Impingement Syndrome, ShoulderNCT03468088
Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
A study testing Hand grip strengthening and Conventional treatment in people with Impingement Syndrome, Shoulder, run by King Saud University at 1 site in Saudi Arabia.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Syndrome, Shoulder
- What is being tested?
- Hand grip strengthening and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- History of shoulder, cervical, and thoracic surgery
- Pregnancy
- Malignancy
- Symptoms for more than 1 year
- Bilateral SAIS
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Ministry of Health Hospital
Jeddah
Amal AlAnazi, +966535924417, amalalanazi600@gmail.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Impingement Syndrome, Shoulder
- Being tested
- Hand grip strengthening, Conventional treatment
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip strengtheningBehavioural
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 treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hand grip strengthening | Experimental | This group will receive handgrip strengthening exercises. Receives: Behavioral: Hand grip strengthening |
| Conventional treatment | Active comparator | This group will receive conventional exercises. Receives: Behavioral: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline functional score at 8 weeks
Secondary outcomes (3)
Strength
It will be assessed using HHD
Measured: Change from baseline muscle strength at 8 weeks
Range of motion
It will be assessed using smartphone clinometer
Measured: 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).
Measured: Change from baseline pain intensity at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Feb 2018
- Primary completion15 Aug 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impingement Syndrome, ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Alanazi, King Saud University
- Investigators
- Amal AlAnazi, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468088
- Sponsor's protocol ID
- CAMS 039-3839
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept secure with the principal investigator (Ms. Amal AlAnazi) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Effect of Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT03468088
- Acronym / sponsor ID
- CAMS 039-3839
- Conditions
- Impingement Syndrome, Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand grip strengthening | Experimental | Behavioral: Hand grip strengtheningThis group will receive handgrip strengthening exercises. |
| Conventional treatment | Active comparator | Behavioral: Conventional treatmentThis group will receive conventional exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand grip strengtheningHandgrip 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. | Behavioural | Hand grip strengthening |
| Conventional treatmentUltrasound 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. | Behavioural | Conventional treatment |
Primary outcome
Function
Time frame: Change from baseline functional score at 8 weeks
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.
3 secondary outcomes
Strength
Time frame: Change from baseline muscle strength at 8 weeks
Range of motion
Time frame: Change from baseline range of motion at 8 weeks
Pain
Time frame: Change from baseline pain intensity at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No. Data will be kept secure with the principal investigator (Ms. Amal AlAnazi) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal AlAnazi principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand grip strengthening and Conventional treatment in people with Impingement Syndrome, Shoulder, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sami Gabr, PhD (+966562060018, nadalab2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function (time frame: Change from baseline functional score at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.