NCT06594809

Brief Summary

To study the combination of upper extremity PNF patterns and SS exercises on improving neck pain, function, scapular position, and scapular muscles strength in patients with NSCNP and SD.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 9, 2024

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • scapular muscle strength

    Hand-held dynamometer (HHD) (Model 01165, Lafayette Instrument Company, Indiana) is an easy and reliable device to assess isometric muscle strength for shoulder and scapular muscles in both clinical and research settings The patient will be instructed to maintain the midrange position during each muscle test as resistance was gradually applied via the HHD until the examiner matches the subject's effort Assess upper trapezius, middle trapezius, lower trapezius, and serratus anterior

    up to 4 weeks

  • Assessment of scapular posture

    Assessment of scapular posture by lateral scapular slide test, It used to determine scapula involves measuring the distance from the inferior angle of the scapula to the nearest vertebral spinous process using a tape measure or goniometer in three positions: shoulder in neutral, shoulder at 45 degrees of coronal plane abduction with hands resting on hips, and the shoulder at 90 degrees abduction with the arms in full internal rotation.

    up to 4 weeks

Study Arms (3)

Group one

PLACEBO COMPARATOR

Neck-focused training consisted of a) cervical stretching, b) craniocervical flexion, and c) cervical retraction exercises d) Manual therapy, for three sessions per week for four weeks (Yildiz et al., 2018).

Other: Traditional neck pain treatment

Group two

ACTIVE COMPARATOR

The patients will receive Traditional treatment of neck pain and Scapular stabilization exercises (Blackburn exercises).

Other: Traditional neck pain treatment + Blackburn scapular stabilization exercises

Group three

EXPERIMENTAL

Patients will receive combination of traditional treatment of neck pain, SS (Blackburn exercises) and upper extremity PNF patterns.

Other: PNF

Interventions

PNFOTHER

Upper extremity PNF exercise is an exercise method that dynamically stabilizes the scapula and affect scapular muscles activity (Witt et al., 2011). Upper extremity PNF patterns consisted of four diagonal patterns (D1 flexion, D2 flexion, D1 extension, and D2 extension) and six key components manual contact, body position, verbal cues pattern of movement, timing of movement and resistance. Patient will be at sitting position with involved side up, head, spine, and scapula in neutral

Group three

Cervical muscles stretch + Craniocervical retraction ex + Manual therapy

Group one

The patients will receive Traditional treatment of neck pain and Scapular stabilization exercises (Blackburn exercises). Blackburn exercises are one of the ways to treat scapular dyskinesia. Perform 2 sets of 20 repetitions of each exercise each session (3 sessions per week) for four weeks (panse et al .,2018). The exercise load will be 60% of the one-repetition maximum (1-RM) during the first week due to their first exposure to the exercises. The evaluation of one-repetition maximum (1-RM) will be every week for all exercises. From the second evaluation, more weight will be added (compare to the previous evaluation) to maintain the overload.

Group two

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have referred from orthopedic surgeon diagnosed with non specific chronic neck pain (NSCNP) that has been localized to the cervical and periscapular areas for at least three months.
  • Aged from 18-40 years. 3- Having a score more than 10 on the Neck disability index (NDI). 4- Having SD according to Kibler's description. 5- BMI from 18.5 to 29.9 kg/m2.

You may not qualify if:

  • History of previous neck surgery.
  • Recent or old fractures.
  • Cognitive impairment and inability to understand the scale.
  • Systematic inflammatory disease e.g., rheumatoid arthritis and ankylosing spondylitis, neck pain with radiculopathy or neuropathy.
  • Scapular dyskinesia due to other pathology such as shoulder impingement.
  • A score of below 10 or above 40 points out of 50 on the NDI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Giza, 387722, Egypt

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A triple-blinded randomized controlled trial will be conducted, ensuring that patients, the research assistant (who serves as the examiner for all patients), and the statistician are blinded to the treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer orthopedic department faculty of physical therapy Cairo university

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations