Table 1.
The extracted study characteristics of the eighteen included systematic reviews
| Author, year Country Type of review |
Objectives of included review | Intervention (I) Control (C) |
Participant details | Number of databases sourced and searched and date range of database searching | Publication date range of studies included in the review that inform each outcome of interest | Number of studies, types of studies and country of origin of studies included in each review | Instrument used to appraise the primary studies and the rating of their quality | Outcomes reported that are relevant to the umbrella review question | Method of synthesis/analysis employed to synthesize the evidence | Comments or notes the umbrella review authors may have regarding any included study |
|---|---|---|---|---|---|---|---|---|---|---|
|
Ahmed, 2019 Canada (Ireland) MA |
To compare the effectiveness of local anesthetics and BoNT-A on pain intensity in patients with myofascial pain |
I: BoNT-A C: control or alternate intervention (e.g. needling, acupuncture, massage) |
Disorder: Myofascial pain (whiplash associated disorder, mechanical neck disorder, myofascial pain syndrome) N: 1458 60.2% F Age range: adults Mean age range: 30.4–77.6 y |
3 From the inception of the database until May 2017 |
2008-2012 |
33 studies RCT, CT, RT 2 studies - TMD 1 BoNT-A vs saline 1 BoNT-A vs other treatment (fascial manipulation) |
Primary studies: Data extraction table Quality: Cochrane Handbook of Systematic Reviews |
1. Visual analogue scale (VAS) 2. Neck Pain and Disability Scale |
SMD (95% CI) for effect sizes A random-effects model (DerSimonian and Laird method) was used when pooling findings due to heterogeneity The Cohen criteria were used to determine the effect size of the computed SMD values. Publication bias was assessed using the Egger test |
|
|
Al-Moraissi, 2020 Yemen (Egypt, USA, Sweden) NMA |
To evaluate the present knowledge base regarding dry or wet needling as a treatment in patients with TMD myalgia. |
I: dry needling, acupuncture, wet needling (LA, BoNT-A, Granisetron, PRP), passive placebo C: real active placebo |
Disorder: TMD myofascial pain according to RDC/TMD or DC/TMD N: 515 76.8% F Age range: adults Mean age range: 20–38 y |
5 From the inception of the database until September 2019 |
2002-2019 |
15 studies RCT 4 BoNT-A vs saline 1 BoNT-A vs Other treatment (dry needling) 1 No treatment |
Primary studies: Data extraction table Quality: Cochrane Handbook of Systematic Reviews |
1. Pain intensity (VAS) 2. PPT (algometer) 3. Mouth opening (mm) |
MD (95% CI) for relative effect sizes The treatment hierarchy was analyzed using SUCRA curve and mean ranks; GRADE for synthesis of evidence. |
|
|
Al-Moraissi, 2021 Yemen (Brazil, Saudi Arabia, China, Egypt, Sweden) NMA |
To identify the best treatment for adult patients with muscular TMD |
I: counseling therapy, occlusal appliances, manual therapy, injections of BoNT-A, LLLT, dry needling, LA, muscle relaxants, hypnosis/ relaxation therapy, oxidative ozone therapy C: placebo or no treatment |
Disorder: TMD myofascial pain (RDC/TMD or DC/TMD) N: 515 76.8% F Age range: adults Mean age range: 20–38 y |
5 From the inception of the database until August 2018 |
2002-2018 |
52 studies RCT |
Primary studies: Data extraction table Quality: Cochrane Handbook of Systematic Reviews |
1. Pain intensity (VAS) 2. PPT (algometer) 3. Mouth opening (mm) |
MD (95% CI) or SMD (95% CI) for relative effect sizes; The ranking probabilities for all treatments at each possible rank were investigated using SUCRA curve and mean ranks. GRADE for synthesis of evidence. |
|
|
Arribas-Pascual, 2023 Spain Umbrella MA |
To develop a mapping and umbrella review with a MA to synthesize and critically evaluate the current evidence for the effect of physiotherapy on TMD |
