Adhesive Capsulitis of Shoulder, Frozen Shoulder
Conditions
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.
Interventions
OTHERCNS-focused treatment
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.
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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| shoulder pain-related disability questionnaire (SPADI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goniometric assessment of active shoulder ROM (range of motion) | Baseline | Degrees of active range of motion |
| Two point discrimination threshold | Baseline | 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 |
| Laterality judgement accuracy | Baseline | Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol |
| Numeric Pain Rating Scale | Baseline | 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). |
| The Spanish version of the Tampa Scale of Kinesophobia | Change from baseline Tampa Scale of Kinesophobia at 10 weeks | 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. |
| The Patient Specific Functional Scale | Baseline | 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. |
| The Spanish version of the Tampa Scale of Kinesophobia (TSK-11) | Baseline | 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. |
Countries
Spain
Outcome results
None listed