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Overhead Perturbation Training for Glenohumeral Joint Instability (OPT)

Primary Purpose

Exercise Movement Techniques, Shoulder Pain, Glenohumeral Subluxation

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Overhead perturbation training
Non-perturbed training
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Movement Techniques focused on measuring Overhead perturbation training; instability, glenohumeral joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A clinical presentation indicative of glenohumeral joint functional instability as classified by the Stanmore classification of shoulder instability Polar type II-III (on a continuum between atraumatic structural instability and non-structural, muscle patterning instability (Jaggi and Lambert, 2010)).

-

Exclusion Criteria:

  • Presence of:
  • Connective tissue disorder (Marfan's, Ehlos-Danlos)
  • Nerve disorders: cervical radiculopathy +/- myotomal weakness; peripheral neuropathy/ palsy (long thoracic nerve palsy, axillary nerve palsy, suprascapular nerve palsy, etc.); brachial neuritis.
  • Neuropathic peripheral sensitivity and/ or central sensitisation
  • Post operative orthopaedic intervention < 12 weeks post MRI confirmed full thickness rotator cuff tear
  • Distal upper limb/ hand pathology which limits the ability to grasp (including specific pathological signs of lateral epicondylaglia, carpal tunnel syndrome, carpal instability, etc).
  • - inability to follow instructions

Sites / Locations

  • Guys and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Overhead perturbation training technique

Non-perturbed exercise

Arm Description

Patients will undertake a series of exercise positions with the arm elevated above shoulder level with a stimulus applied with a weight and resistance band- such that the glenohumeral joint is exposed to a perturbed stimulus and has to utilise proprioception and motor control to correct arm position. The exercise session will be 45mins in length and occur once per week for 6 weeks.

Patients will undertake a series of exercise positions with the arm elevated above shoulder level with a stimulus applied via a weight held in the hand- such that the glenohumeral joint is exposed to a load but without a perturbation of joint position. The exercise session will be 45mins in length and occur once per week for 6 weeks.

Outcomes

Primary Outcome Measures

Lazer-pointer assisted angle relocation test
The laser pointer assisted angle-reproduction test (LP- ART) is a more simple and clinically friendly assessment tool. The outcome measure involves the patient pointing a wrist-mounted laser at 3 different targets (55', 90' and 125') in both the coronal and sagittal plane, with average of 3 being used. This method and has been shown to effectively quantify proprioceptive dysfunction in patients with shoulder instability (Balke, 2011).

Secondary Outcome Measures

The Shoulder Instability-Return to Sport after Injury (SIRSI) score
The Shoulder Instability-Return to Sport after Injury (SIRSI) score has been developed and proposed as an easy to use score for evaluating an athlete's ability to return to sport. The score is validated and reliable in the use as an outcome measure for shoulder anterior instability patients (Gerometta et al. 2017).
Western Ontario Shoulder Instability Index (WOSI)
The tool is a patient completed, questionnaire consisting of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (best possible score - the patient is experiencing no decrease in shoulder-related quality of life) to 2100 (worst score - signifies extreme distress in shoulder-related quality of life). The WOSI is a valid, reliable and sensitive assessment for patients with shoulder problems that are associated with instability and it's widely recommended for use in the evaluation of these patients (Kirkley et al, 1998).

