Botulinum toxin type A and acupuncture for masticatory myofascial pain: a randomized clinical trial

DE LA TORRE CANALES et al. · Journal of Applied Oral Science · 2021

🧪Single-Blind RCT👥n=54 patientsHigh Impact

Evidence Level

STRONG
82/ 100
Quality
4/5
Sample
3/5
Replication
4/5
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OBJECTIVE

To compare the effects of botulinum toxin type A and acupuncture in the treatment of masticatory myofascial pain

👥

WHO

54 women with temporomandibular myofascial pain

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DURATION

1 month of treatment with follow-up

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POINTS

LI-4, LI-11, SI-19, LR-2, GB-20, GB-21, GB-34, BL-2, CV-23, TE-23

🔬 Study Design

54participants
randomization

Acupuncture

n=18

4 weekly sessions of traditional acupuncture for 20 min

Botulinum toxin

n=18

Bilateral injection of botulinum toxin (30 U in the masseter, 10 U in the temporalis)

Saline

n=18

Saline solution injection at the same points

⏱️ Duration: 1 month

📊 Results in numbers

p < 0.001

Reduction in self-perceived pain in all groups

p < 0.001

Improvement in pressure pain threshold only with botulinum toxin

p < 0.001

Reduction in EMG activity only with botulinum toxin

p = 0.05

Acupuncture vs botulinum toxin for pain reduction

📊 Outcome Comparison

Reduction in Self-Perceived Pain (VAS)

Acupuncture
85
Botulinum toxin
87
Saline
45

Improvement in Pain Threshold

Acupuncture
20
Botulinum toxin
85
Saline
15
💬 What does this mean for you?

This study compared two approaches for jaw muscle pain: traditional acupuncture and botulinum toxin injections. Both treatments were effective in reducing pain, with no significant difference between them, and were superior to placebo.

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Article summary

Plain-language narrative summary

Masticatory myofascial pain (MMP) is one of the most common causes of persistent facial pain, affecting between 10% and 68% of people with temporomandibular disorder. This randomized controlled trial investigated the comparative efficacy of two promising therapeutic approaches: traditional acupuncture and botulinum toxin type A (BoNT-A) injections for the treatment of this debilitating condition. The research was conducted by Brazilian researchers from respected institutions, including the University of São Paulo and the University of Campinas, following rigorous ethical and methodological standards. The study included 54 women with a confirmed diagnosis of temporomandibular myofascial pain, who were randomly divided into three groups of 18 participants each.

The acupuncture group received four weekly sessions of traditional Chinese acupuncture lasting 20 minutes each, using specific points such as LI-4, LI-11, SI-19, LR-2, GB-20, GB-21, GB-34, BL-2, CV-23, and TE-23. The botulinum toxin group received bilateral injections with 30 units in the masseter muscle and 10 units in the anterior temporalis. The control group received saline injections at the same locations. Evaluation included measures of self-perceived pain through the visual analog scale, pressure pain threshold by digital algometry, and electromyographic activity of the masticatory muscles.

All measurements were performed before treatment and one month after the start of therapy. The results revealed that all three groups showed significant reduction in self-perceived pain after one month (p < 0.001). Interestingly, there was no statistically significant difference between acupuncture and botulinum toxin in pain reduction (p = 0.05), but both approaches were superior to the control group (p < 0.05). However, only the group that received botulinum toxin showed significant improvement in pressure pain threshold, indicating a reduction in pain sensitivity.

An important finding was that botulinum toxin caused a severe reduction in electromyographic activity of the treated muscles, which should be considered an adverse effect, as it may result in temporary muscle weakness. This effect was not observed with acupuncture, suggesting an advantage of this approach in terms of safety. The mechanisms of action differ between the treatments: botulinum toxin acts by blocking the release of acetylcholine at the neuromuscular junction and inhibiting pain neurotransmitters, while acupuncture modulates pain through peripheral and central inhibition mechanisms. The clinical implications are significant.

