Abstract
Objective
The study aimed to compare the effects of a combined intervention of dry needling and eccentric exercises versus oral and topical NSAID treatment, each combined with eccentric exercises, on pain intensity and hand function in patients with lateral epicondylalgia.
Design
A single-blind, randomized controlled trial.
Methods
A total of 111 participants with LE were randomly assigned to three groups: Dry needling plus eccentric exercise, Oral treatment plus eccentric exercise, and Topical treatment plus eccentric exercise. Pain intensity was assessed using the Visual Analog Scale and pressure pain threshold at the lateral epicondyle, medial epicondyle, radial styloid, and ulnar styloid. Functional impairment was measured using the HAND10 questionnaire. Statistical analysis included repeated measures ANOVA and post-hoc tests.
Results
All groups showed significant improvements in pain intensity and function over the 30-day intervention period The DN group achieved the most substantial reduction in pain and the greatest improvement in pressure pain threshold and functional scores, followed by the TopA group. The OralI group demonstrated the least improvement across all measures. Significant differences were found between the three groups,with the dry needling group outperforming both Oral and Topical treatment groups in pain relief and functional outcomes.
Conclusion
The combination of dry needling and eccentric exercises was more effective in reducing pain and improving hand function compared to NSAID-based interventions. These findings support the use of dry needling as an adjunct therapy to eccentric exercises for the management of lateral epicondylalgia.
Introduction
Lateral epicondylalgia (LE) had been related to sporting activities, hence its name “tennis elbow”. The prevalence of LE is between 1% and 3% of the general population.This proportion is increased by 15% in workers who perform repetitive manual tasks.1,2 LE affects all age groups, but predominantly affects people between 30 and 60 years of age.3,4 Pain is usually localized around the lateral epicondyle of the humerus, extending to the dorsal and radial levels of the forearm and increasing with elbow extension combined with forearm rotation, resisted wrist extension, extension of the second and third fingers, and grasping and lifting, 5 mainly in activities or jobs that require strength (sports such as tennis or jobs as office workers, homemakers…) or a resisted extension of the wrist.6,7
Within physiotherapy, there are several techniques to be performed on a patient with LE, such as: manual therapy, orthosis, laser, ultrasound, shock waves, exercise, dry needling and multimodal programs. 8
Dry needling for myofascial trigger points is expected to reduce pain and muscle tension more effectively than treatments that do not include dry needling. 9 In addition, eccentric exercises have been explored by several authors as a way to contribute to greater functional improvement by strengthening and lengthening the muscles. 10 The synergy between these two interventions may offer a more comprehensive and effective therapeutic approach, providing superior benefits in terms of pain relief and functional recovery in patients with epicondylalgia
Pharmacological treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) is considered a common first-line therapy for lateral epicondylitis (LE), aiming to reduce pain and inflammation associated with the condition, 11 although this can vary depending on each country. When oral NSAIDs are not possible or preferred, topical gels containing NSAIDs, such as diclofenac, are often applied for localized relief with fewer systemic side effects. 12 The aim of this study is to study the effects of combination of dry needling and eccentric exercise in pain and hand function compared to either oral intake or topic application of conventional pharmacological treatment (NSAID) also combined with eccentric exercise.
Materials and Methods
Study Design
A single-blind randomized controlled clinical trial was conducted between March and May 2024. All participants signed an informed consent form in accordance with the Declaration of Helsinki before the start of the study. The Research Ethics Committee of the Nuestra Señora de Sonsoles Hospital provided the necessary ethical approval (Approval Code: GASAV/2023/44). The trial has been registered in the Clinical Trials Registry under number NCT05021354. The trial will be conducted according to the CONSORT guidelines for clinical trials. 13
Participants were selected from various health centers in the province of Ávila, following these inclusion criteria: patients aged over 18 and under 65, medically diagnosed with lateral epicondylalgia, reporting pain equal to or greater than 4 on the Visual Analog Scale (VAS) when palpating the lateral epicondyle, and committing to attend follow-ups and assessments during the study period. Patients with a history of recent elbow surgery, rheumatological or neurological diseases, recent cardiovascular events, cancer, diagnosed with fibromyalgia, or infectious processes were excluded.
