Progressive Resistance Training of the Biceps in Subacromial Impingement Syndrome (PRTB)

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01314196
First received: March 9, 2011
Last updated: March 11, 2011
Last verified: December 2010
  Purpose

The aim of this study was to evaluate the influence of progressive resistance training of the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS).

Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the presence of pain exacerbated, every eight hours. Study groups will perform therapeutic exercises for the shoulder and scapula stabilizers. In the experimental group associate progressive resistance training of the biceps.


Condition Intervention
Shoulder Impingement Syndrome
Other: therapeutic exercises
Other: biceps resistance training and therapeutic exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Resistance Training Biceps as an Adjunct to Rehabilitation of the Shoulder in Subacromial Impingement Syndrome (SIS)

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Evaluation of pain at rest and quality of life [ Time Frame: initial time, 45 days and 90 days of treatment ] [ Designated as safety issue: No ]
    Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (unbearable pain). The Westein Ontario Rotator Cuff Index (WORC) and Short form-36(SF-36) were the instruments used to assess the quality of life.


Secondary Outcome Measures:
  • Evaluation range of motion,strength and physical symptoms of the shoulder [ Time Frame: initial time, 45 days and 90 days of treatment ] [ Designated as safety issue: No ]
    The range of motion the shoulder will be assessed by goniometry for flexion, extension, medial and lateral rotation and abduction. The strength of manual pressure was assessed using the hydraulic dynamometer, Jamar type, manufactured by Saehan Corporation in Korea. O Disabilities Of The Arm, Shoulder and Hand (DASH), was intended for assessment of physical symptoms and disorders of the upper limbs.


Enrollment: 60
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: therapeutic exercises
therapeutic exercises for the shoulder and scapula stabilizers
Other: therapeutic exercises
therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without producing subacromial impaction.
Other Name: therapeutic exercises
Experimental: progressive resistance training biceps
therapeutic exercises for the shoulder and scapula stabilizers and biceps resistance training.
Other: biceps resistance training and therapeutic exercises
The biceps resistance training based on calculations of maximum resistance (MR), being conduct in three series 10 reps with 50% of MR in the first series of training and 75% of MR in the second series, with 2 minutes between each and therapeutic exercises for the shoulder and scapula stabilizers.
Other Name: progressive resistance training

Detailed Description:

Sixty patients in the Physical Therapy Clinic at the University of Health Sciences of Alagoas, of both sexes with a clinical diagnosis of SIS, according to the criteria of Neer. Included will be those with a diagnosis of injury to one or more rotator cuff tendons, with pain for three months or more, ranging from 3 to 8, based on visual analogic scale(VAS) ranging from 0 to 10. Hawkins' test and Neer positive and aged between 18 and 65. The presence of total rupture of the long head of biceps, and associated rheumatic shoulder surgery represented exclusion criteria. After approval by the IRB (1019/08) were prepared sealed envelopes, to maintain the secrecy of allocation, and the patients were divided into control and experimental group and evaluated by a blind assessor, at the initial time (T0), after 45 days of treatment (T45) and 90 days of treatment (T90). The shoulder will be assessed in the degree of active motion for flexion, extension, medial and lateral rotation and abduction, with the patient in standing position using manual goniometer. To determine the movement of flexion and extension, the upper limb was positioned in the sagittal plane, goniometer along the mid-axillary line of the trunk and the axle in the humeral head. The movable arm of the goniometer was placed over the body surface of the humerus toward the lateral epicondyle. Abduction to the fixed arm of the goniometer was positioned over the posterior axillary line of the trunk, aligned with the blade and the moving arm was placed on the posterior surface of the arm along the longitudinal axis of the humerus. The medial and lateral rotation was accomplished by positioning the shoulder in abduction of 90 degrees, the axle of the goniometer positioned on the olecranon and the movable arm along the axis of the forearm.

The strength of manual pressure was assessed using the hydraulic dynamometer, manufactured in Korea. The instrument is graduated in two scales - kilogram force (Maximum 90 pounds), form-fitting and catcher with five adjustment positions to accommodate any size hand during the evaluation. During the strength assessment, the upper limb was positioned at rest beside the body with elbow flexed 90 degrees, forearm and wrist in neutral position.

Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (intolerable pain). The Disabilities of The Arm, Shoulder and Hand (DASH) questionnaire was used for the evaluation of impairment and physical symptoms of upper limbs. It consists of 30 mandatory items related to function and symptoms (DASH 1) and two optional areas, divided into four issues for work activities (DASH 2) and 4 questions for activities of daily living (DASH 3). The Western Ontario Rotator Cuff Index (WORC) and Short- form health survey (SF-36) were the tools used to evaluate the quality of life. The WORC is specific to patients suffering from rotator cuff injury with five domains: physical symptoms (SF), sports and recreation (ER), work (T), state of vitality (EV) and emotion (E). The WORC scores can be set by calculation or by the general analysis of independent domains.

The treatment plan will be held for 3 months, twice a week throughout the sample, through the practice of therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without subacromial generate impaction. In the experimental group, we associate the progressive resistance training of the biceps. The progression of resistance training biceps, based on calculations of maximum resistance (MR), being conducted in three sets of 10 repetitions with 50% of MRI in the first series of training and 75% of MRI in the second series, 2 minutes, between each. In the presence of pain greater than or equal to seven, based on the VAS, patients were instructed in the use of paracetamol 750mg every six hours and diclofenac sodium 50mg every eight hours.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a clinical diagnosis of injury to one or more muscles of the rotator cuff;
  • pain for three months or more, and pain between three and eight, according to visual analog scale (VAS);
  • Hawkins and Neer test positive;
  • aged between 18 and 65

Exclusion Criteria:

  • fractures of the upper phase of consolidation;
  • patients with total rupture of the long head of the biceps due to the impossibility of getting the muscle resistance training;
  • patients undergoing surgical procedures for shoulder in the three months preceding the study;
  • associated rheumatic diseases because they may interfere in the evaluation of patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314196

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 05360-160
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: ANA C COÊLHO Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Jamil Natour, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01314196     History of Changes
Other Study ID Numbers: UNCISAL/1019
Study First Received: March 9, 2011
Last Updated: March 11, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
biceps
resistance training
rehabilitation
impact syndrome

Additional relevant MeSH terms:
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014