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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

Tracking Information
First Submitted Date  ICMJE October 12, 2017
First Posted Date  ICMJE October 25, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03320200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
  • 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").
  • 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").
  • 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").
  • 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").
  • Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Baseline ]
    Degrees of active range of motion
  • Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 10 weeks ]
    Degrees of active range of motion
  • Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 3 months ]
    Degrees of active range of motion
  • Goniometric assessment of active shoulder ROM (range of motion) [ Time Frame: Change from baseline ROM at 6 months ]
    Degrees of active range of motion
  • 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
  • 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
  • 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
  • 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
  • Laterality judgement accuracy [ Time Frame: Baseline ]
    Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Central Nervous System Focused Treatment Approach for Frozen Shoulder
Official Title  ICMJE A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Adhesive Capsulitis of Shoulder
  • Frozen Shoulder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Other: CNS-focused treatment
  • 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
    Intervention: Other: Standard Care Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 19, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03320200
Other Study ID Numbers  ICMJE H1507114540624
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enrique Lluch Girbés, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Enrique Lluch, PhD Physiotherapy Department University of Valencia
PRS Account University of Valencia
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP