Adhesive Capsulitis of ShoulderNCT03320200
A Central Nervous System Focused Treatment Approach for Frozen Shoulder
A study testing CNS-focused treatment in people with Adhesive Capsulitis of Shoulder and Frozen Shoulder, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis of Shoulder, Frozen Shoulder
- What is being tested?
- CNS-focused treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
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.
Read the 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.
- Conditions
- Adhesive Capsulitis of Shoulder, Frozen Shoulder
- Being tested
- CNS-focused treatment, Standard Care Treatment
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNS-focused treatmentOther
Also called graded motor and sensory imagery traininng
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.
Standard Care TreatmentOther
Also called Conventional physiotherapy 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.
| Study group | Role | What they receive |
|---|---|---|
| CNS-focused treatment | Experimental | 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 Receives: Other: CNS-focused treatment |
| Standard Care Treatment | Experimental | 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 Receives: Other: Standard Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder pain-related disability questionnaire (SPADI)
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.
Measured: Baseline
shoulder pain-related disability questionnaire (SPADI)
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.
Measured: Change from baseline SPADI at 10 weeks
shoulder pain-related disability questionnaire (SPADI)
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.
Measured: Change from baseline SPADI at 3 months
shoulder pain-related disability questionnaire (SPADI)
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.
Measured: Change from baseline SPADI at 6 months
Secondary outcomes (24)
Numeric Pain Rating Scale
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").
Measured: Baseline
Numeric Pain Rating Scale
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").
Measured: Change from baseline Numeric Rating Pain Scale at 10 weeks
Numeric Pain Rating Scale
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").
Measured: Change from baseline Numeric Rating Pain Scale at 3 months
Numeric Pain Rating Scale
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").
Measured: Change from baseline Numeric Rating Pain Scale at 6 months
Goniometric assessment of active shoulder ROM (range of motion)
Degrees of active range of motion
Measured: Baseline
Goniometric assessment of active shoulder ROM (range of motion)
Degrees of active range of motion
Measured: Change from baseline ROM at 10 weeks
Goniometric assessment of active shoulder ROM (range of motion)
Degrees of active range of motion
Measured: Change from baseline ROM at 3 months
Goniometric assessment of active shoulder ROM (range of motion)
Degrees of active range of motion
Measured: Change from baseline ROM at 6 months
Two point discrimination threshold
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
Measured: Baseline
Two point discrimination threshold
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
Measured: Change from baseline two point discrimination threshold at 10 weeks
Two point discrimination threshold
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
Measured: Change from baseline two point discrimination threshold at 3 months
Two point discrimination threshold
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
Measured: Change from baseline two point discrimination threshold at 6 months
Laterality judgement accuracy
Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol
Measured: Baseline
Laterality judgement accuracy
Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol
Measured: Change from baseline laterality judgement accuracy at 10 weeks
Laterality judgement accuracy
Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol
Measured: Change from baseline laterality judgement accuracy at 3 months
Laterality judgement accuracy
Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol
Measured: Change from baseline laterality judgement accuracy at 6 months
The Spanish version of the Tampa Scale of Kinesophobia (TSK-11)
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.
Measured: Baseline
The Spanish version of the Tampa Scale of Kinesophobia
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.
Measured: Change from baseline Tampa Scale of Kinesophobia at 10 weeks
The Spanish version of the Tampa Scale of Kinesophobia
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.
Measured: Change from baseline Tampa Scale of Kinesophobia at 3 months
The Spanish version of the Tampa Scale of Kinesophobia
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.
Measured: Change from baseline Tampa Scale of Kinesophobia at 6 months
The Patient Specific Functional Scale
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.
Measured: Baseline
The Patient Specific Functional Scale
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.
Measured: Change from baseline Patient Specific Functional Scale at 10 weeks
The Patient Specific Functional Scale
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.
Measured: Change from baseline Patient Specific Functional Scale at 3 months
The Patient Specific Functional Scale
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.