Full Information

First Posted
December 8, 2017
Last Updated
February 19, 2018
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03380494
Brief Title
Overhead Perturbation Training for Glenohumeral Joint Instability
Acronym
OPT
Official Title
The Effectiveness of Overhead Perturbation Training on Joint Position Sense in Patients With Functional Shoulder Instability: A Pilot Study With Blinded, Randomized Controlled Trial Design
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the trial is investigate the benefits of a novel, newly invented exercise technique protocol relative to physiological changes in upper limb proprioception (primary) and subjective readiness for return to sport (secondary). The intervention (Overhead perturbation training) will be compared with a control intervention (non-perturbed stimulus) in a population of type II anterior glenohumeral joint instability patients (according to the Stanmore classification of instability). Each group will be assessed at baseline for glenohumeral joint proprioception (via lazer-pointer active relocation test), as well as perceived functional level (via Western Ontario Shoulder Instability index) and Shoulder Instability-Return to Sport after Injury (SIRSI) score. They will then undertake a 6 week exercise regime which is exactly the same- except the intervention used perturbated stimulus and the control uses non-perturbed stimulus. Outcome measures are re-assessed at the end of the intervention period. Results will be assessed statistically for statistical significance.
Detailed Description
Overhead athletic performance requires both static and dynamic mechanisms to coordinate glenohumeral and scapulothoracic stability to induce the appropriate motor response. Active function is predicated on a sufficient balance of muscular strength, endurance, flexibility and neuromuscular response to proprioceptive input. Coordinating, planning and synthesising complex multi-joint information is a process within the central nervous system, from the periphery to the higher centres of the brain, in a synergy of afferent and efferent feedback. Joint position sense plays an important role for the shoulder joint in two key components of athletic performance: conscious limb placement and unconscious motor patterning in response to external force during movement. Such motor patterns can be characterised as the motor responsiveness to perturbations of joint position. This assists efficiency of muscular coordination when the shoulder is placed in the long lever position during overhead activities, where the desired motor pattern reaction is essential alongside contractile strength for successful performance and attenuation of injury risk. It is suggested that efficiency in neuromuscular control to provide responsive stabilization is necessary to sustain high levels of overhead performance and to avoid injury. The neuromuscular control response of the shoulder musculature on glenohumeral and scapulothoracic joint positions becomes deficient in the presence of structural injury. For example, rotator cuff injury specifically leads to deficiencies in neuromuscular control timing, patterning and strength compared with asymptomatic clients. Perturbation of upper limb position during overhead activities causes unpredicted change in tissue length, resulting in a responsive pattern of muscular contractions. The OPT exercise series ensures that the deficient client is exposed to positions of vulnerability against displacement of the limb by external force. It is postulated that neural adaptations are induced through introduction of both rhythmic and sudden alterations to these positions A training stimulus (such as OPT) which facilitates neuromuscular control and speed of response to perturbation has potential to enhance overhead function. This signifies the role of neuromuscular control training in both rehabilitation and prevention of shoulder joint injury. The inclusion of this type of exercise training during rehabilitation and as part of injury risk minimisation strategies is an important component to sustain synchronization of muscular movement patterns. Population in Focus The subjects recruited for this study will be explained in greater depth further in the proposal, however are characterised by having a degree of functional glenohumeral joint instability. The physiotherapy class setting which will be utilised as the source of referrals is a heterogenous group of upper limb disorder patients, with a distinct sub group of individuals with functional instability who achieve sufficient recovery to meet the criteria for return to sport. According to the Stanmore classification of shoulder instability this group would correspond to Polar type II-III- that is placed on a continuum between atraumatic structural instability and non-structural, muscle patterning instability. Current treatment versus OPT The optimal management of anterior shoulder instability in those who undertake sport continues to be a challenge. Exercise therapy rehabilitation in a structured protocol shows statistically significant changes in validated outcome measures (Oxford Instability Shoulder Scores and Western Ontario Shoulder Index scores) but fails to incorporate exercise at the point of most instability through range of motion, particularly with sufficient challenge to the neuromuscular system to promote adaptation against perturbation at this point. Of course OPT is not suggested to replace traditional measures of exercise therapy, but instead is designed to complement and optimise rehabilitation. By influencing both the physical and psychometric obstructions to return to activity, the OPT aims to improve patient care and enhance quality of life in its users. This has the additional benefit of streamlining the care pathway of this patient population, and in preparing them to return to higher levels of function, will potentially reduce recurrence of future injury. The pathway for these patients is optimised and made more efficient by providing the same amount of therapist contact, in a class setting to incorporate multiple users at once, but should enhance post intervention clinical scores. The application of similar programmes as a component of rehabilitation is already considered elsewhere; however the specific nature of OPT is suggested to enhance even these currently used protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Movement Techniques, Shoulder Pain, Glenohumeral Subluxation
