Effectiveness of Supervised Motor Control Exercises on Rotator Cuff Tendinopathies

NCT02926443 | Completed DMC

• 1 other identifier: 2015-446
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shoulder Impingement Syndrome; Shoulder Rotator Cuff Tendinopathy

Keywords

Shoulder; Motor control; Usual physiotherapy care; Supervised exercise program

Outcome Measures

Primary Outcomes (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.

  Baseline to 6 weeks

Secondary Outcomes (8)

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

  Baseline to 6 weeks

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

  Baseline to 12 weeks

• Change from baseline in shoulder strength at 6 weeks

  Baseline to 6 weeks

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

  Baseline to 6 weeks

• Change from baseline in common military task

  Baseline to 6 weeks

Study Arms (2)

One-on-one Usual Physiotherapy Care (Control)

ACTIVE COMPARATOR

The 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.

Other: Usual Physiotherapy Care

Group Program (UpEx-NTP) (Exp)

EXPERIMENTAL

The 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.

Other: Upper Extremity Neuromuscular Training Program

Interventions

Upper Extremity Neuromuscular Training Program OTHER

Neuromuscular and strengthening shoulder exercises in a group setting.

Group Program (UpEx-NTP) (Exp)

Usual Physiotherapy Care OTHER

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

One-on-one Usual Physiotherapy Care (Control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• CIRRIS (Center for Interdisciplinary Research in Rehabilitation and Social Integration): collaborator
• OPPQ (Ordre Professionnel de la Physiothérapie du Québec): collaborator
• REPAR (Réseau Provincial de Recherche en Adaptation-Réadaptation): collaborator

Study Sites (1)

Valcartier Garrison, Physiotherapy Clinic

Shannon, Quebec, G0A 4N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 30423137 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Luc J. Hébert, MSc PT, PhD

  CIRRIS / IRDPQ, Canadian Armed Forces (CAF)

  STUDY DIRECTOR

• Jean-Sébastien Roy, MSc PT, PhD

  IRDPQ and CIRRIS

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)