Shoulder Impingement SyndromeNCT06195956
The Effect of Lower Limb Kinetic Chain Exercise in Shoulder Impingement
A study testing exercise in people with Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial study is to investigate the effect of performing lower limb kinetic chain exercise on muscle activation of scapular muscle strength ratio in patients with shoulder impingement. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 1 Oct 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges between 20 and 45 years old
- Unilateral shoulder pain lasting more than 6 weeks
- At least one positive finding in each of these categories:
- Painful arc of movement during flexion or abduction
- Positive Neer or Hawkins-Kennedy impingement signs
- Pain on resisted lateral rotation, abduction or Jobe test
Who cannot join
- History of surgery
- History of fracture or dislocation
- Type III acromion
- Rotator cuff tear
- Long head of biceps tendon tear
- Cervical radiculopathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient physical therapy, Faculty of physical therapy
Giza, 2334
Ahmed ElMelhat, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: Effects of Lower Limb Kinetic Chain Exercise to Shoulder Rehabilitation Program in Patients With Shoulder Impingement Syndrome
The goal of this clinical trial study is to investigate the effect of performing lower limb kinetic chain exercise on muscle activation of scapular muscle strength ratio in patients with shoulder impingement. the main question it aims to answer is:
Does the addition of lower limb kinetic chain exercise to a shoulder exercise program improve scapular muscles strength ratio in patients with shoulder impingement? participants will be devided into two groups to be compared: The first group will be given a rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) The second group will be given the same exercises in addition to lower limb kinetic chain exercise
Read the detailed description
The term "kinetic chain" (KC) describes the sequential activation of body segments during functional movement patterns (Wilk et al., 2016). An effective KC will produce, summate, and enable effective mechanical energy transmission along the entire chain, which will support function. Any link in the KC that is inefficient has the potential to adversely affect force transfer to nearby segments (Ben kibler et al., 2000 \& Martic et al., 2014). Consequently, therapists usually recommend incorporating trunk and lower extremity movements into shoulder rehabilitation programs in order to maximize efficient energy transfer throughout the entire KC (Sciascia et al., 2012 \& Magarey et al., 2003). Thus, the investigators hypothesize that adding a lower limb (LL) kinetic chain exercise to a shoulder exercise program will improve scapular muscles strength ratio.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- exercise
- 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.
exerciseOther
Exercises done 3 times per weeks, 3 repetitions per exercise for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Impingement Rehabilitation | Active comparator | rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula).
Exercises done 3 times per weeks, 3 repetitions per exercise for 3 months Receives: Other: exercise |
| Shoulder Impingement Rehabilitation with LL KC Exercise | Experimental | rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) in addition to lower limb kinetic chain exercise.
Exercises done 3 times per weeks, 3 repetitions per exercise for 3 months Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography to evaluate the activation patterns, timing and ratio of scapular muscles during movement
EMG activity of the three trapezius parts (upper, middle and lower) and Serratus anterior will be evaluated.
- Electrodes for registration of upper trapezius activity are placed halfway between the spinous process of C7 and the posterior acromion.
- Electrodes for registration of middle trapezius activity are placed halfway on the horizontal line between the thoracic spine and the root of the scapular spine.
- Electrodes for registration of Lower trapezius activity are placed obliquely upward and laterally along a line between the intersection of the scapular spine with the vertebral border of the scapula and the seventh thoracic spinous process.
- Electrodes for registration of Serratus Anterior activity are applied anterior to the latissimus dorsi and posterior to the pectoralis major
Measured: baseline
Secondary outcomes (1)
Shoulder pain and disability Index
To test pain and functional disability before and after interventions. 0-20: mild shoulder pain and disability 21-40: moderate shoulder pain and disability 41-60: severe shoulder pain and disability 61-80: very severe shoulder pain and disability 81-100: extremely severe shoulder pain and disability
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Jan 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195956
- Sponsor's protocol ID
- kinetic chain exercise
- Status last verified
- Aug 2024
- First submitted
- 25 Dec 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wilk KE, Arrigo CA, Hooks TR, Andrews JR. Rehabilitation of the Overhead Throwing Athlete: There Is More to It Than Just External Rotation/Internal Rotation Strengthening. PM R. 2016 Mar;8(3 Suppl):S78-90. doi: 10.1016/j.pmrj.2015.12.005.
PubMed 26972270Sciascia A, Thigpen C, Namdari S, Baldwin K. Kinetic chain abnormalities in the athletic shoulder. Sports Med Arthrosc Rev. 2012 Mar;20(1):16-21. doi: 10.1097/JSA.0b013e31823a021f.
