Here is the design of a clinical trial:

Official Title: Additional Effect of Pain Neuroscience Education to Orofacial Manual Therapy and Orofacial and Neck Motor Control Exercises for Pain Intensity and Disability in Temporomandibular Disorders: a Randomized Clinical Trial

Included conditions:
- Temporomandibular Disorders

Study Armgroups:
- {'label': 'Pain Neuroscience Education + orofacial and neck exercises', 'type': 'EXPERIMENTAL', 'description': 'All participants in this arm will initially receive two additional sessions in which a workshop on PNE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.', 'interventionNames': ['Other: Pain Neuroscience Education (PNE)', 'Other: Orofacial Manual Therapy', 'Other: Orofacial Exercises', 'Other: Neck Motor Control Exercises']}
- {'label': 'Orofacial and neck exercises', 'type': 'ACTIVE_COMPARATOR', 'description': 'A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.', 'interventionNames': ['Other: Orofacial Manual Therapy', 'Other: Orofacial Exercises', 'Other: Neck Motor Control Exercises']}

Interventions:
- {'type': 'OTHER', 'name': 'Pain Neuroscience Education (PNE)', 'description': 'A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. The intervention program will be divided into 17 thematic topics according to Explain Pain.', 'armGroupLabels': ['Pain Neuroscience Education + orofacial and neck exercises']}
- {'type': 'OTHER', 'name': 'Orofacial Manual Therapy', 'description': 'A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. The manual therapy techniques will be: Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}
- {'type': 'OTHER', 'name': 'Orofacial Exercises', 'description': 'Two mandibular exercises: Mandibular body-condylar cross-pressure chewing technique and Post-isometric relaxation stretches-laterotrusion and opening. Each exercise will be executed 10 times per session for 10 seconds.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}
- {'type': 'OTHER', 'name': 'Neck Motor Control Exercises', 'description': 'A protocol of neck motor control protocol will be adopted in our study. The exercises included bracing exercises (six hierarchical levels) in neurodevelopment stages for the cervical spine. Extremity range of motion exercises will be conducted while maintaining a stable spine at the specific positions. Also, cervical isometric exercises (five hierarchical levels) will be carried out directly forward, obliquely, toward right and left, and directly backward by maintaining a stable spine with elastic resistive bands. Finally, exercises also included functional training with elastic resistance and exercise balls on unstable surfaces (eight hierarchical levels). The criteria to progress in each exercise domain (bracing, isometric exercises or functional training) will be sustain the contraction for 10 seconds, 10 times.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}

Primary Outcomes:
- {'measure': 'Change in Pain intensity', 'description': 'The Numerical Pain Rating Scale will be used to assess pain intensity in this trial and consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".', 'timeFrame': 'Immediately after, one- and three-month follow-up'}
- {'measure': 'Change in Orofacial Pain related Disability', 'description': 'The Craniofacial Pain and Disability Inventory (CF-PDI) is a self-administered questionnaire that measures the outcomes of pain and disability related to craniofacial pain and demonstrated a good structure, internal consistency, reproducibility, and construct validity. Also, the Brazilian Portuguese version showed acceptable psychometric measurements. It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.', 'timeFrame': 'Immediately after, one- and three-month follow-up'}

Please estimate the sample size based on the assumption: 
The study assumes a power of 80%, an alpha of 5%, and f tests of 0.33 for pain intensity and 0.25 for disability. A follow-up loss of up to 15% is also considered.
Sample size calculation
        The study was designed to detect a between-group difference of 2 points in pain intensity (30%) measured by the NPRS, with an estimated standard deviation of 3 points. A previous study [42] recommended a minimum sample size of n=61 per group.
        For disability, a between-group difference of 5.08 points for disability measured by the CF-PDI, considering the Smallest Detectable Change of CF-PDI Brazilian version [26], with an estimated standard deviation of 10 points resulted in a sample size of 64 participants per group. The other specifications were power of 80%, an alpha of 5%, f test of 0.33 (pain intensity) and 0.25 (disability). Therefore, a total of 128 participants was obtained, however considering a follow-up loss up to 15%, we will recruit 148 participants. G*Power was used to run the sample size calculation (GPower 3.0.10, da University of Kiel, Germany).