The study suggests that both acupuncture and botulinum toxin can be valid options for patients with masticatory myofascial pain refractory to conservative treatments. Acupuncture may be preferable as a first-line treatment due to the lower risk of adverse effects, while botulinum toxin may be reserved for more severe or refractory cases. The similar efficacy between treatments offers clinicians and patients therapeutic options based on individual preferences, specific contraindications, and resource availability. The study presents important limitations, including only one month of follow-up, exclusive inclusion of women, and the lack of evaluation of psychosocial factors that may influence pain chronification.

Future studies with longer follow-up time and more diverse populations will be necessary to confirm these findings.

Strengths

  • 1Randomized controlled design with placebo group
  • 2Objective evaluation with electromyography and algometry
  • 3Well-structured methodology and adequate blinding
  • 4First direct comparison between acupuncture and botulinum toxin for this condition
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Limitations

  • 1Follow-up of only 1 month
  • 2Exclusively female sample
  • 3No evaluation of psychosocial factors
  • 4Relatively small sample size
Dr. Marcus Yu Bin Pai

Expert Commentary

Dr. Marcus Yu Bin Pai

MD, PhD · Pain Medicine · Physical Medicine and Rehabilitation · Medical Acupuncture

Clinical Relevance

Masticatory myofascial pain is a condition that frequently arrives at the pain and rehabilitation service after the patient has been to multiple specialists, often with conservative treatments already exhausted. This clinical trial places into comparative perspective two therapeutic resources that we use routinely, offering the physiatrist and the pain specialist a basis for second-line discussion with the patient. The central finding — analgesic equivalence between acupuncture and botulinum toxin type A at the end of one month — is clinically operational: it allows structuring a conversation about risks, costs, and patient preferences without sacrificing efficacy. Acupuncture emerges as a valid alternative for women with myofascial temporomandibular dysfunction who present contraindications to injections, aversion to invasive procedures, or restricted access to BoNT-A, integrating well with the multidisciplinary protocol that includes occlusal splint, cervical postural control, and bruxism management.

Notable Findings

The finding that most deserves clinical attention is not the pain reduction itself — expected in both active groups — but the dissociation between subjective analgesia and objective outcomes. Botulinum toxin was the only intervention to significantly raise the pressure pain threshold by algometry (p < 0.001), suggesting modulation of peripheral sensitization that acupuncture, in this protocol, did not reproduce. On the other hand, the severe reduction in electromyographic activity in the BoNT-A group raises a relevant functional question: are we treating pain at the cost of temporary masticatory hypotrophy, which in patients with high-intensity bruxism or functional malocclusion may have non-trivial biomechanical consequences. The fact that the saline group also presented significant reduction in self-perceived pain reinforces the weight of the non-specific effect in this condition and should calibrate expectations when communicating prognosis.

From My Experience

In my practice, masticatory myofascial pain rarely presents in isolation — there is almost always an associated cervical component, and treating only the masticatory musculature without addressing the upper trapezius and suboccipitals tends to generate early relapses. I usually see perceptible analgesic response between the second and third acupuncture session when I combine local points with distal points of descending modulation, and the complete protocol up to maintenance turns around eight to ten sessions in my service. What this study confirms is something I observe clinically: four sessions are already enough to move the needle in terms of self-perceived pain, which is useful for engaging skeptical patients. I reserve botulinum toxin for cases with documented masseter hypertrophy, severe bruxism with previous failure of acupuncture, or when there is analgesic urgency. The combination that works best in my experience is acupuncture combined with orofacial physical therapy and cervical postural work — I rarely indicate acupuncture alone for this patient profile.

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture.

Full original article

Read the full scientific study

Journal of Applied Oral Science · 2021

DOI: 10.1590/1678-7757-2020-1035

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Scientific Review

Marcus Yu Bin Pai, MD, PhD

Marcus Yu Bin Pai, MD, PhD

CRM-SP: 158074 | RQE: 65523 · 65524 · 655241

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.

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Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.

Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.