A Central Nervous System Focused Treatment Approach for Frozen Shoulder

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of Shoulder; Frozen Shoulder
• Intervention / Treatment: Other: CNS-focused treatment; Other: Standard Care Treatment

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: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Conventional physiotherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Baseline
Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Change from baseline ROM at 10 weeks
Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	Change from baseline ROM at 3 months
Goniometric assessment of active shoulder ROM (range of motion)	Degrees of active range of motion	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	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	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	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	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	Baseline
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Valencia

Publications and helpful links

General 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.
• 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 May 5.
• Moseley 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.
• 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.
• Moseley 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.
• 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. doi: 10.1016/j.math.2007.07.008. Epub 2007 Oct 1.
• Mena-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.
• Lluch-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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 9, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: H1507114540624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No