Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
Primary Purpose
Impingement Syndrome, Shoulder
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Hand grip strengthening
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Impingement Syndrome, Shoulder
Eligibility Criteria
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
Sites / Locations
- Ministry of Health HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand grip strengthening
Conventional treatment
Arm Description
This group will receive handgrip strengthening exercises.
This group will receive conventional exercises.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Strength
It will be assessed using HHD
Range of motion
It will be assessed using smartphone clinometer
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03468088
Brief Title
Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
Official Title
The Relative Effect of Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Anticipated)
Study Completion Date
December 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impingement Syndrome, Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hand grip strengthening
Arm Type
Experimental
Arm Description
This group will receive handgrip strengthening exercises.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
This group will receive conventional exercises.
Intervention Type
Behavioral
Intervention Name(s)
Hand grip strengthening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Function
Description
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.
Time Frame
Change from baseline functional score at 8 weeks
Secondary Outcome Measure Information:
Title
Strength
Description
It will be assessed using HHD
Time Frame
Change from baseline muscle strength at 8 weeks
Title
Range of motion
Description
It will be assessed using smartphone clinometer
Time Frame
Change from baseline range of motion at 8 weeks
Title
Pain
Description
Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).
Time Frame
Change from baseline pain intensity at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sami Gabr, PhD
Phone
+966562060018
Email
nadalab2009@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal AlAnazi
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health Hospital
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal AlAnazi
Phone
+966535924417
Email
amalalanazi600@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept secure with the principal investigator (Ms. Amal AlAnazi) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
Learn more about this trial
Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
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