ABSTRACT
Introduction
Medial tibial stress syndrome (MTSS) is also called soleus syndrome because the resultant periostitis is localized to the medial insertion of the soleus muscle. This study explores the effectiveness of dry needling (DN) targeting soleus myofascial trigger points (MTrPs) in managing MTSS.
Aim
To assess the impact of DN on pain reduction and ankle range of motion (ROM) improvement in athletes with MTSS.
Study Design
This randomized controlled trial (RCT) included 50 university-level athletes. (DN group = 25; control group = 25)
Method
Outcome variables, pain, and ankle dorsiflexion ROM were measured using the Numeric Pain Rating Scale (NPRS) and universal goniometer, respectively. The trial used statistical analyses like Wilcoxon rank test for within-group comparisons and Mann-Whitney U test for between-group comparisons. The trial was registered with the Clinical Trials Registry of India; CTRI/2023/10/058837.
Result
There were 24 Females (Age = 21.4 ± 2.06) & 26 Males (Age = 20.5 ± 2.35). DN significantly reduced pain in the intervention group from NPRS 7 ± 1.30 to 2 ± 0.87 (p < 0.001), but in the control group, the pain increased from NPRS 7 ± 0.99 to 7 ± 1.05 (p = 0.009). There was no improvement in ankle ROM.
Conclusion
DN effectively alleviated MTSS-associated pain in the short-term but was not effective in improving ankle ROM.
KEYWORDS: Shin pain, soleus, trigger points, therapy, dry needling
Introduction
Medial tibial stress syndrome (MTSS) is one of the most commonly observed overused leg injuries [1], with incidence rates ranging from 4% to 19% in athletic populations. MTSS is characterized by the pain that is caused by exercise along the posteromedial tibial border. This pain is palpable over a distance of at least five centimeters [2].
The primary etiology of MTSS is believed to be underlying periostitis of the tibia. However, new research suggests that MTSS is probably caused by a variety of tibial stress injuries, such as tendinopathy, periostitis, periosteal remodeling, and tibial stress reactions. It is also frequently associated with dysfunction of the soleus, tibialis anterior, and tibialis posterior muscles. Since chronic, recurrent loads result in abnormal strain and bending of the tibia, it appears that changes in tibial loading are the source of these various tibial stress injuries [3]. Training in a fatigued state may contribute to the high-stress fracture [4]. In the beginning, the pain is felt as soon as activity begins and goes away with prolonged exercise, but later on, it may persist through activity [1]. A strong aponeurotic layer called the soleus bridge attaches to the tibial periosteum. A periostitis could result from traction at this location [5]. According to James [6], when the soleus muscle contracts or stretches, this aponeurosis may transfer traction stress to its attachment on the medial edge of the tibia. This would support the theory that the precipitation of MTSS is influenced by ballistic action and/or hard surfaces. The soleus muscle resists these stresses by contracting eccentrically [6].
Considering the etiology, therapy, and therapeutic modalities that have focused on the symptomatic pain component of this condition, there have been many different treatment approaches used, with differing degrees of success. These include biomechanical therapies such as orthotics, non-steroidal anti-inflammatory drugs, and modalities such as ultrasound [7]. However, the periosteal component of the condition has not received much attention from these therapies.
Therefore, the purpose of this study was to determine whether DN (Dry needling) was a useful treatment for MTSS. DN is defined as the penetration of a solid needle through the skin without the introduction of any drug to stimulate TrPs (trigger points) and connective tissue for the management of neuromusculoskeletal pain. It is low-risk and minimally invasive. DN is an effective method of treatment for alleviating symptoms caused by TrPs. Clinical studies have shown that insertion of a needle into the point of maximum pain and eliciting a local twitch response result in the largest therapeutic effects, such as restoration of ROM, less use of pain medication, improved quality of life (QoL), and pain relief [8]. There is a lack of literature exploring DN’s effectiveness on pain and ROM (range of motion) of ankle dorsiflexion in athletes with MTSS. Therefore, this clinical trial aimed to determine the short-term effects of DN with stretching on pain and ROM in athletes with MTSS. We hypothesized that athletes who received DN together with stretching would benefit more than those who received no treatment.
Method
Sample size
A sample size of 50 was calculated by G*Power version 3.1.9.4, with an effect size of 0.5, a statistical power of 95%, and an alpha error of 0.05.
Study design
The trial, an RCT, was structured as a parallel-group study and implemented double-blinding. In this study, the participants and statistical analyst were blinded. Participants were unaware of the treatment group they belonged to and details of the intervention before treatment provision and the statistician was unaware of the assigned intervention. Randomization was carried out using a computer-generated method to generate the sequence. The on-site computer system was used for the Method of Concealment.
