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Overhead Perturbation Training for Glenohumeral Joint Instability (OPT)

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ClinicalTrials.gov Identifier: NCT03380494
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Exercise Movement Techniques Shoulder Pain Glenohumeral Subluxation Other: Overhead perturbation training Other: Non-perturbed training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomised controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Overhead perturbation training technique
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.
Other: Overhead perturbation training
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.
Other Name: OPT

Active Comparator: Non-perturbed exercise
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.
Other: Non-perturbed training
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 Measures :
  1. Lazer-pointer assisted angle relocation test [ Time Frame: 6 weeks ]
    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 :
  1. The Shoulder Instability‑Return to Sport after Injury (SIRSI) score [ Time Frame: 6 weeks ]
    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).

  2. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 6 weeks ]

    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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380494


Contacts
Contact: Jennifer Boston 02071887188 ext 54426 R&D@gstt.nhs.uk

Locations
United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom, SE19RT
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03380494     History of Changes
Other Study ID Numbers: 229780
229780 ( Registry Identifier: IRAS )
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Overhead perturbation training; instability, glenohumeral joint

Additional relevant MeSH terms:
Shoulder Dislocation
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Dislocations
Bone Diseases
Wounds and Injuries
Shoulder Injuries