A Central Nervous System Focused Treatment Approach for Frozen Shoulder

University of Valencia

Status: Completed

Conditions: Adhesive Capsulitis of Shoulder; Frozen Shoulder

Treatments: Other: CNS-focused treatment; Other: Standard Care Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03320200

H1507114540624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

CNS-focused treatment

Experimental group

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

Treatment:

Other: CNS-focused treatment

Standard Care Treatment

Experimental group

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

Treatment:

Other: Standard Care Treatment