Dry Needling Combined With Guideline-Based Physical Therapy Provides No Added Benefit in the Management of Chronic Neck Pain: A Randomized Controlled Trial

Stieven FF, Ferreira GE, Wiebusch M, De Araújo FX, Da Rosa LHT, Silva MF. Dry needling combined with Guideline-Based physical therapy provides no added benefit in the management of chronic neck pain: a randomized controlled trial. Journal of Orthopaedic & Sports Physical Therapy. 2020;50(8):447-454. doi:10.2519/jospt.2020.9389

Link to Original Article: https://www.jospt.org/doi/10.2519/jospt.2020.9389

Key Points

1. The study aimed to determine the added benefit of combining dry needling with a guideline-based physical therapy treatment program for chronic neck pain.

2. Participants were randomly assigned to receive either guideline-based physical therapy or guideline-based physical therapy plus dry needling, with primary outcomes measured at 1 month post randomization.

3. Results showed that combining dry needling with guideline-based physical therapy resulted in a small reduction in average pain intensity at 1 month post randomization, but no effect on disability.

4. There were no significant differences between the groups for secondary outcomes such as global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy at 1, 3, and 6 months post randomization.

5. Adverse events were reported in both groups, with temporary exacerbations of neck pain and/or headache symptoms being the most common.

6. The study concluded that adding dry needling to guideline-based physical therapy provided a small improvement in pain only in the short term, with no significant impact on disability, global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy.

Introduction

The research paper explores the high prevalence and significant burden of neck pain, emphasizing its multifactorial etiology and various predisposing risk factors. Specifically, it discusses the conflicting recommendations regarding the use of dry needling for neck pain, with Canadian and Dutch guidelines discouraging its use, while American guidelines endorse it based on moderate evidence. The current treatment guidelines for chronic neck pain include manual therapy of thoracic and cervical manipulation or mobilization along with strength, endurance, coordination, proprioception, and postural exercise therapy. Prior studies indicate dry needling is superior to sham needling for pain relief up to 12 weeks, but trial designs include assessing short-term effects, high risk of bias, and lack of strong comparators to reflect current clinical practice. The paper emphasizes the need for pragmatic trials to better understand the effects of dry needling on neck pain.

Methods

The study was conducted in Porto Alegre, Brazil by conducting a 2-arm randomized controlled trial with concealed allocation and blind outcome assessment. The trial was approved by the Federal University of Health Sciences, Porto Alegre Ethics Committee.

Participants, Therapists, and Settings

The study recruited participants from the community through local newspapers and social media advertisements from October 2016 to March 2018. Inclusion criteria comprised individuals aged 18 to 65 years with non-specific neck pain persisting for at least 3 months, with specific pain and disability levels. Participants reported >3 out of 10 on Numeric Pain Rating Scale (NPRS) and >15 out of 100 on Neck Disability Index (NDI). Exclusion criteria included those with certain medical conditions including nerve root compression, pregnancy, diagnosis of tendinopathy, fibromyalgia, medication usage such as antidepressant and anti-coagulant, and fear of needles. Three physical therapists with 6.8 ± 2.8 years of experience provided treatments at 3 private physical therapy practices in Porto Alegre, Brazil. All therapists had postgraduate qualifications in rehabilitation sciences, focusing on musculoskeletal conditions, and underwent standardized training procedures prior to the study.

Randomization

The randomization process in the study was carried out by a researcher who was not involved in any other aspect of the research. This individual prepared sealed and sequentially numbered envelopes in blocks of 6 and 8, each containing the group allocation. Randomization was stratified based on the participants' baseline pain intensity, which was categorized as low (3-6 points) or high (7-10 points). The allocation of participants was done at a 1:1 ratio. To maintain the integrity of the process, the researchers responsible for outcome assessment and treatment were not provided access to the envelopes. The participants were randomized to either a guideline-based physical therapy program or a guideline-based physical therapy program accompanied by dry needling. Importantly, baseline characteristics were collected before the randomization process occurred.

Assessment Instrument

The participants in the study used Google Forms to complete the outcome assessment online. A research who is blinded to the study managed all online forms. The physical therapists and participants were not blinded due to the nature of the study.

Intervention

The intervention in the study was conducted by one of three physical therapists and consisted of 40-minute treatment sessions over four weeks, with 4 to 6 total number of sessions. Participants received a rehabilitation protocol including exercise and manual therapy, with the specific treatments (neck and thoracic mobilization, strengthening neck and upper back muscles against manual resistance) decided by the therapist based on clinical reasoning. The primary goals of the intervention were to reduce neck pain, strengthen muscles, improve range of motion, and educate participants about neck self-care. In addition, participants in the physical therapy plus dry needling group received dry needling on posterior neck muscles at the end of each session, with the therapist determining which muscles to treat based on the presence of hyperirritable and hyperalgesic nodules at the discretion of the treating physical therapist. The needles used were sterile stainless steel acupuncture needles (0.25 × 40 mm), and were introduced subcutaneously, penetrating the skin at 10 to 15 mm of depth, and manipulated to elicit a local contraction response. Multiple twitch responses were elicited by performing vertical pistoning without rotational needle movement

Outcomes

The primary outcomes of the study were average pain intensity and disability measured at 1 month post randomization. Pain intensity was assessed using the Numerical Pain Rating Scale (NPRS) with a higher score indicating worse pain. A between-group difference of at least 2 points on the NPRS was considered clinically important. Disability was measured with the Neck Disability Index (NDI) with a higher score indicating more disability, and a between-group difference of 7.5 points was deemed clinically important.

The secondary outcomes included pain and disability measurements at 3 and 6 months post randomization, global perceived effect of treatment using the Global Perceived Effect (GPE) scale, quality of sleep assessed with the Pittsburgh Sleep Quality Index (PSQI), pain catastrophizing measured with the Pain Catastrophizing Scale (PCS), and self-efficacy measured with the Pain Self-Efficacy Questionnaire (PSEQ). The GPE scale ranges from -5 to +5, with higher scores indicating better perceived recovery. The PSQI measures sleep quality on a scale of 0-21, where higher scores indicate poorer sleep quality. The PCS measures pain catastrophizing on a scale of 0-52, with higher scores indicating higher pain-related catastrophizing. The PSEQ assesses pain self-efficacy on a scale of 0-60, with higher scores indicating higher pain self-efficacy. Scores lower than 15 points indicate substantially reduced self-efficacy. These outcomes were collected at 1, 3, and 6 months post randomization.

Adverse Events

In this study, participants were closely monitored for any adverse events following the intervention. Adverse events were defined as any symptoms reported by the participants that were distressing and deemed unacceptable, necessitating further treatment. The severity of adverse events was categorized into three levels: serious, significant, and mild. Serious adverse events were those requiring hospital admission and could potentially lead to persistent or significant disability or even death. Significant adverse events required medical attention and interfered with the participants' daily activities. Mild adverse events were characterized by their short duration, reversibility, and minimal inconvenience to the participants.

Statistical Analysis

The researchers in this study used WinPepi software to determine the required sample size for their study, aiming for a sample of 116 participants to achieve 90% power and detect a mean difference of 2 points on a 0-to-10 Numerical Pain Rating Scale (NPRS), while accounting for a 20% potential loss to follow-up. Data were double-entered and analyzed by a blinded statistician. They employed intention-to-treat analysis, meaning participants were analyzed according to their initial group allocation. Data normality was confirmed using histograms. Continuous variables were presented as mean ± standard deviation, while categorical data were expressed as frequencies and proportions.

To assess the effects of treatment on various outcomes, including pain, disability, global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy, the researchers used a repeated-measures linear mixed model with terms for participant, group, time, and group-by-time interaction. They utilized multiple imputation for any missing data. Statistical analyses were conducted using SPSS Version 23.0, with statistical significance set at P<.05.

Results

The study, which took place between October 2016 and March 2018, included 116 participants out of 279 who self-referred. The retention rates were consistently high, with over 90% of participants at all time points. Most participants were women, and they reported moderate levels of neck pain and disability. Both the physical therapy and physical therapy plus dry needling groups had similar baseline characteristics. Participants received an average of 4.8 treatment sessions. During the follow-up period, a small number of participants were lost to follow-up. In the physical therapy group, 4 participants were lost (2 moved to another city and 2 could not be contacted), while in the physical therapy plus dry needling group, 5 were lost due to loss of contact. Participants who received fewer than 6 sessions did so due to missed appointments.

Effect on Primary Outcomes

The Effect on Primary Outcomes of the research paper indicate there was a significant group-by-time interaction for average pain at 1 month. The participants in physical therapy plus dry needling group had a small decrease in average pain intensity in the previous 24 hours and in the previous week compared to physical therapy group alone with the mean difference of 1.56 between the groups. However, there was not a significant change for disability at 1 month.