Keywords
Overhead perturbation training; instability, glenohumeral joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, randomised controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overhead perturbation training technique
Arm Type
Experimental
Arm Description
Patients will undertake a series of exercise positions with the arm elevated above shoulder level with a stimulus applied with a weight and resistance band- such that the glenohumeral joint is exposed to a perturbed stimulus and has to utilise proprioception and motor control to correct arm position. The exercise session will be 45mins in length and occur once per week for 6 weeks.
Arm Title
Non-perturbed exercise
Arm Type
Active Comparator
Arm Description
Patients will undertake a series of exercise positions with the arm elevated above shoulder level with a stimulus applied via a weight held in the hand- such that the glenohumeral joint is exposed to a load but without a perturbation of joint position. The exercise session will be 45mins in length and occur once per week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Overhead perturbation training
Other Intervention Name(s)
OPT
Intervention Description
A specifically chosen weight is attached to a 1m resistance band held above the head, hanging against gravity. The participant is encouraged to sustain a static position, where the weight and band provide variable magnitude perturbations to arm position. The body position of the participant is modified to facilitate greater and lesser perturbations. Bodily movements are prescribed to encourage joint perturbation. The participant undertakes 3 sets of 25 repetitions (60s rest) and continues with variable stimulus until fatigued.
Intervention Type
Other
Intervention Name(s)
Non-perturbed training
Intervention Description
A weight is grasped by the participant and elevated above head to the same position as the OPT intervention. The participant is encouraged to sustain a static position. The body position of the participant is modified to facilitate greater and lesser perturbations. Bodily movements are prescribed to encourage joint perturbation. The participant undertakes 3 sets of 25 repetitions (60s rest) and continues with variable stimulus until fatigued.
Primary Outcome Measure Information:
Title
Lazer-pointer assisted angle relocation test
Description
The laser pointer assisted angle-reproduction test (LP- ART) is a more simple and clinically friendly assessment tool. The outcome measure involves the patient pointing a wrist-mounted laser at 3 different targets (55', 90' and 125') in both the coronal and sagittal plane, with average of 3 being used. This method and has been shown to effectively quantify proprioceptive dysfunction in patients with shoulder instability (Balke, 2011).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Shoulder Instability-Return to Sport after Injury (SIRSI) score
Description
The Shoulder Instability-Return to Sport after Injury (SIRSI) score has been developed and proposed as an easy to use score for evaluating an athlete's ability to return to sport. The score is validated and reliable in the use as an outcome measure for shoulder anterior instability patients (Gerometta et al. 2017).
Time Frame
6 weeks
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
The tool is a patient completed, questionnaire consisting of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (best possible score - the patient is experiencing no decrease in shoulder-related quality of life) to 2100 (worst score - signifies extreme distress in shoulder-related quality of life). The WOSI is a valid, reliable and sensitive assessment for patients with shoulder problems that are associated with instability and it's widely recommended for use in the evaluation of these patients (Kirkley et al, 1998).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical presentation indicative of glenohumeral joint functional instability as classified by the Stanmore classification of shoulder instability Polar type II-III (on a continuum between atraumatic structural instability and non-structural, muscle patterning instability (Jaggi and Lambert, 2010)). - Exclusion Criteria: Presence of: Connective tissue disorder (Marfan's, Ehlos-Danlos) Nerve disorders: cervical radiculopathy +/- myotomal weakness; peripheral neuropathy/ palsy (long thoracic nerve palsy, axillary nerve palsy, suprascapular nerve palsy, etc.); brachial neuritis. Neuropathic peripheral sensitivity and/ or central sensitisation Post operative orthopaedic intervention < 12 weeks post MRI confirmed full thickness rotator cuff tear Distal upper limb/ hand pathology which limits the ability to grasp (including specific pathological signs of lateral epicondylaglia, carpal tunnel syndrome, carpal instability, etc). - inability to follow instructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Boston
Phone
02071887188
Ext
54426
Email
R&D@gstt.nhs.uk
Facility Information:
Facility Name
Guys and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.

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Overhead Perturbation Training for Glenohumeral Joint Instability

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