Cervical Proprioception and Shoulder Impingement Treatment

Shoulder Pain Clinical Trial

Official title:

Efficacy of Cervical Proprioceptive Exercises in Treating Shoulder Impingement Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963789
• Other study ID #: P.T.REC/012/004185
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Salwa F Abdel Majeed
• Phone: 01008565476
• Email: dr_Salwa_fadl[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Other:
• Cervical proprioceptive training
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 exercises
Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF

Locations

Country	Name	City	State
Egypt	Fatma eldesoky Ramadan	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks