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Shoulder Impingement SyndromeNCT02926443

Effectiveness of Supervised Motor Control Exercises on Rotator Cuff Tendinopathies

A study testing Upper Extremity Neuromuscular Training Program and Usual Physiotherapy Care in people with Shoulder Impingement Syndrome and Shoulder Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The shoulder is the most mobile joint in the body but still has the responsibility of ensuring a strong stability of our upper limbs during daily activities. The shoulder joint therefore requires a significant level of neuromuscular control at all times. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Upper Extremity Neuromuscular Training Program and Usual Physiotherapy Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteCanada
Study dates
Jan 2016to 31 Aug 2017
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Reported pain and / or stiffness to shoulder joint, localized tenderness over one of the rotator cuff muscles, reported night pain to the shoulder,
  • Painful arc of movement during flexion or abduction,
  • Positive Neer's Test or Kennedy-Hawkins Test,
  • Pain on resisted external (lateral) rotation, abduction or Empty Can Test,
  • A combined DASH-CF (Disability of the Arm, Shoulder, and Hand - Canadian French) score (all 3 subsections) greater than 15%, or a WORC-CF (Western Ontario Rotator Cuff Index - Canadian French) score greater than 12%,
  • Active military members.
  • N.B. The minimal scores for both the DASH and WORC questionnaires are based on their minimal clinically important difference (MCID). Also, the combination of criteria 2), 3) and 4) have a good diagnostic accuracy with sensitivity and specificity values ≥ 0.74. and Positive Likelihood Ratio = 3.5.

Who cannot join

  • Any prior history of shoulder surgery, dislocations, fractures, capsulitis,
  • Demonstrate any systematic pathologies (such as diabetes, neurological signs or symptoms, complex regional pain syndrome, rheumatoid conditions, or signs and symptoms of vascular compression or vestibular dysfunction),
  • Not able to commit to the treatment schedule of the project.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Valcartier Garrison, Physiotherapy Clinic

    Shannon, Quebec, G0A 4N1

Other trials in Canada

About this study

Official title: Effectiveness of the Upper Extremity Neuromuscular Training Program (UpEx-NTP) on Shoulder Function of People With Rotator Cuff Tendinopathies: A Pilot Randomized Control Trial

The shoulder is the most mobile joint in the body but still has the responsibility of ensuring a strong stability of our upper limbs during daily activities. The shoulder joint therefore requires a significant level of neuromuscular control at all times. The shoulder heavily relies on 4 key stabilizing muscles, known as the rotator cuff complex (RC). A tendinopathy of the RC may cause pain, significant muscle weakness, and a decrease in motor control of the shoulder during functional activities as well as work tasks. Individuals who have an RC tendinopathy often have neuromuscular and proprioceptive deficits. The objectives of this study are to evaluate the effectiveness of a brand new group strength and motor control exercise program for the upper extremities and to compare the effectiveness of this program to usual one-on-one physiotherapy care (such as manual therapy, motion exercises, strengthening, manual techniques) in reducing shoulder pain and improving overall function. A total of 33 participants suffering from an RC tendinopathy have been recruited; 16 have been assigned to the exercise group (EXP) and 17 participants have received usual physiotherapy care (CTL). Participants in the EXP group partook in the new exercise program 3 times / week for 6 weeks whereas participants in the CTL group received usual physiotherapy treatments twice / week with home exercises for 6 weeks. The results of this study will provide clinicians with a cost-effective and innovative treatment approach to treating shoulder pain. This study will provide active rehabilitation guidelines for reducing shoulder pain and the incidence of recurrence.

Read the detailed description

The importance of our shoulders to everyday movement and activity is often not fully appreciated, until we are limited by injury or pain. The shoulder complex allow us to interact with our surroundings while acting as the functional link between our stable trunks and our free moving upper limbs. This is no easy task for highly mobile joints such as the shoulders. A shoulder injury can be functionally devastating to an individual, and can potentially place unnecessary financial stress on our health care system. Shoulder pain is currently among the most common reasons to visit a general practitioner or a physiotherapist today. Shoulder pain is third in prevalence, only to back and neck pain, and nearly two-thirds of adults suffer from shoulder pain at some point during their lives. Despite being an important focus for rehabilitative care, we have yet to confidently establish efficient and potentially cost effective methods for treating shoulder pathologies and pain. Among shoulder disorders, the rotator cuff (RC) muscles are the leading source of shoulder pain. Due to the vast mobility of the shoulder complex, it relies greatly on the stability and control provided by its supportive tissues, notably the rotator cuff muscles; often rendering them highly susceptible to injury. It has been noted that individuals affected by rotator cuff tendinopathies (RCt) often exhibit motor control and shoulder proprioception deficits. As noted by Cools and colleagues, rehabilitative training programs that focus on motor control are greatly needed for rehabilitation as well as to prevent re-injury. Accordingly, rehabilitation interventions should focus on motor (re)learning, targeting a better muscle coordination to reduce motor control impairments, optimize movement control, and improve muscle strength.