I: Any type of physiotherapeutic intervention alone or combined with other treatment techniques. C: placebo, BoNT-A, standard care treatment, or any other type of non-physiotherapeutic intervention |
Disorder: TMD (RDC/TMD or DC/TMD) N: 17,611, %F not reported Age range: Adults (> 18 y) Mean age range: Not reported |
5 From the inception of the database until January 2021 |
2006-2021 |
31 studies (15 SR, 16 MA) 10 studies included in MA 3 SR included BoNT-A |
Primary studies: Data extraction table Quality: AMSTAR 2, ROBIS tool |
1. Pain intensity (VAS) 2. MMO (mm) |
SMD (95% CI) for effect size PAGAC for synthesis of evidence A random-effects model Wa employed due to heterogeneous studies, |
MA could not be performed for dry needling intervention |
|
Awan, 2019 USA (Saudi Arabia, India UK) Review |
To evaluate the therapeutic efficacy of BoNT-A in the management of temporomandibular myofascial pain |
I: BoNT-A C: any alternative treatment or placebo |
Disorder: TMD according to RDC/TMD or DC/TMD N: 245 %F: Not reported Age range: Adults (> 18 y) Mean age range: Not reported |
4 From the inception of the database until Match 2018 |
2002-2012 |
7 studies RCT 5 BoNT-A vs saline 2 BoNT-A vs other treatment (LA, dry needling, fascial manipulation) |
Primary studies: Data extraction table Quality: Cochrane risk of bias tool |
1. Pain intensity (VAS) 2. PPT (algometer) 3. MUO (mm) |
Qualitative synthesis | MA could not be performed |
|
De la Torre Canales, 2017 Brazil SR |
To investigate the effects of BoNT-A injections in the management of bruxism |
I: BoNT-A C: other treatments |
Disorder: Bruxism N: 188 %F: 75.5% Age range: Adults Mean age range: 20.2–45 y |
7 January 1980 to March 2016 |
2005-2014 |
5 studies RCT, before-after 2 BoNT-A vs saline 1 BoNT-A vs other treatment regimens (injection masseter only or masseter and temporalis) 2 uncontrolled |
Primary studies: Data extraction table Quality: Cochrane Collaboration’s risk of bias tool for RCT, CASP (before after study) |
1. Pain relief 2. Jaw stiffness reduction 3. Decreased intensity 4. number of bruxism events |
Qualitative synthesis | |
|
De la Torre Canales, 2019 Brazil SR |
To investigate BoNT-A safety and adverse effects in the treatment of myofascial pain and trigeminal neuralgia |
I: BoNT-A C: other treatments |
Disorder: Myofascial pain (RDC or DC/TMD Or Trigeminal neuralgia (ICHD) N: 605 %F: Not reported Age range: Adults Mean age range: 18–71 y |
4 Time period not stated |
2002-2018 |
16 studies RCT, cohort 7 BoNT-A vs saline 4 BoNT-A vs other treatment regimens (fascial manipulation, two inj vs one, different age groups), MFP vs myalgia pat) 4 uncontrolled |
Primary studies: Data extraction table Quality: Cochrane Collaboration’s risk of bias tool for RCT, Critical Appraisal Skills Programme (CASP) (before after studies) |
1. Safety 2. Pain |
Qualitative synthesis | |
|
Delcanho, 2022 Australia (Italy) SR |
To review the scientific literature for evidence concerning the clinical use of BTX for the management of TMDs |
I: BoNT-A C: other treatment |
Disorder: TMD, bruxism, MFP, TMJ articular disc displacements, and/or any painful disorders involving the head and neck N: 698 %F: More women Age range: Not reported Mean age range: Not reported |
3 Time period not stated |
2002-2021 |
24 studies RCT 13 BoNT-A vs saline 7 BoNT-A vs other treatment (splint, fascial manipulation, LA, LLLT, dry needling) 3 other (BoNT-A vs BoNT-B, io vs eo inj, inj masseter only vs masseter and temporalis) 1 no control |
Primary studies: Data extraction table Quality: JADAD score |
1. Pain 2. MUO 3. Health-related QoL 4. AE |
Qualitative synthesis | MA could not be performed |
|
Di Francesco, 2022 Italy (Peru) SR |