Participants were randomly assigned to three groups: 1) the dry needling plus eccentric exercise group (DN), 2) the pharmacological treatment, via Oral Intake (OralI) plus eccentric exercise group and 3) the pharmacological treatment, via Topical Application (TopA) (Diclofenaco KernPharma 11,6 mg/g., skin gel) plus eccentric exercise group. Participants were randomly assigned to one of the three study groups using a block randomization method with a 1:1:1 allocation ratio. The randomization sequence was computer-generated using OxMar randomization sofware, ensuring a balanced allocation among groups. The sequence was concealed through sequentially numbered, opaque, sealed envelopes to maintain allocation concealment.
To ensure blindness, outcome assessors, who were independent of the allocation process, remained blinded to the participants’ group assignments to minimize assessment bias.
To determine the sample size, G*Power 3.1.9.4 software (University of Kiel, Germany) was used. The required sample size was calculated with a repeated measures ANOVA, considering two measurements, a two-tailed test, an α error of 0.05, a desired statistical power of 80%, and an effect size of 0.64. which is considered large. This large effect size was selected based on previous studies 9 and clinical experience, anticipating substantial clinical differences between interventions .The results indicated that approximately 27 participants per group were needed for a three-group comparison. To compensate for potential losses of 15%, 30 participants per group were planned, resulting in a total goal of 90 participants. A total number of 130 patients were assessed for eligibility. Finally, being conservative about potential losses, 111 patients were recruited for the study and divided into three groups. The reasons for ineligibility and loss of subjects are indicated in the flow diagram (Figure 1).

Flow Chart of the Study.
Outcome Measures
Pain intensity was assessed using the VAS, a validated tool where participants rated their pain on a continuous scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable. This tool was applied to assess pain at four key anatomical points: the lateral epicondyle (LatE), medial epicondyle (ME), radial styloid (RS), and ulnar styloid (US) of the affected arm.
To measure pressure pain sensitivity, pressure algometry was used to assess the pressure pain threshold (PPT) at these anatomical locations, according to the methodology described by Previtali et al.. 14 The evaluator used a standard pressure algometer (FNP 100, Wagner Instruments®) to determine PPT at the LatE, ME, RS, and US of the affected arm. The algometer tip was placed perpendicular to the skin, and pressure was gradually applied at a rate of 1 kg/cm² per second. Patients were instructed to indicate the onset of local or referred pain, and the pressure was stopped when this sensation became painful. Three measurements were taken at separate times, with a 30-s rest between each, and the average was calculated as the reference value. 15
In addition to pain measurements, the HAND10 questionnaire was utilized to evaluate the functional impact of pain on daily activities involving the hand and elbow. 16 The HAND10 consists of 10 items that assess difficulties related to tasks such as gripping, lifting, and fine motor activities. Each item is rated on a scale of 0 to 10, with higher scores indicating greater functional impairment. This questionnaire has been validated as a reliable tool for assessing hand function in clinical populations and has shown strong internal consistency, with a Cronbach's alpha of 0.95. The 10 items are 1) Wash your face with both hands, 2) Do up shirt buttons with both hands, 3) Turn on/ off the faucet with the affected hand, 4) Open a milk carton with both hands, 5) Operate a door knob and open a heavy door with the affected hand, 6) Wash your hair with both hands, 7) Do manual work without too much difficulty, 8) Do you experience difficulties in activities of daily living? 9) How much pain do you have in your affected hand? 10) Do you feel less confident because of your affected hand?
Pre-Treatment Examination
The measurements were conducted by a physiotherapist with over 10 years of experience, who was unaware of which group the patient belonged to.
Intervention Eccentric Exercise Group and Exercise Protocol in All Groups
The 90 patients performed eccentric exercises for the SU and ECRL muscles daily at home from Day 1 to Day 30, three sets of ten repetitions twice a day (morning and evening) with 1 kg weights, as in the study by Rodríguez et al.. 17 To ensure participants adhered to the exercise program properly, they were asked to keep a daily Excel log indicating the day and time of each exercise session and share it with the researchers via Drive.
