Here is the design of a clinical trial:

Official Title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial

Included conditions:
- Adhesive Capsulitis of Shoulder
- Frozen Shoulder

Study Armgroups:
- {'label': 'CNS-focused treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week CNS (Central Nervous System) -focused treatment program for frozen shoulder in addition to 5 days per week home treatment program', 'interventionNames': ['Other: CNS-focused treatment']}
- {'label': 'Standard Care Treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week standard care treatment program for frozen shoulder in addition to 5 days per week home treatment program based on conventional physiotherapy', 'interventionNames': ['Other: Standard Care Treatment']}

Interventions:
- {'type': 'OTHER', 'name': 'CNS-focused treatment', 'description': 'The CNS-focused treatment will last for 10 weeks, conducted in 60-minute sessions on a weekly basis. In addition, participants in this group will complete a home treatment program for 30 minutes, five times a week.', 'armGroupLabels': ['CNS-focused treatment'], 'otherNames': ['graded motor and sensory imagery traininng']}
- {'type': 'OTHER', 'name': 'Standard Care Treatment', 'description': 'The standard physiotherapy group will receive a 10-session treatment program that will include one corticosteroid infiltration provided in the early acute stage followed by a multimodal physiotherapy program including analgesic modalities (e.g. TENS, cryotherapy) and exercise and manual therapy techniques addressing the specific mobility deficits of each patient. This program also include a home treatment based on conventional physiotherapy that involves a training load comparable to that in the CNS-focused group.', 'armGroupLabels': ['Standard Care Treatment'], 'otherNames': ['Conventional physiotherapy treatment']}

Primary Outcomes:
- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Baseline'}
- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 10 weeks'}
- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 3 months'}
- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 6 months'}

Please estimate the sample size based on the assumption: 
80% power, alpha level of 0.05, 15% dropout rate.
Statistical analysis including sample size calculation
        
          Sample size calculations
          The sample size will be calculated using G*Power 3.0.18 Software based on the SPADI as the primary outcome measure. To our knowledge, there are no studies investigating the effects of GMI or graded sensory discrimination training on FS. Based on similar studies applying physiotherapy on FS (SPADI mean of 66 points; standard deviation (SD) = 16) [8], and the minimal detectable change attained in the study by Tveita et al. (17 points) [41], to detect a 17-point (SDâ=â16) between-group difference, with 80% power and an alpha level of 0.05, a total sample size of 30 patients is estimated (15 per group). An allowance will be made for a 15% dropout rate, increasing the sample size to 34 patients (17 per group). However, since this calculation is not based in the use of GMI, to assure an adequate sample size, we will carry out a pilot study with 20 participants (10 per group) to test these assumptions. Mean differences and standard deviations from the inter-group comparison on the primary outcome (SPADI) will then be used to recalculate the sample size, if necessary.
        
        
          Statistical analysis
          Data will be analyzed using the statistical package SPSS 21.00 for Windows. Statistical significance will be set at pâ<â0.05. Prior to statistical comparisons, all data will be tested for normal distribution. Then, a descriptive analysis of the data will be obtained for the dependent variables in the different assessment times. Subsequently, homogeneity of the two intervention groups will be studied. To confirm if there are differences in each group (intra-group comparisons), considering each group in isolation, between the four assessments in each of the variables (baseline, post treatment, 3-month follow-up, 6-month follow-up), repeated measures analysis of variance ANOVA will be used. To calculate inter-group differences between baseline and follow-ups, a four-way repeated-measures ANOVA will be conducted, with the scores of every primary and secondary outcome as dependent factors, with four levels corresponding to every time of assessment (t1, t2, t3 and t4), and the two intervention groups (CNS-focused treatment vs standard care treatment) as independent factors. Between- and within-group effect sizes for all quantitative variables will be measured with the Cohen d coefficient. An effect size greater than 0.8 will be considered large, around 0.5 moderate, and less than 0.2 small [42]. In cases of missing data, an intention-to-treat analysis will be performed. Double data entry will be carried out in order to promote data quality.