To provide an overview of the use of BoNT-A in TMDs |
I: BoNT-A C: other treatment |
Disorder: TMD N: 527 %F: Not reported Age range: Adults Mean age range: Not reported |
3 January 2000 to 1 April 2022. |
2003-2021 |
10 studies RCT 7 BoNT-A vs saline 3 BoNT-A vs other treatments (splint, acupuncture, LA, facial manipulation) 1 no control |
Primary studies: Data extraction table Quality: Cochrane Collaboration’s risk of bias tool for RCT |
Clinical parameters such as orofacial pain and muscular diseases | Qualitative synthesis | |
|
Feng, 2019 China NMA |
To analyze current treatment modalities for TMD |
I: splint therapy, physiotherapy, pharmacotherapy, acupuncture or needling, psychological intervention, complementary therapy, bi-physiotherapy, trigger-point injection C: placebo |
Disorder: TMD (RDC or DC/TMD N: Not reported %F: 84.1% Age range: adults Mean age range: 21.2–40.9 y |
3 Until February 11, 2019 |
2011-2012 |
12 studies RCT 1 BoNT-A vs saline 1 BoNT-A vs other treatment (fascial manipulation9 |
Primary studies: Not reported Quality: Cochrane Collaboration’s risk of bias tool |
Pain intensity |
SMD (95% CI) and (95% predictive intervals, PrI) SCURA to show the probabilities of efficacy ranking among all treatment modalities |
No direct comparison BoNT-A vs placebo or other treatment, only as trigger point injection |
|
Griswold, 2023 USA SR |
To evaluate the comparative effectiveness of dry needling or local acupuncture to various types of wet needling for musculoskeletal pain disorders (MPD) |
I: Wet needling C: Dry needling or acupuncture |
Disorder: Individuals with MPD-related complaints of pain and/or disability N: %F: not reported Age range: adults Mean age range: Not reported |
7 Until October 31, 2019 |
2009-2019 |
26 studies RCT 2 BoNT-A vs ctr, in TMD |
Primary studies: Data extraction Quality: Cochrane Collaboration’s risk of bias tool |
1. Pain and/or disability |
Absolute mean differences compared to MCID < 6weeks (short-term), 7-25weeks (medium-term), and >26weeks (long-term) |
|
|
Khalife, 2016 USA MA |
To study the efficacy of BoNT-A in the treatment of myofascial pain syndrome |
I: BoNT-A C: placebo (saline) |
Disorder: MFP head and neck N: 656 %F: 71% Age range: 16–76 y Mean age range: Not reported |
3 Until June 1, 2016 |
1994-2016 |
13 studies RCT (3 in TMD) 3 BoNT-A vs placebo (saline) |
Primary studies: Data extraction Quality: Cochrane Handbook for Systematic Reviews of Interventions |
1. Pain reduction 2. number of responders 3. PPT |
RR (95% CI) and SDM (95% CI) |
|
|
Machado, 2018 Brazil SR |
To evaluate the effectiveness of dry needling and injection with different substances in TMD myofascial pai |
I: BoNT-A C: no treatment, placebo or other treatments (oral appliances, pharmacological therapies, trigger point inj, dry needling, laser, acupuncture, relaxation and physical therapies |
Disorder: TMD (Clinical examination) N: 260 %F: 81.8% Age range: 16–69 y Mean age range: Not reported |
6 Until January 2018 |
2002-2016 |
18 studies RCT 5 BoNT-A vs placebo (saline) 3 BoNT-A vs other treatment (LLLT, Fascial manipulation, Dry needling/LA) |
Primary studies: Data extraction Quality: Cochrane risk of bias tool |
1. Pain intensity 2. MUO |
Qualitative synthesis | |
|
Machado, 2020 Brazil MA |
To investigate the effectiveness and safety of BoNT-A for painful TMDs |
I: BoNT-A C: No treatment, placebo (saline) or other treatments |
Disorder: TMD (Clinical examination, DC/TMD, AAOP or bruxism) N: 362 %F: 87.2% Age range: 26–69 y Mean age range: Not reported |
10 From inception to February 12, 2019 |
2002-2016 |
12 studies RCT 9 BoNT-A vs placebo 2 BoNT-A vs no treatment 3 BoNT-A vs other treatment (LLLT, fascial manipulation, conventional treatment incl splint) |
