Changes in Subjects With Posterior Capsule Tightness

Shoulder Pain Clinical Trial

Official title:

Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02353442
• Other study ID #: 860.648
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: January 18, 2015
• Last updated: April 7, 2016
• Start date: March 2015
• Est. completion date: January 2018

Study information

• Verified date: April 2016
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To identify biomechanical and sensibility changes in people with posterior capsule tightness in people with and without shoulder pain.

Description:

Some studies have shown that posterior capsule tightness can be related with shoulder dysfunctions and kinematics alterations. This study will be divided in two studies. The purpose of study 1 will be to assess the scapular and humeral kinematics, the strength of the shoulder external rotators and the pressure pain threshold in subjects with posterior capsule tightness with and without shoulder pain. Study 2 will verify the effects of two different treatments in subjects with posterior capsule tightness and shoulder pain on the same variables of study 1. One-hundred subjects will participate in the first study and will be divided in 4 groups: Group 1 - 25 subjects with shoulder pain and posterior capsule tightness; Group 2 - 25 subjects with no shoulder pain and no posterior capsule tightness; Group 3 - 25 subjects with shoulder pain and no posterior capsule tightness; and group 4 - 25 subjects with no shoulder pain and no posterior capsule tightness. All subjects will complete the DASH and Shoulder Pain and Disability Index questionnaires. External and internal rotation range of motion, strength of the external rotators, scapular kinematics and humeral translations during arm elevation, and pressure pain threshold will be measured. For the second study 50 subjects with shoulder pain and posterior capsule tightness will be recruited. The subjects will be randomly divided in 2 groups: experimental group or control group. The experimental group will receive glenohumeral posterior mobilization, stretching of posterior capsule and strengthening of the shoulder external rotators. The control group will do ultrasound;, stretching for the upper trapezius and scapular squeezing. Both groups will receive intervention for 3x/week/4 weeks. All subjects will be supervised for one physiotherapist and same variables from study 1 will be analyzed at pre and post-intervention.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria: all subjects should have posterior capsule tightness and shoulder pain. So they should have:

• low flexion test (flexion + internal rotation) > 7°, between arms;

• symptoms consistent to shoulder impingement and arm elevation close to 150° as determined by digital inclinometer. The diagnosis for SIS was made based on a clinical examination and self-reported history. To be classified as having shoulder impingement, subjects had to present with at least 3 of the following: positive Neer test, positive Hawkins test, positive Jobe test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation, and pain in the anterolateral shoulder region.

Exclusion Criteria: Individuals from both groups were excluded if they:

• were pregnant;

• had ligamentous laxity based on positive Sulcus test, Apprehension test or anterior drawer;

• had history of clavicle, scapula or humerus fracture;

• history of shoulder surgery or traumatic lesion; -had adhesive capsulitis or scoliosis; - had systemic illnesses;

• transpore tape allergy;

• body mass index > 28kg/m2;

• physical therapy treatment in the last 6 months;

• bilateral symptoms;

• steroid injection in the last 6 weeks;

• drugs with muscle relaxant in the last 72 hours.

Study Design

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Posterior shoulder mobilizations
The subjects will be randomized to Experimental or control group.

Locations

Country	Name	City	State
Brazil	UFSCar	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in scapular and humeral kinematic	Both will be assess in degrees with 3D system.	4 weeks	Yes
Secondary	Changes in the strength of the shoulder external rotators	The strength will be evaluated with digital dynamometer in Newtons.	4 weeks	Yes
Secondary	Changes in the pressure pain threshold	It will be determined with digital algometer in kilopascal	4 weeks	Yes
Secondary	Changes in pain and function	For these measures will be used the DASH and SPADI questionnaires	4 weeks	Yes