Clinical trial NCT03320200: A Central Nervous System Focused Treatment Approach for Frozen Shoulder
Official title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Frozen Shoulder
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: shoulder pain-related disability questionnaire (SPADI)
timeFrame: Baseline
measure: shoulder pain-related disability questionnaire (SPADI)
timeFrame: Change from baseline SPADI at 10 weeks
measure: shoulder pain-related disability questionnaire (SPADI)
timeFrame: Change from baseline SPADI at 3 months
measure: shoulder pain-related disability questionnaire (SPADI)
timeFrame: Change from baseline SPADI at 6 months
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline
measure: Numeric Pain Rating Scale
timeFrame: Change from baseline Numeric Rating Pain Scale at 10 weeks
measure: Numeric Pain Rating Scale
timeFrame: Change from baseline Numeric Rating Pain Scale at 3 months
measure: Numeric Pain Rating Scale
timeFrame: Change from baseline Numeric Rating Pain Scale at 6 months
measure: Goniometric assessment of active shoulder ROM (range of motion)
timeFrame: Baseline
measure: Goniometric assessment of active shoulder ROM (range of motion)
timeFrame: Change from baseline ROM at 10 weeks
measure: Goniometric assessment of active shoulder ROM (range of motion)
timeFrame: Change from baseline ROM at 3 months
measure: Goniometric assessment of active shoulder ROM (range of motion)
timeFrame: Change from baseline ROM at 6 months
measure: Two point discrimination threshold
timeFrame: Baseline
measure: Two point discrimination threshold
timeFrame: Change from baseline two point discrimination threshold at 10 weeks
measure: Two point discrimination threshold
timeFrame: Change from baseline two point discrimination threshold at 3 months
measure: Two point discrimination threshold
timeFrame: Change from baseline two point discrimination threshold at 6 months
measure: Laterality judgement accuracy
timeFrame: Baseline
measure: Laterality judgement accuracy
timeFrame: Change from baseline laterality judgement accuracy at 10 weeks
measure: Laterality judgement accuracy
timeFrame: Change from baseline laterality judgement accuracy at 3 months
measure: Laterality judgement accuracy
timeFrame: Change from baseline laterality judgement accuracy at 6 months
measure: The Spanish version of the Tampa Scale of Kinesophobia (TSK-11)
timeFrame: Baseline
measure: The Spanish version of the Tampa Scale of Kinesophobia
timeFrame: Change from baseline Tampa Scale of Kinesophobia at 10 weeks
measure: The Spanish version of the Tampa Scale of Kinesophobia
timeFrame: Change from baseline Tampa Scale of Kinesophobia at 3 months
measure: The Spanish version of the Tampa Scale of Kinesophobia
timeFrame: Change from baseline Tampa Scale of Kinesophobia at 6 months
measure: The Patient Specific Functional Scale
timeFrame: Baseline
measure: The Patient Specific Functional Scale
timeFrame: Change from baseline Patient Specific Functional Scale at 10 weeks
measure: The Patient Specific Functional Scale
timeFrame: Change from baseline Patient Specific Functional Scale at 3 months
measure: The Patient Specific Functional Scale
timeFrame: Change from baseline Patient Specific Functional Scale at 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Physiotherapy Department University of Valencia
name: Enrique Lluch, PhD
role: STUDY_DIRECTOR
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