NCT05261854

Brief Summary

The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

February 20, 2022

Last Update Submit

June 20, 2022

Conditions

Keywords

Neck painDisabiltyMuscle endurancePressure biofeedbackTeachers

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating Scale

    Numeric pain rating scale used to determine pain intensity experienced by individuals. It consist of a horizontal or vertical line with total of 11 numbers,ranging from 0 to 10. Where 0 indicates no pain while 10 is the worst pain.

    8th week

  • Inclinometer

    It is an instrument used for measuring the angles of tilt,elevation and depression of an object with respect to gravity.

    8th week

  • Cranio-cervical flexion test

    It is a clinical test of the anatomical action of the deep cervical flexor muscles. It could be described as a test of neuromotor control. The features assessed are the activation and isometric endurance of the deep cervical flexors

    8th week

  • Neck Disability index

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.

    8th week

Study Arms (2)

Deep cervical muscle training using pressure biofeedback and conventional Exercises

EXPERIMENTAL

The duration of preesure biofeedback includes 3 sets in a session with 10 repetitions each with 2 minutes of rest between sets and 5 days a week for 6 weeks. Conventional exercises like Stretching and strengthening of neck flexor muscles will include 10 repetitions, each held for 10s with rest of 2 minutes between sets. The session will be conducted for 6 weeks, 5 days a week.

Device: Pressure biofeedback

conventional exercises for Neck pain

EXPERIMENTAL

Only conventional exercises like stretching and strengthening of neck flexor muscles will be given.

Other: Conventional exercises for deep cervical muscle training

Interventions

Deep cervical flexor training by using preesure biofeedback will be given 5 days a week for 6 week Conventional exercise for deep cervical muscle training will be given 5 days a week for 6 weeks

Deep cervical muscle training using pressure biofeedback and conventional Exercises

Conventional exercise for deep cervical muscle training will be given 4 days a week for 6 weeks

conventional exercises for Neck pain

Eligibility Criteria

Age24 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both gender
  • age between 24 to 45 years
  • At least 4 years of teaching experience and average 8 hours of working per day
  • Chronic Neck pain score of more than 5 on numeric pain rating scale
  • Mild to moderate disability Score on neck disability index

You may not qualify if:

  • Participants with any ongoing treatment for neck pain
  • History of cervical spine surgery or reported any neurological signs.
  • History of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study Would be double blind as the identity of patients group will not be revealed to the assessor and the patient will also be unaware of group to which they will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 2, 2022

Study Start

May 1, 2021

Primary Completion

March 25, 2022

Study Completion

April 5, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations