Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

NCT00633451 | Completed

• 1 other identifier: 07-173
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder pain; shoulder impingement syndrome; manual therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Shoulder disability and pain

  6 weeks and 3, 6,12 months

Secondary Outcomes (2)

• Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication

  6 weeks, and 3, 6, 12 months

• Patient perceived global rating of effect

  6 weeks and 3 months

Study Arms (2)

1

EXPERIMENTAL

Manual Therapy + Exercise

Other: Manual Therapy and Exercise

2

ACTIVE COMPARATOR

Exercise Only

Other: Exercise Only

Interventions

Manual Therapy and Exercise OTHER

Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.

Also known as: Manual Therapy and Therapeutic Exercise

1

Exercise Only OTHER

A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function

Also known as: Therapeutic Exercise

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms associated with athletic activity (35% of patients)
• Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:
• Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test
• Pain during active shoulder elevation at or above 60 degrees
• Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
• Shoulder disability: 25/100 (0 = no disability)
• Able to understand written and spoken

You may not qualify if:

• Severe pain; pain is \> 7/10 on NPRS (0 = no pain)
• Shoulder surgery on affected shoulder
• Traumatic shoulder dislocation within the past 3 months
• Previous rehabilitation for this episode of shoulder pain
• Reproduction of shoulder pain with active or passive cervical motion
• Systemic inflammatory joint disease
• Global loss of passive shoulder ROM, indicative of adhesive capsulitis
• Full-thickness rotator cuff tear, as evidenced by any one of the following:
• Markedly reduced shoulder external rotation strength
• Drop arm test
• External rotation lag sign
• Lift off test
• Positive findings on MRI or ultrasonography

Sponsors & Collaborators

• Proaxis Therapy: lead
• Virginia Commonwealth University: collaborator
• Arcadia University: collaborator
• National Athletic Trainers' Association Research & Education Foundation (NATA Foundation): collaborator

Study Sites (1)

Proaxis Therapy

Greenville, South Carolina, 29607, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Musculoskeletal Manipulations; Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Charles A Thigpen, PhD, PT, ATC

  University of North Florida

  PRINCIPAL INVESTIGATOR

• Lori A Michener, PhD, PT, ATC

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Phil McClure, PhD, PT

  Arcadia University

  PRINCIPAL INVESTIGATOR

• Angela R Tate, PhD, PT

  Arcadia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Scientist

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

US (1)