A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- shoulder pain-related disability questionnaire (SPADI)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CNS-focused treatment
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
Intervention: CNS-focused treatment (Other)
Standard Care Treatment
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
Intervention: Standard Care Treatment (Other)
Outcomes
Primary Outcomes
shoulder pain-related disability questionnaire (SPADI)
Time Frame: Change from baseline SPADI at 6 months
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.
shoulder pain-related disability questionnaire (SPADI)
Time Frame: Baseline
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.
shoulder pain-related disability questionnaire (SPADI)
Time Frame: Change from baseline SPADI at 10 weeks
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.
shoulder pain-related disability questionnaire (SPADI)
Time Frame: Change from baseline SPADI at 3 months
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.
Secondary Outcomes
- The Spanish version of the Tampa Scale of Kinesophobia (TSK-11)(Baseline)
- Laterality judgement accuracy(Change from baseline laterality judgement accuracy at 6 months)
- The Spanish version of the Tampa Scale of Kinesophobia(Change from baseline Tampa Scale of Kinesophobia at 6 months)
- The Patient Specific Functional Scale(Change from baseline Patient Specific Functional Scale at 6 months)
- Two point discrimination threshold(Change from baseline two point discrimination threshold at 6 months)
- Numeric Pain Rating Scale(Change from baseline Numeric Rating Pain Scale at 6 months)
- Goniometric assessment of active shoulder ROM (range of motion)(Change from baseline ROM at 6 months)
- Numeric Pain Rating Scale(Baseline)
- Numeric Pain Rating Scale(Change from baseline Numeric Rating Pain Scale at 10 weeks)
- Numeric Pain Rating Scale(Change from baseline Numeric Rating Pain Scale at 3 months)
- Goniometric assessment of active shoulder ROM (range of motion)(Baseline)
- Goniometric assessment of active shoulder ROM (range of motion)(Change from baseline ROM at 10 weeks)
- Goniometric assessment of active shoulder ROM (range of motion)(Change from baseline ROM at 3 months)
- Two point discrimination threshold(Baseline)
- Two point discrimination threshold(Change from baseline two point discrimination threshold at 10 weeks)
- Two point discrimination threshold(Change from baseline two point discrimination threshold at 3 months)
- Laterality judgement accuracy(Baseline)
- Laterality judgement accuracy(Change from baseline laterality judgement accuracy at 10 weeks)
- Laterality judgement accuracy(Change from baseline laterality judgement accuracy at 3 months)
- The Spanish version of the Tampa Scale of Kinesophobia(Change from baseline Tampa Scale of Kinesophobia at 10 weeks)
- The Spanish version of the Tampa Scale of Kinesophobia(Change from baseline Tampa Scale of Kinesophobia at 3 months)
- The Patient Specific Functional Scale(Baseline)
- The Patient Specific Functional Scale(Change from baseline Patient Specific Functional Scale at 10 weeks)
- The Patient Specific Functional Scale(Change from baseline Patient Specific Functional Scale at 3 months)
Investigators
Enrique Lluch Girbés
PhD Professor
University of Valencia