NCT05963789

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

May 12, 2023

Last Update Submit

July 25, 2023

Conditions

Shoulder ImpingementShoulder Pain

Keywords

Cervical Proprioceptive ExercisesShoulder painShoulder disabilityShoulder proprioception

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain and disability

    4 weeks

  • Cervical proprioception

    4 weeks

Study Arms (2)

Group A or cervical proprioception group CPG

EXPERIMENTAL

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

Other: Cervical proprioceptive training

Group B or control group CG

ACTIVE COMPARATOR

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

Other: Traditional exercises

Interventions

Cervical proprioceptive trainingOTHER

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.

Also known as: Traditional exercises
Group A or cervical proprioception group CPG
Traditional exercisesOTHER

Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF

Group B or control group CG

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma eldesoky Ramadan

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdel Majeed

    Professor at orthopedic department, faculty of physical therapy, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salwa F Abdel Majeed

CONTACT

01008565476dr_Salwa_fadl@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist at 23rd of July hospital, PhD candidate physiotherapy, Cairo university

Study Record Dates

First Submitted

May 12, 2023

First Posted

July 27, 2023

Study Start

August 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

EG(1)