Motor control rehabilitation: To address the motor control deficits among individuals affected by an RCt, we have developed a novel, structured, and supervised group exercise-based program focusing on neuromuscular reeducation. It is well documented in the scientific literature that motor control and proprioception exercises are crucial for healing among this population. However, the effectiveness of a group delivery method remains unknown. It is presently unclear how a group exercise program compares to one-on-one physiotherapy care for shoulder dysfunctions. The developed group program allows patients to individually progress their exercises based on their symptoms, while being guided and corrected by the supervising physiotherapist. This model allows several patients to access physiotherapy services simultaneously, while remaining cost and resource effective for the clinics. To appreciate the goal of the proposed exercise program, it is important to understand the physiological and biomechanical factors directly related to shoulder stability.

Underlying mechanisms for shoulder stability: For its joint stability, the glenohumeral (GH) joint heavily depends on muscle strength, adequate synergistic activity between the neuromuscular structures, as well as a strong joint position sense (a subcategory of proprioception). Our ability to detect our limbs in space helps us to interact with our surroundings and contributes to the neuromuscular stability of our joints. A RCt is often associated with a subacromial impingement syndrome, where structures under the acromion become pinched during arm elevation. Such a compression during arm movements can include abnormal shoulder kinematics, as well as RC and scapular muscles performance deficits. This inadequate scapulothoracic muscle control is believed to contribute to a reduction of amplitude in posterior tilting and lateral rotation of the scapula, which causes the acromion to remain in a lower anterolateral position resulting in a dynamic narrowing of the subacromial space. Also, the abnormal muscle control is associated with superior migration of humeral head with respect to the glenoid fossa, which again leads to a dynamic narrowing of the subacromial space. These deficits contribute to the impingement of subacromial structures and often lead to the symptoms associated with an RCt. What makes the investigated approach unique in addressing RC disorders is the resource-effective exercise rehabilitation model the investigators propose; a motor control and strengthening approach well supported in the scientific literature and packaged in a conveniently resource-friendly protocol. This approach maximizes patient autonomy while being matched to a suitable level of physiotherapist supervision. The investigators believe that the Upper Extremity Neuromuscular Training Program (UpEx-NTP) provides a realistic and financially beneficial solution to a costly health care problem.

Research Question: How will a 6-week UpEx-NTP improve shoulder function, pain, and joint position sense (JPS) in individuals affected by a rotator cuff (RC) tendinopathy compared to usual physiotherapy care? The primary objective of this randomized control trial (RTC) is to compare, in terms of symptoms and functional limitations, a group receiving a group-supervised rehabilitation program (UpEx-NTP) centered on strength and motor control training to a group receiving usual one-on-one physiotherapy clinical care in individuals affected by a RC tendinopathy of the shoulder. It is hypothesized that both the UpEx-NTP (Exp) and usual physiotherapy care (Ctl) groups will equally demonstrate statistically (p-value < 0.05) and clinically (all noted changes above their MCID : DASH questionnaire = 11 points, WORC index = 12 points and the Numeric Rating Scale for pain = 2 points) significant changes in shoulder function and pain over a 6-week period in individuals with an RC tendinopathy and will be maintained over time, notably 12-weeks after the intervention.

Being tested
Upper Extremity Neuromuscular Training Program, Usual Physiotherapy Care
Keywords
Shoulder, Motor control, Usual physiotherapy care, Supervised exercise program
Medical subject headings
Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper Extremity Neuromuscular Training ProgramOther

    Neuromuscular and strengthening shoulder exercises in a group setting.

  • Usual Physiotherapy CareOther

    One-on-one physiotherapy care in a clinical setting.

