NCT05845853

Brief Summary

The purpose of this study is to investigate the effect of motor control training using scapular PNF exercise on neck pain, function, proprioception, and scapular muscle strength in patients with chronic mechanical neck pain.

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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

March 25, 2023

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • change in cervical pain

    by using the Arabic version of Numeric pain rating scale , ranging from 0 ("no pain") to 10 ("worst pain imaginable")

    one week after end of treatment

  • change in neck function

    by using the Arabic version of neck disability index that consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (total disability). The maximum possible score is 50.

    one week after end of treatment

  • change in proprioceptive inputs of cervical

    Bubble Inclinometer will be used to assess proprioceptive inputs of cervical * flexion - extension * right side bending - left side bending * cervical right rotate - cervical left rotation

    one week after end of treatment

  • change in muscle strength

    Hand-held dynamometer will be used to assess muscle strength * upper trapezius - middle trapezius * lower trapezius - serratus anterior

    one week after end of treatment

Study Arms (2)

interventinal group

EXPERIMENTAL

28 subject will receive a program of scapular motor control exercises using PNF technique in addition to the conventional treatment for 18 sessions (3 sessions per week for six weeks)

Other: scapular PNF technique

control group

NO INTERVENTION

28 subject will receive conventional physical therapy program (heat-TENS) for 18 sessions (3 sessions per week for six weeks)

Interventions

PNF Technique is based on movement patterns to facilitate and correct sensory-motor function,then correct the impaired impulses emerging from proprioceptive receptors in the muscle. Therefore, it decreases pain and improve the strength of muscles. PNF position renders a greater amount of sensory input coming from the periphery than that in the neutral position .

interventinal group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The subject will be referred from orthopedic surgeon with diagnosis of CMNP.
  • Subjects with CMNP of more than 3 months with age range between 18 and 45 years
  • Subjects having a baseline NDI score of at least 20% (10 points)
  • At least 3/10 pain intensity on VAS

You may not qualify if:

  • Spinal canal stenosis.
  • Traumatic injury to the cervical spine.
  • Previous surgery related to cervical spine.
  • Hypermobility of the cervical spine,
  • Any red flags e.g. cervical instability, history of cancer, long use of corticosteroids.
  • Presence of an inflammatory rheumatologic disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tala Central Hospital

Tala, Munofia, Egypt

RECRUITING

Tala Central Hospital

Tala, Egypt

NOT YET RECRUITING

Related Links

Central Study Contacts

Aisha said, master

CONTACT

mohammed abdelmaged

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patients will be randomly assigned into one of the two groups. We will use a simple randomization method to allocate participants to the groups. A random number generator available online from www.randomization.com will be used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a double blinded, randomized, controlled, pre-post test clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 25, 2023

First Posted

May 6, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations