Subacromial Impingement SyndromeNCT06301490
The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome
A study testing Myofascial Release in people with Subacromial Impingement Syndrome, run by Taif University at 1 site in Saudi Arabia.
Trial summary
BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Myofascial Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Jan 2024to 2 Mar 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are aged between 20-60 years old,
- have one or more than one positive finding in one of the following categories: (1) painful arc of movement during flexion or abduction; (2) Neer (sensitivity 0.78, specificity 0.58) or Kennedy-Hawkins (sensitivity 0.74, specificity 0.57) impingement signs[28]; and (3) pain during resisted external rotation, abduction or empty can test (sensitivity 0.69, specificity 0.62).[29] A combination of positive results to these clinical tests has values ≥ 0.74 for sensitivity and specificity for SIS.
Who cannot join
- have a history of glenohumeral luxation in the last 12 months or any fracture to the shoulder girdle.
- have a shoulder pain reproduced by cervical movements. had a previous shoulder surgery, adhesive capsulitis, defined as loss of passive shoulder ROM greater than 50%, and
- have a clinical sign of full-thickness tears of any rotator cuff muscles identified by lag signs [30]: drop sign (sensitivity 0.73, specificity 0.77), external rotation sign (sensitivity 0.46, specificity 0.94) and internal rotation sign (sensitivity 1.00, specificity 0.84).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome Randomized Controlled Trial
BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.
OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.
METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Myofascial Release
- 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.
Myofascial ReleaseOther
Myofascial release is a popular hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex (directly or indirectly), with the goal of restoring appropriate length, decreasing discomfort, and improving range of motion, muscle recovery, and physical performance in healthy persons.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins |
| experimental group | Experimental | 18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins, with adding Myofascial Release Receives: Other: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The pain intensity will be assessed using the visual analogue scale (VAS) which assess pain from 0 (no pain) to 10 (most severe pain) and has good reliability and validity
Measured: one month
disability
The disability will be assessed using Quick DASH. The Arabic Q-DASH questionnaire consist of eleven questions that measures the disability of upper extremity, ranges from 0-100 a higher score indicates a higher disability, and it is a reliable and valid upper extremity outcome measure for assessing patients with various upper extremity disorders
Measured: one month
Secondary outcomes (2)
rang of motion
ROM will be measured in standing position for shoulder flexion, extension, and abduction, supine position for internal rotation, and external rotation with a two-arm standard goniometer with a good reliability
Measured: one month
psychological distress, and health-related quality of life (HRQoL)
HRQoL will be assessed using Kessler psychological distress scale, the questionnaire consists of ten questions, and scoring from 10-50 while 10 means likely will and 50 means likely to have a sever disorder, and it is valid and reliable
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start11 Jan 2024
- Primary completion15 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Muawidh Alqarafi, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301490
- Sponsor's protocol ID
- Taif university
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06301490
- Acronym / sponsor ID
- Taif university
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 8 Mar 2024 (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.
BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.
OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.
METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins |
| experimental group | Experimental | Other: Myofascial Release18 participants will have strengthening exercises, rang of motion exercises and ice application for 10 mins, with adding Myofascial Release |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- are aged between 20-60 years old,
- have one or more than one positive finding in one of the following categories: (1) painful arc of movement during flexion or abduction; (2) Neer (sensitivity 0.78, specificity 0.58) or Kennedy-Hawkins (sensitivity 0.74, specificity 0.57) impingement signs[28]; and (3) pain during resisted external rotation, abduction or empty can test (sensitivity 0.69, specificity 0.62).[29] A combination of positive results to these clinical tests has values ≥ 0.74 for sensitivity and specificity for SIS.
Key exclusion criteria (3 listed)
- have a history of glenohumeral luxation in the last 12 months or any fracture to the shoulder girdle.
- have a shoulder pain reproduced by cervical movements. had a previous shoulder surgery, adhesive capsulitis, defined as loss of passive shoulder ROM greater than 50%, and
- have a clinical sign of full-thickness tears of any rotator cuff muscles identified by lag signs [30]: drop sign (sensitivity 0.73, specificity 0.77), external rotation sign (sensitivity 0.46, specificity 0.94) and internal rotation sign (sensitivity 1.00, specificity 0.84).
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 |
|---|---|---|
| Myofascial ReleaseMyofascial release is a popular hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex (directly or indirectly), with the goal of restoring appropriate length, decreasing discomfort, and improving range of motion, muscle recovery, and physical performance in healthy persons. | Other | experimental group |
Primary outcome
pain intensity
Time frame: one month
The pain intensity will be assessed using the visual analogue scale (VAS) which assess pain from 0 (no pain) to 10 (most severe pain) and has good reliability and validity
disability
Time frame: one month
The disability will be assessed using Quick DASH. The Arabic Q-DASH questionnaire consist of eleven questions that measures the disability of upper extremity, ranges from 0-100 a higher score indicates a higher disability, and it is a reliable and valid upper extremity outcome measure for assessing patients with various upper extremity disorders
2 secondary outcomes
rang of motion
Time frame: one month
psychological distress, and health-related quality of life (HRQoL)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release in people with Subacromial Impingement Syndrome, run by Taif 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: one month). The study lists 2 primary outcomes in all. 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 24 Apr 2024.