Exercise Movement TechniquesOPTNCT03380494
Overhead Perturbation Training for Glenohumeral Joint Instability
A study testing Overhead perturbation training and Non-perturbed training in people with Exercise Movement Techniques and Shoulder Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Movement Techniques, Shoulder Pain, Glenohumeral Subluxation
- What is being tested?
- Overhead perturbation training and Non-perturbed training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2018to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas' NHS Foundation Trust
London, SE19RT
About this study
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
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.
Read the 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.
- Being tested
- Overhead perturbation training, Non-perturbed training
- Keywords
- Overhead perturbation training; instability, glenohumeral joint
- Medical subject headings
- Shoulder Pain, Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overhead perturbation trainingOther
Also called OPT
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.
Non-perturbed trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Non-perturbed training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (2)
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).
Measured: 6 weeks
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startApr 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Movement TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380494
- Sponsor's protocol ID
- 229780
- Other IDs
- 229780
- Acronym
- OPT
- Status last verified
- Feb 2018
- First submitted
- 8 Dec 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03380494
- Acronym / sponsor ID
- OPT / 229780
- Keywords
- Overhead perturbation training; instability, glenohumeral joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Overhead perturbation training technique | Experimental | Other: Overhead perturbation trainingPatients 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. |
| Non-perturbed exercise | Active comparator | Other: Non-perturbed trainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overhead perturbation trainingAlso: OPTA 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 | Overhead perturbation training technique |
| Non-perturbed trainingA 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. | Other | Non-perturbed exercise |
Primary outcome
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).
2 secondary outcomes
The Shoulder Instability-Return to Sport after Injury (SIRSI) score
Time frame: 6 weeks
Western Ontario Shoulder Instability Index (WOSI)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overhead perturbation training and Non-perturbed training in people with Exercise Movement Techniques and Shoulder Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Boston (02071887188 ext. 54426, R&D@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lazer-pointer assisted angle relocation test (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.