Primary studies: Data extraction Quality: Cochrane risk of bias tool |
1. Pain relief 2.Health-related QoL 3. major AE 4. any AE |
Risk ratio (RR) (95% CI) and SDM (95% CI) When possible pooled data into meta-analyses using the random effects model GRADE for quality of evidence |
|
|
Moussa, 2023 Canada MA |
To investigate changes in mandibular bone following BoNT-A injections |
I: BoNT-A C: Placebo (saline), untreated side |
Disorder: TMD N: 304 %F: Not reported Age range: 26.9–55.3 y Mean age range: 35.5 y |
3 Until December 2022 |
2010-2020 |
36 studies Controlled (14 animal and 6 in human) 1 RCT 5 cohort |
Primary studies: Data extraction Quality: quality assessment tool tailored for human and animal studies, with maximum obtainable score of 10 points |
1. Change in mandibular bone volume and density, cortical thickness | Global effect size (DerSimonian Laird 2 estimator), unweighted mean difference (95% CI) | |
|
Owen, 2022 USA SR |
To evaluate the impact of BoNT-A injection into the masticatory muscles on mandibular bone |
I: BoNT-A C: Not stated |
Disorder: Not reported N: 320 %F: 97.5% Age range: Not reported Mean age range: 26.9–55.3 y |
5 PubMed, Embase, Ovid, CINAHL, Web of Science Until October 13, 2021 |
2011-2020 |
7 studies RCT and cohort 1 RCT 6 Cohort |
Primary studies: Data extraction Quality: Newcastle–Ottawa Scale for cohort studies and the Revised Cochrane Risk-of- Bias Tool for RCTs |
1. Presence of bony changes in mandible |
Qualitative synthesis GRADE for quality of evidence |
|
|
Ramos-Herrada, 2022 Peru (Brazil) SR |
To systematically review the effects of BoNT-A in patients with myofascial pain related to TMD |
I: BoNT-A C: Traditional methods |
Disorder: TMD N: 314 %F: 88.2% Age range: 18–75 y Mean age range: Not reported |
5 PubMed, Web of Science, Scopus, The Cochrane Library, and Latin American and Carribean Health Sciences Literature (LILACS) Up to February 2021 |
2011-2020 |
8 studies RCT 5 BoNT-A vs placebo (saline) 3 BoNT-A vs other treatment (fascial manipulation, LLLT, dry needling, LA, splint) |
Primary studies: Data extraction Quality: Cochrane Risk of Bias tool |
1. TMD-related MFP |
Qualitative synthesis MD (95% CIs) for changes were calculated GRADE for quality of evidence |
|
|
Zhang, 2011 Canada MA |
To examine the efficacy of BoNT-A in reducing chronic musculoskeletal pain |
I: BoNT-A C: |
Disorder: Chronic musculoskeletal pain N: 706 %F: Age range: all ages Mean age range: Not reported |
5 MEDLINE, EMBASE, PUBMED, Cochrane Central Register of Controlled Trials, CINAHL Up to 18 December 2008 |
2001-2008 |
15 studies RCT (8 MFP incl. 3 TMD) 8 BoNT-A vs saline |
Primary studies: Data extraction Quality: JADAD score (method) |
1. Pain severity |
Effect sizes, SMD (95% CI) Random-effects model |
BoNT-A botulinum toxin type A, CTR control, NMA network meta-analysis, MA meta-analysis, SR systematic review, RCT randomized controlled study,
TMD temporomandibular disorders, MFP myofascial pain, DC/TMD Diagnostic Criteria for TMD, RDC/TMD Research Diagnostic Criteria for TMD, ICOP International Classification for Orofacial Pain, ICHD International Headache Classification, SMD standard mean difference, MD mean difference, WMD weighted mean difference, MCID minimally clinically important difference, CI confidence interval, RR risk ratio, NNH number needed to harm, SUCRA surface under the cumulative ranking, MUO mouth opening, F females, QoL quality of life, AE adverse event, PPT pressure pin threshold, MTP myofascial trigger points, CASP Critical Appraisal Tool, CEBM Centre for Evidence-Based Medicine, CASP Critical Appraisal Skills Programme, PAGAC Physical Activity Guidelines Advisory Committee Grading, AMSTAR Assessing the Methodological Quality of Systematic Reviews, ROBIS risk of bias in systematic reviews