Shoulder Pain Clinical Trial
— OPTOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | August 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guys and St Thomas' NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | 6 weeks | |
Secondary | 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). |
6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04930393 -
Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
|
N/A | |
Completed |
NCT03717753 -
Rotator Cuff Pathway
|
N/A | |
Completed |
NCT04454671 -
Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment
|
N/A | |
Completed |
NCT06274827 -
Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises
|
N/A | |
Not yet recruiting |
NCT05413213 -
Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder
|
N/A | |
Not yet recruiting |
NCT05043844 -
Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder
|
N/A | |
Recruiting |
NCT02903719 -
The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.
|
Phase 4 | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Completed |
NCT02554968 -
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
|
||
Recruiting |
NCT02242630 -
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Completed |
NCT02631395 -
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
|
N/A | |
Completed |
NCT01885377 -
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
|
N/A | |
Completed |
NCT01733914 -
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
|
Phase 2 | |
Completed |
NCT01205542 -
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
|
N/A | |
Completed |
NCT01843660 -
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
|
Phase 4 | |
Completed |
NCT00743600 -
Ultrasound Evaluation of the Rotator Cable and Associated Structures.
|
N/A | |
Completed |
NCT00679887 -
Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
|
Phase 1/Phase 2 | |
Completed |
NCT04058522 -
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
|
N/A | |
Completed |
NCT03353272 -
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
|
N/A |