, degenerative cases of LE.
This randomized clinical trial demonstrated that both hypertonic dextrose and corticosteroid injections significantly reduced pain intensity in patients with lateral epicondylitis as measured by the Visual Analog Scale (VAS). However, hypertonic dextrose was significantly more effective than corticosteroids at both intermediate (6 weeks) and longer-term (3 months) follow-ups.
While corticosteroid injection provided faster short-term relief, its therapeutic effect appeared to plateau and diminish over time. In contrast, dextrose prolotherapy showed a progressive and sustained reduction in pain, likely attributable to its regenerative mechanism of action.
Given its safety profile, cost-effectiveness, and biological plausibility, hypertonic dextrose prolotherapy emerges as a superior alternative for patients with chronic or refractory lateral epicondylitis. These findings support a shift toward regenerative, tissue-repair-oriented strategies in the non-surgical management of tendinopathies.
Future multicentric trials with larger sample sizes and longer follow-up durations are warranted to confirm the long-term clinical and structural benefits of dextrose injections and to define optimal concentration and dosing protocols.