The study ran for five months. Athletes were assessed for MTSS based on clinical examination and history [2]. The pain and ROM were measured at baseline and after the last session of the one-week protocol. A sample size of 50 participants was considered sufficient for the feasibility of the study. The protocol followed in this study adheres to the SPIRIT 2013 Statement, which defines standard protocol items for clinical trials and is informed by the TIDieR (Template for Intervention Description and Replication) and CONSORT 2010 Statement extensions for randomized pilot and feasibility trials. The study was approved by the Institutional Ethics Committee (Number 1416/HG, dated 27 March 2023) of Guru Nanak Dev University, Amritsar, Punjab. The study was performed according to the National Ethical Guidelines for Biomedical and Health Research, involving human participants’ guidelines given by the Indian Council of Medical Research and the Declaration of Helsinki. This trial was registered with the Clinical Trials Registry-India: CTRI/2023/10/058837.
Study setting
The study setting was the MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar, Punjab, India.
Participants
Total participants (n = 50), both male (n = 26) and female (n = 24), were recruited and allocated to the DN group (n = 25) and control group (n = 25) from October 2023 to February 2024. The athletes included in the study were 18–25 years old; the level was university level; and the diagnosis of MTSS was made based on a positive physical examination and history [2]. Athletes reporting pain for more than 3 months (chronic pain) were included in the study [9] If an eligible participant presented with bilateral shin pain, only the self-nominated ‘worst’ shin was included. Medial Tibial stress syndrome was differentiated from a stress fracture of the tibia with the help of a tuning fork and therapeutic ultrasound [10]. The athletes were excluded if they feared needles or had a one-year prior injury related to a stress fracture of the tibia or posterior compartment syndrome, meniscal tears, ligamentous sprains, osteoarthritis, or muscular strain.
They were informed of the testing procedures and given written consent forms. They entered the study after signing an informed consent form. They were informed that participation in the study was entirely voluntary and that they might discontinue at any moment. All of the athletes were also given explanations of the risks and potential advantages. The intervention was administered individually within the study setting.
Outcome variables
Pain and ankle ROM was measured with NPRS and a universal goniometer by the physical therapist. These variables were assessed at baseline and after the one-week protocol.
>NPRS is aset of numbers with verbal anchors that indicate the whole range of pain intensity that can occur. Patients were asked to rate their pain from 0 to 10. 0 represent ‘no pain’, while 10 represent ‘the most intense pain imaginable’, ‘pain as intense as it could be’, ‘and maximum pain’ [11].
The ankle range of motion was measured by a physical therapist with the help of a universal goniometer [12]. Ankle dorsiflexion ROM was measured sitting with the knee flexed to 90 degrees. The stable arm was kept at the midline of the fibula using the head of the fibula as a guide, the fulcrum was placed over the lateral malleolus and the movable arm was placed parallel to the lateral aspect of the 5th metatarsal.
The reliability of a physical therapist in measuring range of motion (ROM) with a universal goniometer can be influenced by various factors, including the motions measured, methods of application, and variations among different patient types. In our research, we enhanced intratester reliability by using a standardized testing protocol. This involved a single physical therapist measuring ankle ROM with a universal goniometer, consistently referencing the same anatomical landmarks [13].
Intervention
The DN was done for soleus muscle by a physical therapist for 3 alternate days. This technique consisted of the insertion of a disposable 0.25 × 40 mm stainless steel needle that was inserted through the skin over the MTrP. Two 0.25 × 40 mm stainless steel needles were used. The position of the athlete was prone lying (Figure 1) or Faber’s (affected leg in the figure of four on the unaffected leg) (Figure 2) position.
Figure 1.
Prone lying.
Figure 2.
Faber’s lying.
After locating an MTrP by moderate manual flat palpation, the overlying skin was cleaned with 70% isopropyl alcohol. The needle was subsequently inserted, penetrating the skin and muscle to a depth of approximately 40 mm into the MTrP of the muscle by holding the soleus muscle in a pincer grip and pulling it away from the midline to avoid a neuro-vascular bundle. The depth of the insertion was 40 mm as the whole needle was inserted in the soleus. Once inserted into the MTrP, the needle was moved until the first local twitch response was obtained. It is suggested that multiple local twitch responses should be elicited during DN for successful treatment. Once the first local twitch response was obtained, the needles were left in place for another 15 minutes [14].
