Overhead Perturbation Training for Glenohumeral Joint Instability

NCT03380494 | Unknown DMC

• 1 other identifier: 229780
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Movement Techniques; Shoulder Pain; Glenohumeral Subluxation

Keywords

Overhead perturbation training; instability, glenohumeral joint

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Secondary Outcomes (2)

• The Shoulder Instability-Return to Sport after Injury (SIRSI) score

  6 weeks

• Western Ontario Shoulder Instability Index (WOSI)

  6 weeks

Study Arms (2)

Overhead perturbation training technique

EXPERIMENTAL

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

Non-perturbed exercise

ACTIVE COMPARATOR

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

Interventions

Overhead perturbation training OTHER

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.

Also known as: OPT

Overhead perturbation training technique

Non-perturbed training OTHER

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.

Non-perturbed exercise

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE19RT, United Kingdom

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Dislocation

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Jennifer Boston

CONTACT

02071887188; R&D@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomised controlled trial

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 21, 2017
• Study Start: April 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)