Progressive Resistance Training of the Biceps in Subacromial Impingement Syndrome

Shoulder Impingement Syndrome Clinical Trial

— PRTB  

Official title:

The Influence of Resistance Training Biceps as an Adjunct to Rehabilitation of the Shoulder in Subacromial Impingement Syndrome (SIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314196
• Other study ID #: UNCISAL/1019
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: March 11, 2011
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain at rest and quality of life	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.	initial time, 45 days and 90 days of treatment	No
Secondary	Evaluation range of motion,strength and physical symptoms of the shoulder	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.	initial time, 45 days and 90 days of treatment	No