Shoulder ImpingementNCT05963789
Cervical Proprioception and Shoulder Impingement Treatment
A study testing Cervical proprioceptive training and Traditional exercises in people with Shoulder Impingement and Shoulder Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study will be to investigate the role of cervical proprioceptive training on shoulder proprioception, pain, and disability in shoulder impingement syndrome patients Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Shoulder Impingement, Shoulder Pain
- What is being tested?
- Cervical proprioceptive training and Traditional exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to Oct 2023
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Shoulder impingement syndrome (defined as patients with at least 3 out of the following 6 criteria; Positive "Neer's sign", Positive "Hawkins' sign", Pain with active shoulder elevation in the scapular plane, Pain in the C5-C6 dermatome, Pain with palpation of the rotator cuff tendons, and Pain with resisted isometric abduction.
- Patients with positive apprehension sign for anterior instability.
- Age 25-40years. 4-BMI<32 kg/m2.
Who cannot join
- Shoulder osteoarthritis
- Shoulder trauma
- Shoulder infection
- Intra-articular corticosteroid or hyaluronic acid injection within the last 3 months.
- Previous surgery of the affected shoulder. - Symptomatic cervical pathology.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fatma eldesoky Ramadan
Cairo, Cairo Governorate
Fatma Eldesoki, Doctoral, 01157564905, fatmadesoqipt1990@gmail.com
Fatma Eldesoky, Doctoral, 01157564905, fatmadesoqipt1990@gmail.com
About this study
Official title: Efficacy of Cervical Proprioceptive Exercises in Treating Shoulder Impingement Syndrome
The aim of this study will be to investigate the role of cervical proprioceptive training on shoulder proprioception, pain, and disability in shoulder impingement syndrome patients
Read the detailed description
Study design: This study will be randomized controlled trial 1. Participants: fifty males and females patients with functional shoulder impingement, aged from 25-40 years with BMI <32kg/m2. Sample size calculation: The sample size is 50 patients in the 2 experimental groups based on power analysis done calculating effect size from outcomes of previous study (effect size d of 0.82 for shoulder proprioception) . Power analysis was done using G*power software. Power set to (0.8), significance (0.05). Procedture: First, eligible patients will have the purpose of the study and the procedures fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed and randomly assigned in one of two groups. Afterwards Prior to starting of the study each patient will sign informed consent Patients will be assigned to two groups randomly (by closed envelope method). All subjects will be evaluated for their shoulder pain, disability level, and proprioception. All patients will be tested before and after the treatment program (12 treatment sessions, 3 sessions per week for 4 weeks) Conventional Physical therapy: a. Cross-body stretch b. Sleeper stretch. c. Prone extension with an externally rotated (thumb out) position d. Prone horizontal abduction e. PNF D2 flexion For intervention group it will take Cervical proprioceptive training Retraining joint position sense will be done with a laser pointer. The laser pointer will fixed on the highest point of the subject head with a band. In this exercise, patients sit upright on a chair and kept their head at the neutral position while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position . Temporary reproduction of dizziness is acceptable however exacerbation of neck pain or headache is not acceptable. If this occurs the exercises should be modified by decreasing the number of repetitions or altering the patient position to a more supported position. Progression of exercise set can be achieved by altering the duration, repetitions and the degree of difficulty of the task. Exercises can also be progressed by performing activities such as an eye task or cervical JPS practice while sitting on an unstable surface or while standing with the feet in an unstable base of support for example, heel toe stance, or while walking .
- Conditions
- Shoulder Impingement, Shoulder Pain
- Being tested
- Cervical proprioceptive training, Traditional exercises
- Keywords
- Cervical Proprioceptive Exercises, Shoulder pain, Shoulder disability, Shoulder proprioception
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical proprioceptive trainingOther
Also called Traditional exercises
Cervical proprioceptive training: The laser pointer will fixed on the highest point of the subject head with a band, patients sit upright on a chair and kept their head at the neutral position, while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position.
Traditional exercisesOther
Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF
| Study group | Role | What they receive |
|---|---|---|
| Group A or cervical proprioception group CPG | Experimental | Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer Receives: Other: Cervical proprioceptive training |
| Group B or control group CG | Active comparator | Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization) Receives: Other: Traditional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder proprioception
Joint position sense (Active joint angular reproduction) will be measured with bubble inclinometer during shoulder IR and ER 300 as reference angles from modified neutral position of the arm (shoulder abducted 30O, horizontally adducted 30O and elbow flexed 90o), visual cues are often negated.
Measured: 4 weeks
Secondary outcomes (2)
Pain and disability
Participants will fill the questionnaire of shoulder pain and disability index (SPADI, . Scores will be calculated as follow, scores in all questions will be added in each section separately.