The soleus and surrounding muscles were stretched for 30 s after the procedure. Active soleus stretching was performed in the standing position. Since DN sometimes induces post-treatment soreness, athletes were advised to report any increase in their symptoms after the intervention. Stretching of the soleus muscle was also suggested as a home exercise program for the next day of the intervention. Three sessions of DN were performed in a week, and then the patients were reevaluated after the last session. During the treatment, athletes in both the control and intervention groups were suggested to continue their normal activity which included jogging, running, and jumping. They didn’t refrain from doing any daily routine exercise. Soleus stretching was the only exercise suggested for the intervention group other than their normal activity. No specialized exercise program was suggested for the control group other than their normal activity or routine exercise.
The intervention adherence or fidelity was assessed by the supervisor of the study.
Safety
Safety worries primarily revolve around complications following DN (bruising, bleeding, soreness, and pain).
According to a recent study by Brady et al. [15], bruising, bleeding, and discomfort occur at a rate of 20% as the most frequent side effects associated with routine DN administration. These episodes were categorized as light because they were transient and did not necessitate more medical attention, moderate to severe adverse effects necessitating additional medical attention or causing great distress (e.g. fainting, headache, nausea) [15].
Participants were asked to notify the research administrator of any adverse events, which were forwarded to the physician of the Health Centre of Guru Nanak Dev University, Amritsar. The physician provided further treatment for the patients.
Although there are many adverse effects related to dry needling, but in our research, we did not find any. Therefore, there was no need to refer them to a physician for further treatment.
Statistical analysis
Statistical analysis was performed using the Jamovi project (2022). jamovi. (Version 2.3)
The level of statistical significance was set at p < 0.05.
Within and between groups, results were analyzed statistically using a Wilcoxon rank and Mann-Whitney U tests for non-parametric variables, respectively.
Results
Sixty-two athletes were recruited, but eight of them didn’t meet the inclusion criteria, and four of them declined participation, so 12 athletes were excluded. The remaining 50 athletes were considered for data collection; from the beginning of the study, age, degree of activity, and prior medical history were noted. Demographic data for each group are provided in Table 1.
Table 1.
The mean and standard deviation values of demographic data of group a and group B.
| Group number | Mean | Standard deviation |
|
|---|---|---|---|
| Age | Dry needling | 20.06 | 1.51 |
| 19.9 | 2.08 | ||
| Control | 21.9 | 2.23 | |
| 21.4 | 2.59 | ||
| Height_in_cm | Dry needling | 163.2 | 4.99 |
| 169.0 | 8.52 | ||
| Control | 161.5 | 4.93 | |
| 173.4 | 6.60 | ||
| Weight_in_kg | Dry needling | 54.1 | 5.51 |
| 57.9 | 8.81 | ||
| Control | 53.7 | 3.13 | |
| 65.6 | 9.55 | ||
| BMI_in_kg/m2 | Dry needling | 20.3 | 1.96 |
| 20.2 | 1.61 | ||
| Control | 20.6 | 1.82 | |
| 21.8 | 2.51 |
Abbreviations: cm (centimeters); kg (kilograms); BMI (body mass index); kg/m2 (kilograms/meter2).
Table 1 shows the anthropometric characteristics of athletes, which include age (in years), height (Cm), weight (kg), and body mass index (kg/m2).
The Consolidated Standards of Reporting Trials (CONSORT) flowchart (Figure 3) depicts a summary of information about the enrollment of athletes, their treatment allocation, and how they were analyzed in the trial.
Figure 3.
The consort flow diagram of the current study.
Data normality was assessed using the Shapiro-Wilk test. The normality was assessed for both demographic data and outcome measures data. The data were not normally distributed, so non-parametric tests were used.
Within-group comparison
Regarding within-group comparison, Wilcoxon rank test was used. For the DN group, the median NPRS scores decreased significantly with a p-value <0.001. However, the ROM median scores showed a non-significant change with a p-value of 0.138 (Table 2).
Table 2.
Pre-NPRS and post-NPRS as well as pre-ROM and post-ROM values of the DN and control group.
| Groups | Variables | Median ± SD |
p-value | |
|---|---|---|---|---|
| Pre | Post | |||
| DN Group | NPRS | 7 ± 1.30 | 2 ± 0.87 | p < 0.001 |
| ROM of ankle dorsiflexion |
19 ± 2.17 | 20 ± 2.30 | p = 0.138 | |
| Control Group | NPRS | 7 ± 0.99 | 7 ± 1.05 | p = 0.009 |
| ROM of ankle dorsiflexion |
18 ± 2.83 | 19 ± 2.58 | p = 0.708 | |
Abbreviations: SD-standard deviation; NPRS-Numeric Pain Rating Scale; ROM- Range of motion.
In contrast, the control group showed a significant increase in median NPRS scores with a p-value of 0.009. The ROM median scores for the control group did not show a significant change with a p-value of 0.708.