Ultrasound-Guided Dry Needling (DN)
On Day 1, 30 patients received a single DN session with a disposable stainless-steel needle (0.3 mm × 40 mm, Agupunt, Barcelona, Spain). The quick in-and-out technique described by Hong
18
was used. The procedure was ultrasound-guided on the proximal lateral surface of the forearm in pronation at 5 cm distance from the lateral epicondyle of the humerus,
19
to reduce pain in patients with epicondylalgia, targeting the ECRL and SU muscles (Figure 2; A., B., and C.), alongside the eccentric exercise program. First, the skin was cleaned with 2% Chlorhexidine Aqueous Spray 250 ml, and then the ultrasound-guided needle was inserted into the ECRL (in the patient's pain area) to elicit local twitch responses (LTR) for proper technique. Once the first LTR was obtained, the needle was moved up and down in the muscle at approximately 1 Hz for 25–30 s, then advanced to the SU muscle to repeat the technique
20
(Figure 2; B. and C.). In order to reduce the risk of puncture of the deep branch of the radial nerve in the supinator canal, the location of the nerve within the arcade was detected prior to puncture. The needle was inserted proximally to this point (

Ultrasound-guided Invasive Approach to the ECRL and SU. Probe Position and Needle Entry Direction at 5 cm (*) from the Lateral Epicondyle of the Elbow (A.); Ultrasound Image of the ECRL and SU (B. and C.) for Out-of-plane Dry Needling Approaches at 90°; Ultrasound Detection of the Deep Branch of the Radial Nerve Using Doppler as a Reference for Invasive Approaches (D. and E). Abbreviations: BR, Brachioradialis; ECRB, Extensor Carpi Radialis Brevis; ECRL, Extensor Carpi Radialis Brevis; ED, Extensor Digitorum; RH, Radius Head; SU, Supinator.
Pharmacological Treatment Groups: Oral Intake (OralI)/Topical Application (TopA)
The protocol involved using either oral (ibuprofen 400 h) or topical NSAIDs (Diclofenaco KernPharma 11,6 mg/g., skin gel) every 8 h for 30 days, prescribed by the family physician, 21 alongside the eccentric exercise program.
Treatment Protocol
A 30-day treatment plan was followed, where the DN, OralI and TopA groups were evaluated on Day 1 and Day 30. The eccentric exercises and DN intervention were performed individually on Day 1, similar to previous meta-analyses. 22
Statistical Analysis
The statistical analysis of this study was performed using R language (R 4.4.1 software version, Vienna, Austria). Initially, the Kolmogorov-Smirnov test and Cullen and Frey graph were applied to assess the distribution of the data. Descriptive statistics, including means and standard deviations were compiled for normal variables, while medians with interquartile range were shown for non-normal variables. Frequencies and percentages were reported for categorical variables. Baseline homogeneity across the three groups was evaluated using a Chi-square test for categorical variables, and a Kruskal-Wallis test for continuous variables. Effect sizes were estimated using the partial η² coefficient. Post-hoc tests using the Bonferroni correction were applied to identify specific differences between the groups if significant effects were found in the Kruskal-Wallis test. Effect sizes were estimated using the r coefficient.
To assess both intra- differences in pain and functional outcomes measured before and after the 30-day intervention period, a Wilcoxon-Mann-Whitney test for paired samples was utilized. Effect sizes were estimated using the r coefficient.
Finally, the relationship between pain reduction and functional improvement was analyzed using quantile regression models or generalized linear models, depending on the distribution of the dependent variable, in all cases, the
Results
Homogeneity of the groups in demographic variables and outcomes is shown in Table 1. There were no missing values in any of the variables.
Baseline Characteristics and Pre-Treatment Pain Pressure Threshold (PPT) Measurements among the Three Comparis on Groups. for the Categorical variable, the % is Shown, While for the Numerical Variables, the Median with the Interquartile Range (IQR) is Presented. in all Cases, the p-Value is Shown Together with the Effect Size, Obtained After Comparison Between Groups.
*statistically significant p-value
The results of this study revealed significant improvements in PPT in all groups, with varying degrees of efficacy depending on the intervention (Figure 3).

Evolution of Pain Pressure Threshold in the Three Groups.
PPT values for the LatE increased significantly over time (p < 0.001,
Pain reduction in the RS area was also significant (p < 0.001,
Overall pain, as measured by the VAS, decreased significantly across all groups (p < 0.001,
Functional outcomes, assessed through Hand-10 items 1 to 10, showed significant improvement over time. Group-time interactions were also significant, with the DN group outperforming the OralI and TopA groups in functional recovery (Table 2).
Both the Intragroup p_values (Comparison between Groups Pre vs Post Treatments for Each of the Items) and the p_values between the 3 Study Groups are Shown. For Each of the Groups, the Median with the Interquartile Range (IQR) Obtained in Each of the Items of the Hand-10 Scale is Shown.
*statistically significant p-value
Finally, we studied whether there was any relationship between patient age/ gender, and the PPT pre-intervention, without obtaining statistically significant results in any of the cases.
