A Central Nervous System Focused Treatment Approach for Frozen Shoulder

NCT03320200 | Completed

• 1 other identifier: H1507114540624
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of Shoulder; Frozen Shoulder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• Numeric Pain Rating Scale

  Baseline

• Numeric Pain Rating Scale

  Change from baseline Numeric Rating Pain Scale at 10 weeks

• Numeric Pain Rating Scale

  Change from baseline Numeric Rating Pain Scale at 3 months

• Numeric Pain Rating Scale

  Change from baseline Numeric Rating Pain Scale at 6 months

• Goniometric assessment of active shoulder ROM (range of motion)

  Baseline

Study Arms (2)

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

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

Other: Standard Care Treatment

Interventions

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.

Also known as: graded motor and sensory imagery traininng

CNS-focused treatment

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.

Also known as: Conventional physiotherapy treatment

Standard Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (9)

• 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.

  PMID: 21350034 RESULT

• 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.

  PMID: 28483657 RESULT

• 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.

  PMID: 16874790 RESULT

• 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.

  PMID: 22133255 RESULT

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

  RESULT

• 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.

  PMID: 28715302 RESULT

• 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.

  PMID: 17910930 RESULT

• 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.

  PMID: 32148332 DERIVED

• 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.

  PMID: 31409380 DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Enrique Lluch, PhD

  Physiotherapy Department University of Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 25, 2017
• Study Start: October 1, 2017
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

ES (1)