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Completed

NCT Number: NCT00826293

The Clinical Efficacy of Belting Stabilization for Shoulder Pain

Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.

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Key information

Conditions

Rotator Cuff Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Holland Orthopaedic and Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

About this study

Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic & Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm

Exclusion criteria

  • Inability to speak or read English
  • Evidence of major joint trauma causing fracture
  • Infection
  • Underlying metabolic or inflammatory disease
  • Avascular necrosis
  • Frozen shoulder
  • Major medical illness
  • Psychiatric illness that precluded informed consent

Treatment and study plan

Stabilization belt

Procedure

Patients receive true stabilization.

Other names: Belt Stabilization

Primary outcomes

  1. The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH)

    Time frame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment

Secondary outcomes

  1. The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25).

    Time frame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 22, 2009
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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