Study groups in NCT02926443
Study groupRoleWhat they receive
One-on-one Usual Physiotherapy Care (Control)Active comparatorThe Ctl group (n =16) will receive physiotherapy usual care treatments during a 6-week period. The Ctl group will receive 2 physiotherapy treatments (30 minutes) in the clinic per week (total of 12 treatments) as well as an individualized home exercise program (HEP). Treatments will include range of motion exercises, manual therapy treatments, modalities, and strengthening exercises, as determined by the treating physiotherapist. Specific muscle group exercises and parameters will be documented by the treating physiotherapist on a provided summary sheet.
Receives: Other: Usual Physiotherapy Care
Group Program (UpEx-NTP) (Exp)ExperimentalThe Exp group (n =16) will partake in a 6-week group Upper Extremity Neuromuscular Training Program that consists of postural education, strength exercises, motor control exercises, and upper extremity functional tasks common for active military personnel. The UpEx-NTP program consists of 35-45 minutes of exercise, three times a week for 6 weeks (18 treatments), supervised by a physiotherapist. The program consists of 11 stations with several variations of difficulty of the same exercise per station. The exercises of each station will be performed in order of difficulty. The participant chooses one exercise to perform per station based on their current ability while respecting their pain levels at 3/10 or less.
Receives: Other: Upper Extremity Neuromuscular Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in self-reported shoulder function at 6 weeks (DASH-CF)

    DASH-CF: Disability of Arm, Shoulder, and Hand Questionnaire (Canadian French). Self-reporting questionnaire that assesses the upper limb pain and disability of the participants. The DASH has 30-items over three sub-sections: General, Work, and Sports / Art. You can also interpret the global score (sum of the 3 sections). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score.

    Measured: Baseline to 6 weeks

Secondary outcomes (8)
  1. Change from baseline in self-reported shoulder function specific to rotator cuff disorders at 6 months (WORC-CF)

    WORC-CF: Western Ontario Rotator Cuff Index Questionnaire (Canadian French). A self-reporting, disease-specific quality of life questionnaire, that will evaluate the change in symptoms of our participants specific to their rotator cuff disorder.

    Measured: Baseline to 6 weeks

  2. Change from baseline in self-reported shoulder function specific to rotator cuff disorders at 6 weeks (WORC-CF)

    WORC-CF: Western Ontario Rotator Cuff Index Questionnaire (Canadian French). A self-reporting, disease-specific quality of life questionnaire, that will evaluate the change in symptoms of our participants specific to their rotator cuff disorder.

    Measured: Baseline to 12 weeks

  3. Change from baseline in shoulder strength at 6 weeks

    Bilateral shoulder strength will be assessed using a hand held dynamometer (HHD) by the evaluator for shoulder abductors and external rotator muscles.

    Measured: Baseline to 6 weeks

  4. Change from baseline in level of perceived shoulder pain at 6 weeks (NPRS)

    Pain levels will be assessed at 6 weeks using the 11-point Numeric Rating Scale (NRS) for pain, where 0 represents "no pain" and 10 represents "worst pain imaginable".

    Measured: Baseline to 6 weeks

  5. Change from baseline in common military task

    Repeated sand bag lift (20kg, 30 repetitions in 3 minutes 30 seconds)

    Measured: Baseline to 6 weeks

  6. Change from baseline of perceived level of change in symptoms

    Global Rating of Change (GROC) questionnaire

    Measured: Baseline to 6 weeks

  7. Change from baseline of perceived level of change in symptoms

    Global Rating of Change (GROC) questionnaire

    Measured: Baseline to 12 weeks

  8. Change from baseline in self-reported shoulder function at 12 weeks (DASH-CF)

    DASH-CF: Disability of Arm, Shoulder, and Hand Questionnaire (Canadian French). Self-reporting questionnaire that assesses the upper limb pain and disability of the participants.

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion31 Aug 2017
  4. Study completion31 Aug 2017

Resources

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
Masking
Single blind
Who is masked
Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926443
Sponsor's protocol ID
2015-446
Status last verified
Aug 2018
First submitted
18 Jul 2016
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ager AL, Roy JS, Gamache F, Hebert LJ. The Effectiveness of an Upper Extremity Neuromuscular Training Program on the Shoulder Function of Military Members With a Rotator Cuff Tendinopathy: A Pilot Randomized Controlled Trial. Mil Med. 2019 May 1;184(5-6):e385-e393. doi: 10.1093/milmed/usy294.

    PubMed 30423137

Questions about this trial

What is this clinical trial studying?

A study testing Upper Extremity Neuromuscular Training Program and Usual Physiotherapy Care in people with Shoulder Impingement Syndrome and Shoulder Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 22 Aug 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in self-reported shoulder function at 6 weeks (DASH-CF) (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926443, which also lists 1 linked publication.

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 22 Aug 2018.

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