Changes in Subjects With Posterior Capsule Tightness

• ClinicalTrials.gov Identifier: NCT02353442
• Recruitment Status: Completed
• First Posted: February 2, 2015
• Results First Posted: February 15, 2017
• Last Update Posted: March 21, 2017
• Sponsor: Universidade Federal de Sao Carlos
• Information provided by (Responsible Party): Dayana Patricia Rosa, Universidade Federal de Sao Carlos

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Shoulder Pain	Other: Posterior shoulder mobilizations; Other: External rotators strengthening; Other: Placebo ultrasound; Other: Scapular squeezing; Other: Upper trapezius stretching; Other: Posterior Capsule Stretching	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment
• Study Start Date: March 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control group; This group will perform during 4 weeks: placebo ultrasound during 5min ;; scapular squeezing in the sitting position (3x10repetitions);; upper trapezius stretching (in sitting position, 3x30s and 30s of rest).	Other: Placebo ultrasound; A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.; Other: Scapular squeezing; Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.; Other: Upper trapezius stretching; Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
Active Comparator: Experimental group; This group will perform during 4 weeks: posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);; external rotators strengthening in sidelying positions with load (3x10repetitions);; posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).	Other: Posterior shoulder mobilizations; A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.; Other: External rotators strengthening; Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.; Other: Posterior Capsule Stretching; Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.

Outcome Measures

Primary Outcome Measures :

1. Scapular Kinematics at 4weeks (Pre and Post Treatment) [ Time Frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment) ]
   It was assessed in degrees with 3D system pre and post treatment.
2. Humeral Translations at 4weeks (Pre and Post Treatment). [ Time Frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment) ]
   It was assessed in millimeters with 3D system pre and post treatment.

Secondary Outcome Measures :

1. Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment). [ Time Frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment) ]
   The strength was evaluated with digital dynamometer in Newton pre and post treatment.
2. Pressure Pain Threshold at 4weeks (Pre and Post Treatment). [ Time Frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment) ]
   It was measured by a digital algometer in kPa pre and post treatment.
3. Pain and Function at 4weeks (Pre and Post Treatment) [ Time Frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment) ]
   For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

UFSCar

São Carlos, São Paulo, Brazil, 13565-905

Sponsors and Collaborators

Universidade Federal de Sao Carlos

Investigators

• Principal Investigator: Dayana Rosa, Ms; UFSCar

More Information

• Responsible Party: Dayana Patricia Rosa, Universidade Federal de São Carlos, Universidade Federal de Sao Carlos
• ClinicalTrials.gov Identifier: NCT02353442
• Other Study ID Numbers: 860.648
• First Posted: February 2, 2015
• Results First Posted: February 15, 2017
• Last Update Posted: March 21, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Dayana Patricia Rosa, Universidade Federal de Sao Carlos:

Pain; Rotator cuff; Stretching; Mobilization; Scapula; Posterior capsule

Additional relevant MeSH terms:

Shoulder Pain; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations