Skip to main content
OpenTrials
Completed

NCT Number: NCT03320200

A Central Nervous System Focused Treatment Approach for Frozen Shoulder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Frozen Shoulder Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CNS-focused treatment

Other

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 names: graded motor and sensory imagery traininng

Standard Care Treatment

Other

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 names: Conventional physiotherapy treatment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2017
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.