- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05963789
Cervical Proprioception and Shoulder Impingement Treatment
July 25, 2023 updated by: Fatma eldesoky, Cairo University
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Salwa F Abdel Majeed
- Phone Number: 01008565476
- Email: dr_Salwa_fadl@live.com
Study Locations
-
-
Al Qahirah
-
Cairo, Al Qahirah, Egypt
- Recruiting
- Fatma eldesoky Ramadan
-
Contact:
- Fatma Eldesoki, Doctoral
- Phone Number: 01157564905
- Email: fatmadesoqipt1990@gmail.com
-
Contact:
- Fatma Eldesoky, Doctoral
- Phone Number: 01157564905
- Email: fatmadesoqipt1990@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A or cervical proprioception group CPG
Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer
|
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.
Other Names:
|
|
Active Comparator: Group B or control group CG
Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization)
|
Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain and disability
Time Frame: 4 weeks
|
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.
|
4 weeks
|
|
Cervical proprioception
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdel Majeed, Professor at orthopedic department, faculty of physical therapy, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
May 12, 2023
First Submitted That Met QC Criteria
July 25, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004185
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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