On the other hand, when studying the relationship between VAS and the different PPT prior to the intervention, statistically significant results were found for LatE PPT (
Lastly, dependency relationships were established between each PPT and each of the items that make up the Hand-10 scale. Relationships were found between LatE PPT and item 7
Discussion
This study aimed to assess the effects of combining dry needling and eccentric exercise on LE compared to conventional pharmacological treatment with NSAIDs, oral and topical, combined with eccentric exercise. The study found that while all three treatment groups showed improvements in pain and function over the 30-day intervention period, the combination of DN and eccentric exercise provided the most significant reduction in pain intensity and improvement in hand function. The observed mean improvements in VAS (3.1 cm) exceed established minimal clinically important differences, 23 supporting the clinical relevance of our findings.
The integration of eccentric exercise across all groups is consistent with its proven benefits in managing tendinopathies. 10 In contrast, while NSAIDs are commonly prescribed for LE, 11 their efficacy may be limited when it comes to functional improvement, as shown by our results. This is consistent with the findings from Navarro-Santana et al (2020), which emphasized the effectiveness of dry needling in reducing pain in patients with musculoskeletal-origin LE. 24 Our results also corroborate the findings from Fernández-de-Las-Peñas and Nijs (2019), who explored the neurological and muscular benefits of trigger point dry needling within the context of pain neuroscience. 25
A significant relationship was observed between the VAS scores and PPT measurements at both LatE and RS. As pre-intervention LatE or RS PPT increased, VAS scores also increased, suggesting that higher pressure sensitivity at these points correlates with greater self-reported pain intensity, which is consistent with previous studies. 26
Further analysis revealed significant associations between various PPTs and specific items on the Hand-10 scale. Higher LatE PPT was negatively associated with manual work difficulty, as indicated by item 7. This relationship can be attributed to the involvement of the extensor muscles of the forearm, which attach to the lateral epicondyle. These muscles are critical for wrist extension and finger movement, necessary for performing tasks that involve gripping and lifting, such as manual work. 27 Similarly, ME PPT was significantly linked to difficulties with washing the face, turning a faucet, opening a milk carton, and operating a door. The medial epicondyle is the attachment site for the flexor-pronator muscle group. These muscles are responsible for wrist flexion and forearm pronation. 28 RS PPT was associated with difficulty turning a faucet, as reflected in item 3. The radial styloid serves as an anchor point for muscles that are involved in wrist stability and thumb extension, actions necessary for gripping and turning objects, such as a faucet. 29 US PPT was related to challenges in operating a and performing daily activities.The US is where the ulnar collateral ligament and several muscles, including the extensor carpi ulnaris, insert. This muscle contributes to wrist stability during ulnar deviation, which is necessary for forceful actions like opening a door. 30
Furthermore, VAS pain scores were correlated with lower self-confidence in hand function due to pain, as noted in item 9 (p = 0.029). This broad impact of pain on hand function explains the decreased confidence in performing everyday tasks. 31
These findings emphasize the complex interplay between localized pressure sensitivity and functional impairments in lateral epicondylalgia, showing that targeting specific pain areas with treatments such as dry needling may help improve functional outcomes in daily life.
Limitations
One limitation of the study was the age disparity between the groups, which may have influenced the outcomes. However, despite the statistical significance, the sample still might be considered as young population, with a global mean of 27.4 years (SD = 5.64) and a range of 20 years. Another limitation of this study are the statistically significant differences in functional outcomes for items 1, 3, 4, and 5 of the Hand-10 questionnaires (p < 0.001), with the TopA group consistently showing the highest median scores. This suggests that while all groups improved, the TopA group may have started with greater functional limitations.
Conclusion
In conclusion, this study supports the combined use of dry needling and eccentric exercises as a superior treatment for lateral epicondylalgia, offering greater pain relief and functional improvement than NSAID-based interventions. Eccentric exercise, however, remains a key element of treatment across all interventions.
Footnotes
Authors’ Contributions
ZS and JV were responsible for the conception and design of the study, JV and IM were responsible for recruitment and data collection, HF was responsible for data analysis. ZS, JA and VA were responsible for investigation and draft of the manuscript. All authors contributed to the interpretation of the data for the work and revising it critically for important intellectual content. All the authors finally approved the manuscript.
Consent to Participate Statement
Study participants were asked to sign an informed consent form prior to their participation in the study.
Data Sharing Statement
Data are available upon request from the corresponding author.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethics Approval
Research Ethics Committee of the Nuestra Señora de Sonsoles Hospital, Approval Code: GASAV/2023/44.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Trial Registration
ClinicalTrials.gov, Registration Number: NCT05021354.