Effect on Secondary Outcomes

The Effect on Secondary Outcomes section of the research paper indicates that there were no significant differences between the groups in terms of average pain intensity in the previous 24 hours at 3 months and 6 months, as well as in the previous week at 3 months and 6 months. The mean differences and confidence intervals support the lack of statistically significant differences between the groups for these measures. Additionally, there were no significant between-group differences for disability at 3 months and 6 months. The mean differences and confidence intervals again suggest the absence of statistically significant differences in disability between the groups at these time points. Furthermore, the study found no group-by-time interactions for global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy, as indicated by the non-statistically significant P-values for these measures.

Adverse Events

Mild adverse events were reported in 6 out of 58 participants in the physical therapy group and 8 out of 58 participants in the physical therapy plus dry needling group. No participants withdrew from the session due to adverse events.

Discussion

The research paper investigated the effectiveness of adding dry needling to guideline-based physical therapy for chronic neck pain. The study found that adding dry needling resulted in a small reduction in average neck pain intensity at 1 month post randomization, but not at 3 and 6 months, with no added benefit for disability, global perceived effect, sleep quality, pain catastrophizing, and self-efficacy. The short-term pain reduction did not translate to improvements in disability, and the authors caution against considering dry needling as an approach to managing chronic neck pain.

The study supports previous research on the short-term effects of dry needling on pain, reporting more reliable effect estimates. However, the short-term improvements in pain were not accompanied by improvements in disability. The study also found that the proportion of adverse events reported in the sample was lower than previous research, suggesting that patients who received dry needling were not at a greater risk of harm. The study had high retention rates and was adequately powered, but blinding was not possible due to the nature of the intervention. Overall, the study provides valuable insights into the effects of adding dry needling to guideline-based physical therapy for chronic neck pain and highlights the need for ongoing monitoring of safety in physical therapy treatments.

Conclusion

The research paper examined the impact of adding dry needling to guideline-based physical therapy for chronic neck pain. The findings revealed that while the addition of dry needling led to small improvements in pain in the short term (1 month), these improvements were not clinically meaningful and did not persist in the long term (6 months). Moreover, dry needling did not improve disability, global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy at any time point. The study highlighted that the combination of guideline-based physical therapy and dry needling had no significant effect on disability in individuals with chronic neck pain.

The implications of the findings suggest that due to the minimal and clinically unimportant reduction in pain, particularly in the short term, clinicians should not consider adding dry needling to physical therapy as a treatment for chronic neck pain. The study also noted that only three therapists delivered interventions in both groups, which may limit the generalizability of the results. Additionally, the improvements observed in both groups could be attributed to the natural course of neck pain. Therefore, caution is warranted in interpreting the results, and the potential impact of individual therapist variation and the natural progression of neck pain should be considered.

Opportunities for Future Research

1. Long-term effects of dry needling: Investigate the long-term effects of dry needling in combination with guideline-based physical therapy for chronic neck pain, considering outcomes such as pain intensity, disability, global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy at intervals beyond 6 months post randomization. This would contribute to understanding the sustainability and efficacy of the treatment over an extended period.

2. Subgroup analysis: Undertake subgroup analyses to investigate whether specific demographics, such as age, gender, or duration of neck pain, influence the effectiveness of dry needling in conjunction with physical therapy. Identifying subgroups that may benefit more from this combined treatment approach could offer valuable insights for personalized treatment strategies.

3. Comparative effectiveness: Conduct a comparative effectiveness study to evaluate the efficacy and safety of dry needling combined with guideline-based physical therapy in comparison to other interventions commonly used for chronic neck pain, such as spinal manipulative therapy or pharmacological treatments. This could provide evidence for the relative benefit of dry needling within the spectrum of available treatment options.

4. Adverse events and safety: Further investigate the occurrence and nature of adverse events related to dry needling in the context of chronic neck pain management. This could involve larger sample sizes to capture rare adverse events and provide comprehensive safety data to inform clinical practice.

5. Mechanisms of action: Explore the underlying mechanisms of action of dry needling in the management of chronic neck pain, including its effects on neurophysiological pathways, pain modulation, and musculoskeletal function. Investigating the physiological and psychological responses to dry needling can enhance our understanding of how it may impact pain and disability outcomes.

6. Implementation and clinical practice: Investigate the practical implementation of incorporating dry needling into guideline-based physical therapy for chronic neck pain within clinical settings. This may involve studying the training, competency, and experience of therapists, as well as patient preferences and adherence to treatment, to optimize the delivery and integration of this combined approach in real-world practice.