search
Back to results

Cervical Proprioception and Shoulder Impingement Treatment

Primary Purpose

Shoulder Impingement, Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cervical proprioceptive training
Traditional exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement focused on measuring Cervical Proprioceptive Exercises, Shoulder pain, Shoulder disability, Shoulder proprioception

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fatma eldesoky RamadanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A or cervical proprioception group CPG

Group B or control group CG

Arm Description

Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer

Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 12, 2023
Last Updated
July 25, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05963789
Brief Title
Cervical Proprioception and Shoulder Impingement Treatment
Official Title
Efficacy of Cervical Proprioceptive Exercises in Treating Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement, Shoulder Pain
Keywords
Cervical Proprioceptive Exercises, Shoulder pain, Shoulder disability, Shoulder proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A or cervical proprioception group CPG
Arm Type
Experimental
Arm Description
Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer
Arm Title
Group B or control group CG
Arm Type
Active Comparator
Arm Description
Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization)
Intervention Type
Other
Intervention Name(s)
Cervical proprioceptive training
Other Intervention Name(s)
Traditional exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional exercises
Intervention Description
Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF
Primary Outcome Measure Information:
Title
Shoulder proprioception
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain and disability
Description
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.
Time Frame
4 weeks
Title
Cervical proprioception
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salwa F Abdel Majeed
Phone
01008565476
Email
dr_Salwa_fadl@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdel Majeed
Organizational Affiliation
Professor at orthopedic department, faculty of physical therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatma eldesoky Ramadan
City
Cairo
State/Province
Al Qahirah
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Eldesoki, Doctoral
Phone
01157564905
Email
fatmadesoqipt1990@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatma Eldesoky, Doctoral
Phone
01157564905
Email
fatmadesoqipt1990@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Cervical Proprioception and Shoulder Impingement Treatment

We'll reach out to this number within 24 hrs