Between-group comparison
Regarding group comparison, Mann-Whitney U test was used. Analyzing and comparing the data after one week revealed significant differences between both groups regarding pain. According to the results presented in Table 3, after comparing the two groups, the intervention group’s post-NPRS values were lower than those of the control group (p = <0.001). When we compared the two groups for post-ROM, there was no significant difference (p = 0.277).
Table 3.
Post-NPRS and post-ROM values of DN and control group.
| Variables | Groups | Median ± SD | Median Difference | p-value |
|---|---|---|---|---|
| NPRS | DN Group | 2 ± 0.87 | −5 | < 0.001 |
| Control Group | 7 ± 1.05 | |||
| ROM of ankle dorsiflexion |
DN Group | 20 ± 2.30 | 1 | 0.277 |
| Control Group | 19 ± 2.58 |
Abbreviations: SD-standard deviation; NPRS-Numeric Pain Rating Scale; ROM- Range of motion.
Discussion
The purpose of this study was to evaluate the short-term effectiveness of DN on pain and ROM in MTSS. This study provides sufficient evidence that DN and stretching are more helpful in reducing pain in comparison to no intervention, but no effect was found of DN on ROM of ankle dorsiflexion.
These results showed that DN is effective in treating musculoskeletal disorders such as trigger points and myofascial pain syndrome in the short-term. The study done by Jain et al. [16] also found that DN with conventional treatments (ultrasound, strengthening exercises, and stretching in addition to cryotherapy) appears to be more effective than conventional treatment for relieving pain alone. Another systematic review by Morihisa et al. [8] suggested that DN is an effective intervention for reducing pain associated with lower quarter TRPs in the short term.
According to Dunning et al. [17], the pain reduction is due to increased microcirculation, increased opioid levels, and reduced plasma cortisol levels at the location of needle insertion, but Staud and Price [18] suggested DN’s effects on the limbic system and central descending inhibitory pathways also help to reduce pain and sensitivity, which in turn increases functional activity [18,19]. On the other hand, reduced levels of substance P and oxytocin-related peptides, stimulation of alpha-neurons, and activation of the noradrenergic inhibitory pain system are some of the suggested mechanisms for pain reduction [20–22]
In our study, we did not find any significant difference between DN and the control group’s ROM. Still, contrary to our results, the study done by Alaei et al. [23] suggested that DN improves hamstring flexibility more effectively than static stretching [23].
Limitations
This RCT provides a potential foundation for future research and clinical application of DN due to the results of the studies. Further studies investigating the effect of DN in comparison to and in conjunction with other interventions such as exercise therapy would be beneficial to optimize outcomes in clinical settings. Furthermore, long-term follow-up measurements should be obtained to determine whether DN can produce lasting and positive effects on pain in MTSS. Follow-up measurements for ROM of ankle dorsiflexion are advised to be taken a few days after the application of DN to reduce the effect of inflammation on ROM and the effect of DN on functional outcomes, and the MTSS score should be measured. Healthcare professionals, such as physical therapists, can consider incorporating DN into their treatment plans for athletes with MTSS. However, it is important to note that DN should only be performed by trained professionals who have a thorough understanding of the technique and its potential risks and benefits.
Conclusion
The results of this study suggest that DN is an effective intervention for reducing pain in the short-term, but DN does not have any positive effects on ROM of ankle dorsiflexion. However, further research is required to validate this assertion.
Supplementary Material
Acknowledgements
I would like to express my heartfelt thanks to the MYAS-GNDU Department of Sports Sciences and Medicine for providing funding for conducting this study. The authors would like to thank all the players, team physiotherapists, and coaches who contributed to the data collection.
Biographies
Dr. Amrinder Singh, has good research experience in the field of Sport Rehabilitation, sports Biomechanics and Physical activity and Lifestyle Disorders. He has made significant contributions to both academia and professional sports. He has immense experience in research with 61 publications, 37 research papers and Book chapters in International and national journals. He has been a resource person at various national and international congresses and conferences, sharing his expertise on platforms such as the Asian Federation of Sports Medicine Congress and the World Congress on Sciences & Medicine in Cricket and many more. He has guided 44 master’s theses till now, supervised Ph.D. candidates, and played a pivotal role in organizing workshops and placement drives.
Nikita Wadhwani, Physiotherapist with a Master’s in Sports Physiotherapy, experienced in working with athletes across various sports, focusing on ability assessment, rehabilitation, and performance training. Skilled in injury prevention and management for all ages and skill levels, and actively engaged in sports science research.
Monika Sharma, Research fellow with extensive experience and achievements, highly skilled and dedicated Physiotherapist with a strong background in sports medicine and performance analysis.
Funding Statement
This research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Author contributions statement
All authors contributed fully to the fulfillment of this research article
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/10669817.2024.2384611.
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