Measured: Change from baseline Patient Specific Functional Scale at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Oct 2017
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Lluch Girbés, University of Valencia
- Investigators
- Enrique Lluch, PhD, Study director, Physiotherapy Department University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320200
- Sponsor's protocol ID
- H1507114540624
- Status last verified
- Jul 2022
- First submitted
- 12 Oct 2017
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wand BM, O'Connell NE, Di Pietro F, Bulsara M. Managing chronic nonspecific low back pain with a sensorimotor retraining approach: exploratory multiple-baseline study of 3 participants. Phys Ther. 2011 Apr;91(4):535-46. doi: 10.2522/ptj.20100150. Epub 2011 Feb 24.
PubMed 21350034Louw A, Puentedura EJ, Reese D, Parker P, Miller T, Mintken PE. Immediate Effects of Mirror Therapy in Patients With Shoulder Pain and Decreased Range of Motion. Arch Phys Med Rehabil. 2017 Oct;98(10):1941-1947. doi: 10.1016/j.apmr.2017.03.031. Epub 2017 May 5.
PubMed 28483657Moseley GL. Do training diaries affect and reflect adherence to home programs? Arthritis Rheum. 2006 Aug 15;55(4):662-4. doi: 10.1002/art.22086. No abstract available.
PubMed 16874790Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Moseley G, Butler D, Beames T, Giles T. The graded motor imagery handbook. Adelaide: Noigroup Publishing; 2012.
Desroches G, Desmeules F, Gagnon DH. Characterization of humeral head displacements during dynamic glenohumeral neuromuscular control exercises using quantitative ultrasound imaging: A feasibility study. Musculoskelet Sci Pract. 2017 Jun;29:150-154. doi: 10.1016/j.msksp.2016.12.004. Epub 2016 Dec 11.
PubMed 28715302Mottram SL, Woledge RC, Morrissey D. Motion analysis study of a scapular orientation exercise and subjects' ability to learn the exercise. Man Ther. 2009 Feb;14(1):13-8. doi: 10.1016/j.math.2007.07.008. Epub 2007 Oct 1.
PubMed 17910930Mena-Del Horno S, Balasch-Bernat M, Duenas L, Reis F, Louw A, Lluch E. Laterality judgement and tactile acuity in patients with frozen shoulder: A cross-sectional study. Musculoskelet Sci Pract. 2020 Jun;47:102136. doi: 10.1016/j.msksp.2020.102136. Epub 2020 Feb 24.
PubMed 32148332Lluch-Girbes E, Duenas L, Mena-Del Horno S, Luque-Suarez A, Navarro-Ledesma S, Louw A. A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial. Trials. 2019 Aug 13;20(1):498. doi: 10.1186/s13063-019-3585-z.
PubMed 31409380
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03320200
- Acronym / sponsor ID
- H1507114540624
- Conditions
- Adhesive Capsulitis of Shoulder, Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNS-focused treatment | Experimental | Other: CNS-focused treatmentGroup 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 |
| Standard Care Treatment | Experimental | Other: Standard Care TreatmentGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNS-focused treatmentAlso: graded motor and sensory imagery traininngThe 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 | CNS-focused treatment |
| Standard Care TreatmentAlso: Conventional physiotherapy treatmentThe 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 | Standard Care Treatment |
Primary outcome
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.