PubMed 22311288
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Limb Kinetic Chain Exercise to Shoulder Rehabilitation Program in Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06195956
- Acronym / sponsor ID
- kinetic chain exercise
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Jan 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.
The goal of this clinical trial study is to investigate the effect of performing lower limb kinetic chain exercise on muscle activation of scapular muscle strength ratio in patients with shoulder impingement. the main question it aims to answer is:
Does the addition of lower limb kinetic chain exercise to a shoulder exercise program improve scapular muscles strength ratio in patients with shoulder impingement? participants will be devided into two groups to be compared: The first group will be given a rehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) The second group will be given the same exercises in addition to lower limb kinetic chain exercise
Detailed description
The term "kinetic chain" (KC) describes the sequential activation of body segments during functional movement patterns (Wilk et al., 2016). An effective KC will produce, summate, and enable effective mechanical energy transmission along the entire chain, which will support function. Any link in the KC that is inefficient has the potential to adversely affect force transfer to nearby segments (Ben kibler et al., 2000 \& Martic et al., 2014). Consequently, therapists usually recommend incorporating trunk and lower extremity movements into shoulder rehabilitation programs in order to maximize efficient energy transfer throughout the entire KC (Sciascia et al., 2012 \& Magarey et al., 2003). Thus, the investigators hypothesize that adding a lower limb (LL) kinetic chain exercise to a shoulder exercise program will improve scapular muscles strength ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Impingement Rehabilitation | Active comparator | Other: exerciserehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula). Exercises done 3 times per weeks, 3 repetitions per exercise for 3 months |
| Shoulder Impingement Rehabilitation with LL KC Exercise | Experimental | Other: exerciserehabilitation program consisting of strengthening exercises (for scapular stabilizers and rotator cuff) and stretching exercises (for pectoralis major, pectoralis minor, latissimus dorsi, levator scapula) in addition to lower limb kinetic chain exercise. Exercises done 3 times per weeks, 3 repetitions per exercise for 3 months |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ranges between 20 and 45 years old
- Unilateral shoulder pain lasting more than 6 weeks
- At least one positive finding in each of these categories:
Key exclusion criteria (6 listed)
- History of surgery
- History of fracture or dislocation
- Type III acromion
- Rotator cuff tear
- Long head of biceps tendon tear
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 |
|---|---|---|
| exerciseExercises done 3 times per weeks, 3 repetitions per exercise for 3 months | Other | Shoulder Impingement Rehabilitation, Shoulder Impingement Rehabilitation with LL KC Exercise |
Primary outcome
Electromyography to evaluate the activation patterns, timing and ratio of scapular muscles during movement
Time frame: baseline
EMG activity of the three trapezius parts (upper, middle and lower) and Serratus anterior will be evaluated. 1. Electrodes for registration of upper trapezius activity are placed halfway between the spinous process of C7 and the posterior acromion. 2. Electrodes for registration of middle trapezius activity are placed halfway on the horizontal line between the thoracic spine and the root of the scapular spine. 3. Electrodes for registration of Lower trapezius activity are placed obliquely upward and laterally along a line between the intersection of the scapular spine with the vertebral border of the scapula and the seventh thoracic spinous process. 4. Electrodes for registration of Serratus Anterior activity are applied anterior to the latissimus dorsi and posterior to the pectoralis major
1 secondary outcome
Shoulder pain and disability Index
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 26972270Wilk KE, Arrigo CA, Hooks TR, Andrews JR. Rehabilitation of the Overhead Throwing Athlete: There Is More to It Than Just External Rotation/Internal Rotation Strengthening. PM R. 2016 Mar;8(3 Suppl):S78-90. doi: 10.1016/j.pmrj.2015.12.005.
- Background: PubMed 22311288Sciascia A, Thigpen C, Namdari S, Baldwin K. Kinetic chain abnormalities in the athletic shoulder. Sports Med Arthrosc Rev. 2012 Mar;20(1):16-21. doi: 10.1097/JSA.0b013e31823a021f.
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Subacromial Impingement Syndrome
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Natural History of Shoulder Pathology in Manual Wheelchair Users
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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.
Ahmed El Melhat, Phd study director
Cairo 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 exercise in people with Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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 21 Aug 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 Egypt. 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 Ahmed El Melhat, Phd (01112595022, ahmed.elmelhat@cu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography to evaluate the activation patterns, timing and ratio of scapular muscles during movement (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195956, which also lists 2 linked publications.
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 21 Aug 2024.