A Central Nervous System Focused Treatment Approach for Frozen Shoulder

Study Overview
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Brief Summary
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The aim of this study is to compare the effectiveness of a CNS-directed treatment program versus a standard medical and physiotherapy care program on outcomes in participants with FS.Participants will be randomized to receive either a 10 weeks CNS-focused treatment program or standard medical and physiotherapy care.To evaluate the results of the interventions, the subjects will be assessed at the beginning, at the end of the treatment program (week 10) and at 3 and 6 months of follow-up.

Detailed Description
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The aim of this study is to compare the effectiveness of a CNS-directed treatment program versus a standard medical and physiotherapy care program on outcomes in participants with Frozen Shoulder (FS). It will consist of a randomized double-blind clinical trial (both participants and evaluators). The sample will consist of subjects with primary or idiopathic FS. Once the sample is selected, participants will be randomly assigned to receive either a CNS-centered treatment program or a standard physiotherapy program. The CNS-centered treatment program 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. On the other hand, subjects assigned to the standard physiotherapy group will receive a 10-session treatment program, such as the CNS-centered treatment group. This standard treatment 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. Physiotherapists will be instructed not to include interventions that were similar to those used in the group receiving the CNS-focused protocol (e.g. using mirrors or imagined movements) and to include a home program that involves a training load comparable to that in the other group. Adherence to both interventions will be monitored using an individual treatment diary where the time of day and duration of each clinic and home session will be recorded To evaluate the results of the interventions, the subjects will be assessed at the beginning, at the end of the treatment program (week 10) and at 3 and 6 months of follow-up.

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

Conditions
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Adhesive Capsulitis of Shoulder, Frozen Shoulder