24 secondary outcomes
Numeric Pain Rating Scale
Time frame: Baseline
Numeric Pain Rating Scale
Time frame: Change from baseline Numeric Rating Pain Scale at 10 weeks
Numeric Pain Rating Scale
Time frame: Change from baseline Numeric Rating Pain Scale at 3 months
Numeric Pain Rating Scale
Time frame: Change from baseline Numeric Rating Pain Scale at 6 months
Goniometric assessment of active shoulder ROM (range of motion)
Time frame: Baseline
Goniometric assessment of active shoulder ROM (range of motion)
Time frame: Change from baseline ROM at 10 weeks
Goniometric assessment of active shoulder ROM (range of motion)
Time frame: Change from baseline ROM at 3 months
Goniometric assessment of active shoulder ROM (range of motion)
Time frame: Change from baseline ROM at 6 months
Two point discrimination threshold
Time frame: Baseline
Two point discrimination threshold
Time frame: Change from baseline two point discrimination threshold at 10 weeks
Two point discrimination threshold
Time frame: Change from baseline two point discrimination threshold at 3 months
Two point discrimination threshold
Time frame: Change from baseline two point discrimination threshold at 6 months
Laterality judgement accuracy
Time frame: Baseline
Laterality judgement accuracy
Time frame: Change from baseline laterality judgement accuracy at 10 weeks
Laterality judgement accuracy
Time frame: Change from baseline laterality judgement accuracy at 3 months
Laterality judgement accuracy
Time frame: Change from baseline laterality judgement accuracy at 6 months
The Spanish version of the Tampa Scale of Kinesophobia (TSK-11)
Time frame: Baseline
The Spanish version of the Tampa Scale of Kinesophobia
Time frame: Change from baseline Tampa Scale of Kinesophobia at 10 weeks
The Spanish version of the Tampa Scale of Kinesophobia
Time frame: Change from baseline Tampa Scale of Kinesophobia at 3 months
The Spanish version of the Tampa Scale of Kinesophobia
Time frame: Change from baseline Tampa Scale of Kinesophobia at 6 months
The Patient Specific Functional Scale
Time frame: Baseline
The Patient Specific Functional Scale
Time frame: Change from baseline Patient Specific Functional Scale at 10 weeks
The Patient Specific Functional Scale
Time frame: Change from baseline Patient Specific Functional Scale at 3 months
The Patient Specific Functional Scale
Time frame: Change from baseline Patient Specific Functional Scale at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Results publication: PubMed 21350034Wand BM, O'Connell NE, Di Pietro F, Bulsara M. Managing chronic nonspecific low back pain with a sensorimotor retraining approach: exploratory multiple-baseline study of 3 participants. Phys Ther. 2011 Apr;91(4):535-46. doi: 10.2522/ptj.20100150. Epub 2011 Feb 24.
- Results publication: PubMed 28483657Louw A, Puentedura EJ, Reese D, Parker P, Miller T, Mintken PE. Immediate Effects of Mirror Therapy in Patients With Shoulder Pain and Decreased Range of Motion. Arch Phys Med Rehabil. 2017 Oct;98(10):1941-1947. doi: 10.1016/j.apmr.2017.03.031. Epub 2017 May 5.
- Results publication: PubMed 16874790Moseley GL. Do training diaries affect and reflect adherence to home programs? Arthritis Rheum. 2006 Aug 15;55(4):662-4. doi: 10.1002/art.22086. No abstract available.
- Results publication: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Results publicationMoseley G, Butler D, Beames T, Giles T. The graded motor imagery handbook. Adelaide: Noigroup Publishing; 2012.
- Results publication: PubMed 28715302Desroches G, Desmeules F, Gagnon DH. Characterization of humeral head displacements during dynamic glenohumeral neuromuscular control exercises using quantitative ultrasound imaging: A feasibility study. Musculoskelet Sci Pract. 2017 Jun;29:150-154. doi: 10.1016/j.msksp.2016.12.004. Epub 2016 Dec 11.
- Results publication: PubMed 17910930Mottram SL, Woledge RC, Morrissey D. Motion analysis study of a scapular orientation exercise and subjects' ability to learn the exercise. Man Ther. 2009 Feb;14(1):13-8. doi: 10.1016/j.math.2007.07.008. Epub 2007 Oct 1.
- Derived from this study: PubMed 32148332Mena-Del Horno S, Balasch-Bernat M, Duenas L, Reis F, Louw A, Lluch E. Laterality judgement and tactile acuity in patients with frozen shoulder: A cross-sectional study. Musculoskelet Sci Pract. 2020 Jun;47:102136. doi: 10.1016/j.msksp.2020.102136. Epub 2020 Feb 24.
- Derived from this study: PubMed 31409380Lluch-Girbes E, Duenas L, Mena-Del Horno S, Luque-Suarez A, Navarro-Ledesma S, Louw A. A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial. Trials. 2019 Aug 13;20(1):498. doi: 10.1186/s13063-019-3585-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Lluch, PhD study director
Physiotherapy Department University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNS-focused treatment in people with Adhesive Capsulitis of Shoulder and Frozen Shoulder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain-related disability questionnaire (SPADI) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320200, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.