Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome

Impingement Syndrome, Shoulder Clinical Trial

Official title:

The Relative Effect of Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468088
• Other study ID #: CAMS 039-3839
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2018
• Last updated: March 11, 2018
• Start date: February 1, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: March 2018
• Source: King Saud University
• Contact: Sami Gabr, PhD
• Phone: +966562060018
• Email: nadalab2009[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the relative effect of handgrip strengthening exercise in improving function, pain, strength, and active range of motion (AROM) of the shoulder among patients with primary sub-acromial impingement syndrome (SAIS).

Description:

The current study is a Single-Blind Randomized Clinical Trial to investigate the effectiveness of handgrip strengthening exercise in the treatment of patients with primary subacromial impingement syndrome. The randomization process will be based on concealed envelop picked up by participants.The patient will be conveniently recruited from the ministry of health hospitals in Jeddah.The patient who will meet the inclusion criteria; they will sign the consent form. The baseline data will be collected. The assessment will be carried out at the baseline, 4 weeks and 8 weeks; end of the treatment program; by the same blinded examiner for each patient and consist of the following instrument: Disabilities of Arm, Shoulder & Hand (DASH questionnaire), Visual analog scale (VAS), Hand-held dynamometer (HHD), and smartphone clinometer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Willing to comply with all study procedures and be available for the duration of the study

• Aged 18 to 45

• Diagnosed by their referring physician with subacromial impingement syndrome and has a positive impingement & rotator cuff test

• Pain intensity between 3 to 8 in VAS

Exclusion Criteria:

• History of shoulder fracture or dislocation, osteophytes, and labral tear.

• History of cardiac, neurological or musculoskeletal disease that precludes the ability to perform the exercise in the upper extremity.

• Treatment with another intervention.

• Hand or forearm dysfunction

• Rheumatoid disease

• Diabetic

• History of shoulder, cervical, and thoracic surgery

• Pregnancy

• Malignancy

• Symptoms for more than 1 year

• Bilateral SAIS

Related Conditions & MeSH terms

• Impingement Syndrome, Shoulder
• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Syndrome

Intervention

Behavioral:
• Hand grip strengthening
Handgrip strengthening exercises will be added to the experimental group. This exercise is chosen based on literature review of EMG and biomechanical studies. Adjustable heavy grip hand gripper will be used as handgrip resistance at 10 repetitions maximum (RM). The exercise will be performed in standing position the patient's back will be rested in a wall, arm at 30º abduction, 60º abduction 90º abduction & with 90º ER. In this positions, the patient will be performed 3 sets of 10 squeezes each at a 1-minute interval.
• Conventional treatment
Ultrasound therapy will be used to treat both groups. Ultrasound will be applied; while the patient will be seated in an adjustable chair with back support, feet on the floor. The chair will be positioned beside a table. The patient's shoulder will be rested on the table beside the body and elbow will be flexed at 90°. A round-headed probe will be used that is put in direct contact with the patient's skin over the shoulder joint. Ultrasound gel will be used on all surfaces of the head in order to reduce friction and assist in the transmission of the ultrasonic waves.

Locations

Country	Name	City	State
Saudi Arabia	Ministry of Health Hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function	It will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, which is a 30-item questionnaire that assess the ability of a patient to perform various upper extremity activities. it uses a 5-point Likert scale. A higher scores signify a greater level of disability, whereas, lower scores signify a lower level of disability.	Change from baseline functional score at 8 weeks
Secondary	Strength	It will be assessed using HHD	Change from baseline muscle strength at 8 weeks
Secondary	Range of motion	It will be assessed using smartphone clinometer	Change from baseline range of motion at 8 weeks
Secondary	Pain	Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).	Change from baseline pain intensity at 8 weeks