Intervention / Treatment
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* Other: CNS-focused treatment
* Other: Standard Care Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary or idiopathic Frozen Shoulder (FS), defined as FS not associated with a systemic condition or history of injury greater than 50% reduction in passive external rotation when compared to the uninvolved shoulder or less than 30° of external rotation range of motion loss of greater than 25% in at least two movement planes in comparison to the uninvolved shoulder pain and restricted movement present for at least one month reaching a plateau or worsening normal shoulder X-rays (with the exception of osteopenia of the humeral head and calcific tendinosis) Exclusion Criteria: Locked dislocations, arthritis, fractures or avascular necrosis on radiographs surgery in the upper quadrant region <12 months prior to the study skin or medical conditions that prevents from receiving tactile stimuli on the shoulder neurological or motor disorders including a diagnosis of dyslexia or difficulty performing a rapid naming task visually and mental health conditions that precludes successful participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNS-focused treatment<br>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 | Other: CNS-focused treatment<br>* 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.<br>* Other names: graded motor and sensory imagery traininng;|
| Experimental: Standard Care Treatment<br>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 | Other: Standard Care Treatment<br>* 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.<br>* Other names: Conventional physiotherapy treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain-related disability questionnaire (SPADI) | 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. | Baseline | 
| shoulder pain-related disability questionnaire (SPADI) | 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. | Change from baseline SPADI at 10 weeks | 
| shoulder pain-related disability questionnaire (SPADI) | 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. | Change from baseline SPADI at 3 months | 
| shoulder pain-related disability questionnaire (SPADI) | 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. | Change from baseline SPADI at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | a valid and reliable measure of shoulder pain. Participants will be presented with numerical rating scales anchored with 0 (no pain) and 10 (pain as bad as you can imagine). | Baseline | 
| Numeric Pain Rating Scale | a valid and reliable measure of shoulder pain. Participants will be presented with numerical rating scales anchored with 0 (no pain) and 10 (pain as bad as you can imagine). | Change from baseline Numeric Rating Pain Scale at 10 weeks | 
| Numeric Pain Rating Scale | a valid and reliable measure of shoulder pain. Participants will be presented with numerical rating scales anchored with 0 (no pain) and 10 (pain as bad as you can imagine). | Change from baseline Numeric Rating Pain Scale at 3 months | 
| Numeric Pain Rating Scale | a valid and reliable measure of shoulder pain. Participants will be presented with numerical rating scales anchored with 0 (no pain) and 10 (pain as bad as you can imagine). | Change from baseline Numeric Rating Pain Scale at 6 months | 
| Goniometric assessment of active shoulder ROM (range of motion) | Degrees of active range of motion | Baseline | 
| Goniometric assessment of active shoulder ROM (range of motion) | Degrees of active range of motion | Change from baseline ROM at 10 weeks | 
| Goniometric assessment of active shoulder ROM (range of motion) | Degrees of active range of motion | Change from baseline ROM at 3 months | 
| Goniometric assessment of active shoulder ROM (range of motion) | Degrees of active range of motion | Change from baseline ROM at 6 months | 
| Two point discrimination threshold | Two point discrimination threshold measured at one standardize site on the affected shoulder (5cm distal to the lateral border of the acromion) 33, following an established protocol | Baseline | 
| Two point discrimination threshold | Two point discrimination threshold measured at one standardize site on the affected shoulder (5cm distal to the lateral border of the acromion) 33, following an established protocol | Change from baseline two point discrimination threshold at 10 weeks | 
| Two point discrimination threshold | Two point discrimination threshold measured at one standardize site on the affected shoulder (5cm distal to the lateral border of the acromion) 33, following an established protocol | Change from baseline two point discrimination threshold at 3 months | 
| Two point discrimination threshold | Two point discrimination threshold measured at one standardize site on the affected shoulder (5cm distal to the lateral border of the acromion) 33, following an established protocol | Change from baseline two point discrimination threshold at 6 months | 
| Laterality judgement accuracy | Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol | Baseline | 
| Laterality judgement accuracy | Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol | Change from baseline laterality judgement accuracy at 10 weeks | 
| Laterality judgement accuracy | Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol | Change from baseline laterality judgement accuracy at 3 months | 
| Laterality judgement accuracy | Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol | Change from baseline laterality judgement accuracy at 6 months | 
| The Spanish version of the Tampa Scale of Kinesophobia (TSK-11) | The TSK-11 is an 11-item questionnaire assessing fear of movement or fear of (re)injury during movement. It is comprised of 11 items each ranged on a 4-point scale with the end points (1) totally agree and (4) totally disagree (range: 11-44). Higher scores indicate more fear-avoidance behavior. | Baseline | 
| The Spanish version of the Tampa Scale of Kinesophobia | The TSK-11 is an 11-item questionnaire assessing fear of movement or fear of (re)injury during movement. It is comprised of 11 items each ranged on a 4-point scale with the end points (1) totally agree and (4) totally disagree (range: 11-44). Higher scores indicate more fear-avoidance behavior. | Change from baseline Tampa Scale of Kinesophobia at 10 weeks | 
| The Spanish version of the Tampa Scale of Kinesophobia | The TSK-11 is an 11-item questionnaire assessing fear of movement or fear of (re)injury during movement. It is comprised of 11 items each ranged on a 4-point scale with the end points (1) totally agree and (4) totally disagree (range: 11-44). Higher scores indicate more fear-avoidance behavior. | Change from baseline Tampa Scale of Kinesophobia at 3 months | 
| The Spanish version of the Tampa Scale of Kinesophobia | The TSK-11 is an 11-item questionnaire assessing fear of movement or fear of (re)injury during movement. It is comprised of 11 items each ranged on a 4-point scale with the end points (1) totally agree and (4) totally disagree (range: 11-44). Higher scores indicate more fear-avoidance behavior. | Change from baseline Tampa Scale of Kinesophobia at 6 months | 
| The Patient Specific Functional Scale | A list of activities and movements is shown to the patients and they are asked to identify the activities that he/she experience difficulty with because of his/her complaints in the shoulder. The patient selects the 3 most important activities and rank them by degree of importance from 0 (no difficulty at all) to 10 (impossible). The total score range from 0 to 30. Higher score indicates higher difficulty in performance on daily activities. | Baseline | 
| The Patient Specific Functional Scale | A list of activities and movements is shown to the patients and they are asked to identify the activities that he/she experience difficulty with because of his/her complaints in the shoulder. The patient selects the 3 most important activities and rank them by degree of importance from 0 (no difficulty at all) to 10 (impossible). The total score range from 0 to 30. Higher score indicates higher difficulty in performance on daily activities. | Change from baseline Patient Specific Functional Scale at 10 weeks | 
| The Patient Specific Functional Scale | A list of activities and movements is shown to the patients and they are asked to identify the activities that he/she experience difficulty with because of his/her complaints in the shoulder. The patient selects the 3 most important activities and rank them by degree of importance from 0 (no difficulty at all) to 10 (impossible). The total score range from 0 to 30. Higher score indicates higher difficulty in performance on daily activities. | Change from baseline Patient Specific Functional Scale at 3 months | 
| The Patient Specific Functional Scale | A list of activities and movements is shown to the patients and they are asked to identify the activities that he/she experience difficulty with because of his/her complaints in the shoulder. The patient selects the 3 most important activities and rank them by degree of importance from 0 (no difficulty at all) to 10 (impossible). The total score range from 0 to 30. Higher score indicates higher difficulty in performance on daily activities. | Change from baseline Patient Specific Functional Scale at 6 months |