NCT03468088

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

February 27, 2018

Last Update Submit

March 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Strength

    Change from baseline muscle strength at 8 weeks

  • Range of motion

    Change from baseline range of motion at 8 weeks

  • Pain

    Change from baseline pain intensity at 8 weeks

Study Arms (2)

Hand grip strengthening

EXPERIMENTAL

This group will receive handgrip strengthening exercises.

Behavioral: Hand grip strengthening

Conventional treatment

ACTIVE COMPARATOR

This group will receive conventional exercises.

Behavioral: Conventional treatment

Interventions

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.

Hand grip strengthening

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.

Conventional treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Hospital

Jeddah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Amal AlAnazi

    King Saud University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate student, Principal Investigator

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 16, 2018

Study Start

February 1, 2018

Primary Completion

August 15, 2018

Study Completion

December 15, 2018

Last Updated

March 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Data will be kept secure with the principal investigator (Ms. Amal AlAnazi) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues

Locations