Measured: 4 weeks
Cervical proprioception
Cervical active JPS will be measured using Revel's laser method to record joint position error (JPE). Cervical Joint Position Error (JPE) is the ability to relocate the head to a beginning position following a dynamic active cervical range of motion.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma eldesoky, Cairo University
- Investigators
- Abdel Majeed, Principal investigator, Professor at orthopedic department, faculty of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963789
- Sponsor's protocol ID
- P.T.REC/012/004185
- Status last verified
- Jul 2023
- First submitted
- 12 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cervical Proprioceptive Exercises in Treating Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05963789
- Acronym / sponsor ID
- P.T.REC/012/004185
- Conditions
- Shoulder Impingement, Shoulder Pain
- Keywords
- Cervical Proprioceptive Exercises, Shoulder pain, Shoulder disability, Shoulder proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 Jul 2023 (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 aim of this study will be to investigate the role of cervical proprioceptive training on shoulder proprioception, pain, and disability in shoulder impingement syndrome patients
Detailed description
Study design: This study will be randomized controlled trial 1. Participants: fifty males and females patients with functional shoulder impingement, aged from 25-40 years with BMI <32kg/m2. Sample size calculation: The sample size is 50 patients in the 2 experimental groups based on power analysis done calculating effect size from outcomes of previous study (effect size d of 0.82 for shoulder proprioception) . Power analysis was done using G*power software. Power set to (0.8), significance (0.05). Procedture: First, eligible patients will have the purpose of the study and the procedures fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed and randomly assigned in one of two groups. Afterwards Prior to starting of the study each patient will sign informed consent Patients will be assigned to two groups randomly (by closed envelope method). All subjects will be evaluated for their shoulder pain, disability level, and proprioception. All patients will be tested before and after the treatment program (12 treatment sessions, 3 sessions per week for 4 weeks) Conventional Physical therapy: a. Cross-body stretch b. Sleeper stretch. c. Prone extension with an externally rotated (thumb out) position d. Prone horizontal abduction e. PNF D2 flexion For intervention group it will take Cervical proprioceptive training Retraining joint position sense will be done with a laser pointer. The laser pointer will fixed on the highest point of the subject head with a band. In this exercise, patients sit upright on a chair and kept their head at the neutral position while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position . Temporary reproduction of dizziness is acceptable however exacerbation of neck pain or headache is not acceptable. If this occurs the exercises should be modified by decreasing the number of repetitions or altering the patient position to a more supported position. Progression of exercise set can be achieved by altering the duration, repetitions and the degree of difficulty of the task. Exercises can also be progressed by performing activities such as an eye task or cervical JPS practice while sitting on an unstable surface or while standing with the feet in an unstable base of support for example, heel toe stance, or while walking .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A or cervical proprioception group CPG | Experimental | Other: Cervical proprioceptive trainingPatients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer |
| Group B or control group CG | Active comparator | Other: Traditional exercisesPatients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Shoulder impingement syndrome (defined as patients with at least 3 out of the following 6 criteria; Positive "Neer's sign", Positive "Hawkins' sign", Pain with active shoulder elevation in the scapular plane, Pain in the C5-C6 dermatome, Pain with palpation of the rotator cuff tendons, and Pain with resisted isometric abduction.
- Patients with positive apprehension sign for anterior instability.
- Age 25-40years. 4-BMI<32 kg/m2.
Key exclusion criteria (5 listed)
- Shoulder osteoarthritis
- Shoulder infection
- Intra-articular corticosteroid or hyaluronic acid injection within the last 3 months.
- Previous surgery of the affected shoulder. - Symptomatic cervical pathology.
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 |
|---|---|---|
| Cervical proprioceptive trainingAlso: Traditional exercisesCervical proprioceptive training: The laser pointer will fixed on the highest point of the subject head with a band, patients sit upright on a chair and kept their head at the neutral position, while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position. | Other | Group A or cervical proprioception group CPG |
| Traditional exercisesStretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF | Other | Group B or control group CG |
Primary outcome
Shoulder proprioception
Time frame: 4 weeks
Joint position sense (Active joint angular reproduction) will be measured with bubble inclinometer during shoulder IR and ER 300 as reference angles from modified neutral position of the arm (shoulder abducted 30O, horizontally adducted 30O and elbow flexed 90o), visual cues are often negated.
2 secondary outcomes
Pain and disability
Time frame: 4 weeks
Cervical proprioception
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
Abdel Majeed principal investigator
Professor at orthopedic department, faculty of physical therapy, 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 Cervical proprioceptive training and Traditional exercises in people with Shoulder Impingement and Shoulder Pain, 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 3 inclusion and 5 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 27 Jul 2023. 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 Salwa F Abdel Majeed (01008565476, dr_Salwa_fadl@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder proprioception (time frame: 4 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 27 Jul 2023.