scholarly journals Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
Julia Lam ◽  
Peter Svensson ◽  
Per Alstergren
Keyword(s):  
Pain Intensity ◽  
Temporomandibular Disorder ◽  
Functional Limitation ◽  
Pilot Trial ◽  
The Internet ◽  
Occlusal Splint ◽  
Splint Therapy ◽  
Randomized Controlled ◽  
Temporomandibular Pain

BACKGROUND Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. OBJECTIVE The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. METHODS An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. RESULTS Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: <i>P</i>=.58; 6 months: <i>P</i>=.41), pain-related disability (3 months: <i>P</i>=.51; 6 months: <i>P</i>=.12), jaw functional limitation (3 months: <i>P</i>=.45; 6 months: <i>P</i>=.90), degree of depression (3 months: <i>P</i>=.64; 6 months: <i>P</i>=.65), anxiety (3 months: <i>P</i>=.93; 6 months: <i>P</i>=.31), stress (3 months: <i>P</i>=.66; 6 months: <i>P</i>=.74), or catastrophizing (3 months: <i>P</i>=.86; 6 months: <i>P</i>=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, <i>P</i>=.04; Wilcoxon: z=–2.3, <i>P</i>=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, <i>P</i>=.045; Wilcoxon: z=–2.3, <i>P</i>=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, <i>P</i>=.01; Wilcoxon 3 months: z=–3.0, <i>P</i>=.003; Wilcoxon 6 months: z=-3.3, <i>P</i>=.001). CONCLUSIONS This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. CLINICALTRIAL ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762

scholarly journals Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial

10.2196/22326 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e22326
Author(s):  
Julia Lam ◽  
Peter Svensson ◽  
Per Alstergren
Keyword(s):  
Pain Intensity ◽  
Temporomandibular Disorder ◽  
Functional Limitation ◽  
Pilot Trial ◽  
The Internet ◽  
Occlusal Splint ◽  
Splint Therapy ◽  
Randomized Controlled ◽  
Temporomandibular Pain

Background Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. Objective The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. Methods An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. Results Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=–2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=–2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=–3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001). Conclusions This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. Trial Registration ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762

scholarly journals Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial.

2020 ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Guo-Wei Cai ◽  
Wen-Jun Wan ◽  
Xiao-Qing Zhou ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled

Abstract Background: Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation.Methods: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. 90 patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the Visual-Analogue Scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded.Discussion: The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration: ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9th March 2020).

scholarly journals Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Guo-Wei Cai ◽  
Wen-Jun Wan ◽  
Xiao-Qing Zhou ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. Methods This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. Discussion The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9 March 2020).

scholarly journals Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Oral Dexamethasone ◽  
Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

scholarly journals Randomized controlled trial of exercise interventions for chronic whiplash-associated disorders: One-year follow-up of the effect on neck muscle endurance, active cervical range of motion and grip strength.

2020 ◽  
Author(s):  
Gunnel Peterson ◽  
Maria Landén Ludvigsson ◽  
Anneli Peolsson
Keyword(s):  
Neck Pain ◽  
Pain Intensity ◽  
Grip Strength ◽  
Reference Values ◽  
Muscle Endurance ◽  
Neck Muscle ◽  
Exercise Interventions ◽  
Randomized Controlled ◽  
Whiplash Associated Disorders

Abstract Background: Years after whiplash injury, more than 40 % of people experience persistent neck pain and disability, called whiplash-associated disorders (WAD). The relations between neck related function, neck pain and disability are inconclusive and need to be further investigated. The aims were; a) to compare the effect of three different exercise interventions – neck-specific exercise (NSE), NSE with a behavioral approach (NSEB) and prescribed physical activity (PPA) – on neck-muscle endurance (NME), active cervical range of motion (AROM), grip strength and pain intensity immediately before and after the tests, and b) to compare neck-disability in individuals who are below or above the cut-off for normative reference values of healthy individuals regarding NME, AROM and grip strength.Methods: This is a secondary analysis of a randomized controlled multicenter study including 12 months’ follow-up. A total of 216 individuals with chronic WAD grades II or III were recruited. Data were recorded at baseline, 3, 6, and 12 months. Linear mixed models were used and sub-group analyses were evaluated with non-parametric tests.Results: NSE and NSEB resulted in greater improvements compared to PPA (p < .01) and were maintained at 12 months’ follow-up in ventral (only males) and dorsal NME, AROM and pain intensity during testing. In grip strength, there were no significant between-group differences (p > 0.05). There were no significant differences between the NSE and NSEB groups (p > .05). Sub-group analyses revealed improvement in disability at 12 months follow-up in NSE and/or NSEB for individuals both below and above the cut-off reference value in NME and AROM. More severe disability was seen in individuals below the reference values both at baseline and 12 months’ follow-up. Individuals in the PPA group below the reference values in NME and AROM reported increasing disability at 12 months compared to baseline.Conclusion: The results suggest that neck-specific exercises (NSE, NSEB) improved clinical function and decreased disability in chronic WAD compared to PPA. The results may imply that higher neck-related clinical function can be important for reduced disability. Trial Registration: ClinicalTrials.gov: NCT01528579, date of registration: February 8, 2012, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT0152857

scholarly journals Phototherapy versus Occlusal Splint to control painful symptoms in Temporomandibular Disorder: controlled, randomized cost-effectiveness clinical trial

2020 ◽  
Vol 9 (11) ◽  
pp. e66991110251
Author(s):  
Ana Paula Taboada Sobral ◽  
Sergio de Sousa Sobral ◽  
Glaucia Gurnhak Giacon ◽  
Thalita Molinos Campos ◽  
Anna Carolina Ratto Tempestini Horliana ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cost Effectiveness ◽  
Pain Intensity ◽  
Myofascial Pain ◽  
Positive Impact ◽  
Temporomandibular Disorder ◽  
Cost Effective ◽  
Cost Ratio ◽  
Occlusal Splint ◽  
Before And After

Objective: To compare the efficacy of photobiomodulation and occlusal splint in patients with TMD-associated myofascial pain. Material and methods: 23 patients were randomized into 2 groups: laser group (LG) (n = 12) and occlusal splint group (OSG) (n=11). For the LG, laser was applied to 3 points on each side of the face. Twelve applications were made, 2 sessions per week. In the OSG, patients were instructed to use the device during sleep, 8 hours per night, for a period of 6 weeks, and 12 adjustment and follow-up sessions were performed. Patients in both groups were reevaluated 30 days after the end of the treatments. Results: There was a decrease in pain intensity, according to a visual analogue scale, in both groups before and after 1 month (LG, p = 0.008 and OSG p = 0.002), but with no difference between groups. For the quality of life, both treatments had a positive impact, with this impact being higher in the LG compared to the OSG (p <0.05). Regarding the cost-effectiveness analysis, laser was more cost-effective than the occlusal splint in the clinical trial. The incremental cost of the laser was $3,483.45 compared to the splint, but it had a cost ratio of $4,569.02 for controlled pain intensity while the splint showed $6,691.91 ratio for controlled pain intensity. Conclusion: The photobiomodulation was more cost-effective in controlling painful symptoms in patients with TMD and myofascial pain.

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