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

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

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).

Study Overview

• Status: Unknown
• Conditions: Impingement Syndrome, Shoulder
• Intervention / Treatment: Behavioral: Hand grip strengthening; Behavioral: Conventional treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sami Gabr, PhD; Phone Number: +966562060018; Email: nadalab2009@hotmail.com

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Recruiting
    • Ministry of Health Hospital
    • Contact: Amal AlAnazi; Phone Number: +966535924417; Email: amalalanazi600@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hand grip strengthening; This group will receive handgrip strengthening exercises.	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.
ACTIVE_COMPARATOR: Conventional treatment; This group will receive conventional exercises.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	It will be assessed using HHD	Change from baseline muscle strength at 8 weeks
Range of motion	It will be assessed using smartphone clinometer	Change from baseline range of motion at 8 weeks
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

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Amal AlAnazi, King Saud University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ANTICIPATED): August 15, 2018
• Study Completion (ANTICIPATED): December 15, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 11, 2018
• First Posted (ACTUAL): March 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: CAMS 039-3839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be kept secure with the principal investigator (Ms. Amal AlAnazi) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No