A Central Nervous System Focused Treatment Approach for Frozen Shoulder

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320200
• Other study ID #: H1507114540624
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 18, 2021

Study information

• Verified date: July 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis
• Frozen Shoulder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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: — View Citation

Louw 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. Review. — View Citation

Louw 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 — View Citation

Moseley G, Butler D, Beames T, Giles T. The graded motor imagery handbook. Adelaide: Noigroup Publishing; 2012.

Moseley GL. Do training diaries affect and reflect adherence to home programs? Arthritis Rheum. 2006 Aug 15;55(4):662-4. — View Citation

Mottram 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. Epub 2007 Oct 1. — View Citation

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Change from baseline SPADI at 10 weeks
Primary	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.	Change from baseline SPADI at 3 months
Primary	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.	Change from baseline SPADI at 6 months
Secondary	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").	Baseline
Secondary	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").	Change from baseline Numeric Rating Pain Scale at 10 weeks
Secondary	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").	Change from baseline Numeric Rating Pain Scale at 3 months
Secondary	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").	Change from baseline Numeric Rating Pain Scale at 6 months
Secondary	Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Baseline
Secondary	Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Change from baseline ROM at 10 weeks
Secondary	Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Change from baseline ROM at 3 months
Secondary	Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Change from baseline ROM at 6 months
Secondary	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	Baseline
Secondary	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	Change from baseline two point discrimination threshold at 10 weeks
Secondary	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	Change from baseline two point discrimination threshold at 3 months
Secondary	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	Change from baseline two point discrimination threshold at 6 months
Secondary	Laterality judgement accuracy	Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol	Baseline
Secondary	Laterality judgement accuracy	Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol	Change from baseline laterality judgement accuracy at 10 weeks
Secondary	Laterality judgement accuracy	Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol	Change from baseline laterality judgement accuracy at 3 months
Secondary	Laterality judgement accuracy	Laterality judgement accuracy using the NOI Recognise online program (www.noigroup.com) and following and established protocol	Change from baseline laterality judgement accuracy at 6 months
Secondary	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.	Baseline
Secondary	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.	Change from baseline Tampa Scale of Kinesophobia at 10 weeks
Secondary	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.	Change from baseline Tampa Scale of Kinesophobia at 3 months
Secondary	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.	Change from baseline Tampa Scale of Kinesophobia at 6 months
Secondary	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.	Baseline
Secondary	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.	Change from baseline Patient Specific Functional Scale at 10 weeks
Secondary	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.	Change from baseline Patient Specific Functional Scale at 3 months
Secondary	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.	Change from baseline Patient Specific Functional Scale at 6 months