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A Central Nervous System Focused Treatment Approach for Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT03320200
Recruitment Status : Unknown
Verified October 2017 by Enrique Lluch Girbés, University of Valencia.
Recruitment status was:  Recruiting
First Posted : October 25, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Enrique Lluch Girbés, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of Shoulder Frozen Shoulder Other: CNS-focused treatment Other: Standard Care Treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: 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
Other: CNS-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.
Other Name: graded motor and sensory imagery traininng

Experimental: 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
Other: Standard Care Treatment
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.
Other Name: Conventional physiotherapy treatment




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 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").

  2. Numeric Pain Rating Scale [ Time Frame: Change from baseline Numeric Rating Pain Scale at 10 weeks ]
    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").

  3. Numeric Pain Rating Scale [ Time Frame: Change from baseline Numeric Rating Pain Scale at 3 months ]
    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").

  4. Numeric Pain Rating Scale [ Time Frame: Change from baseline Numeric Rating Pain Scale at 6 months ]
    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").

  5. Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Baseline ]
    Degrees of active range of motion

  6. Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 10 weeks ]
    Degrees of active range of motion

  7. Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 3 months ]
    Degrees of active range of motion

  8. Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 6 months ]
    Degrees of active range of motion

  9. Two point discrimination threshold [ Time Frame: 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

  10. Two point discrimination threshold [ Time Frame: Change from baseline two point discrimination threshold at 10 weeks ]
    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

  11. Two point discrimination threshold [ Time Frame: Change from baseline two point discrimination threshold at 3 months ]
    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

  12. Two point discrimination threshold [ Time Frame: Change from baseline two point discrimination threshold at 6 months ]
    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

  13. Laterality judgement accuracy [ Time Frame: Baseline ]
    Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol

  14. Laterality judgement accuracy [ Time Frame: Change from baseline laterality judgement accuracy at 10 weeks ]
    Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol

  15. Laterality judgement accuracy [ Time Frame: Change from baseline laterality judgement accuracy at 3 months ]
    Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol

  16. Laterality judgement accuracy [ Time Frame: Change from baseline laterality judgement accuracy at 6 months ]
    Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol

  17. The Spanish version of the Tampa Scale of Kinesophobia (TSK-11) [ Time Frame: 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.

  18. The Spanish version of the Tampa Scale of Kinesophobia [ Time Frame: 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.

  19. The Spanish version of the Tampa Scale of Kinesophobia [ Time Frame: Change from baseline Tampa Scale of Kinesophobia at 3 months ]
    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.

  20. The Spanish version of the Tampa Scale of Kinesophobia [ Time Frame: Change from baseline Tampa Scale of Kinesophobia at 6 months ]
    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.

  21. The Patient Specific Functional Scale [ Time Frame: 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.

  22. The Patient Specific Functional Scale [ Time Frame: Change from baseline Patient Specific Functional Scale at 10 weeks ]
    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.

  23. The Patient Specific Functional Scale [ Time Frame: Change from baseline Patient Specific Functional Scale at 3 months ]
    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.

  24. The Patient Specific Functional Scale [ Time Frame: Change from baseline Patient Specific Functional Scale at 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320200


Contacts
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Contact: Silvia Mena, PhD student +34646362194 silmedel@uv.es

Locations
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Spain
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Lirios Dueñas, PhD    96 398 37 84    lirios.duenas@uv.es   
Sponsors and Collaborators
University of Valencia
Investigators
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Study Director: Enrique Lluch, PhD Physiotherapy Department University of Valencia

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrique Lluch Girbés, PhD Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03320200     History of Changes
Other Study ID Numbers: H1507114540624
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases