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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03044236
Other study ID # 5170032
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2017
Est. completion date June 1, 2019

Study information

Verified date August 2018
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study.


Description:

To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study. The investigators hypothesize that this type of novel intervention will help subjects with GIRD to restore range of motion, experience less pain and maintain the strength and motor unit recruitment following the novel intervention. This will help us to assess the potential beneficial effect of such intervention and to fill the gap in knowledge and help health care professionals to adequately select the right treatment modality.

Independent Variable

1. Type of Intervention:

- Traditional Stretching (Modified Sleep Stretch). VS

- Novel Stretching (Active Shoulder Internal Rotation while Bridging) 2. Time

- Pre VS post intervention Dependent Variables

1. Glenohumeral internal rotation ROM

2. Maximal glenohumeral external rotation isometric strength.

3. Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)

4. Pain

5. Subject satisfaction

Instrumentation :

1. Glenohumeral internal & external rotation ROM: will be measured at baseline and at week four-post intervention for all participants. We will use the digital inclinometer. Research by (Kolber et al.,2011 ) showed this instrument to be reliable with an intra-rater ICC =0.87 and inter-rater ICC =0.93

2. Electronic push/pull dynamometer: At the end feel ROM, and before ROM is measured, the therapist will apply the same amount of pressure to all subjects to ensure reliable/ valid ROM measurements.

3. Maximal Glenohumeral External Rotation Isometric Strength will be measured using a MicroFET2 handheld digital dynamometer. This device was shown to be reliable with an intra-rater ICC =0.85 and inter-rater ICC =0.85.

4. Maximum Voluntary Contraction: will be measured using a 44 Delsys Bagnoli portable surface electromyography (sEMG) system.

5. Pain: will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS has shown to have a valid, reliable and appropriate for use in clinical practice

Procedures:

All participants will perform the static stretching (SS) conditions by themselves. The two stretching techniques will be home-based program.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date June 1, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Participants must be between the age of 18 and 45.

- Perform overhead sports activities in the past 3 months.

- Participants are required to display = 20° less glenohumeral internal rotation ROM in their dominant shoulder compare to the non- dominate shoulder.

- Participants will be included with or without pain during shoulder activities.

Exclusion Criteria:

- Will exclude participants who are still recovering from previous surgery of the shoulder and elbow complex in the past 3 months, and currently receiving medical intervention for the shoulder.

Study Design


Related Conditions & MeSH terms

  • Glenohumeral Internal Rotation Deficits

Intervention

Procedure:
Stretching
The novel stretching technique will be done on a supine position. subjects will be asked bridge as high as possible. After That, Participants will then flex their shoulder and elbow to 90°. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.

Locations

Country Name City State
United States Loma Linda U Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi) will be measured using surface electromyography (sEMG) system Change from baseline at week 4
Other Pain will be measured using the Numeric Pain Rating Scale will be measured using the Numeric Pain Rating Scale Change from baseline at week 4
Other Subject satisfaction will be measured using the Subject satisfaction Form will be measured using the Subject satisfaction Form Week 4
Primary Glenohumeral internal rotation ROM The investigators will use the digital inclinometer Change from baseline at week 4
Secondary Maximal glenohumeral external rotation isometric strength will be measured using a MicroFET2 handheld digital dynamometer Change from baseline at week 4