NCT05026086

Brief Summary

Neck pain is defined as the pain experienced from the base of the skull or occiput to the upper part of the back and extending laterally to the outer and superior bounds of the shoulder blade. Office work is a kind of job that demands sitting for prolonged time requiring the use of computer. These two factors are mainly responsible for overloading of the spine. Neck pain and computer users are clearly connected due to extended periods of sitting in a certain position with no breaks to stretch the neck muscles. Prolonged computer use with neck bent forward will cause the anterior neck muscles to gradually get shorter and tighter, while the muscles in the back of neck will grow longer and weaker. These changes will lead to development of neck pain. Neck problem also accounts for a large proportion of occupational illness and disability. Neck pain is common among computer workers in our country and contributes importantly to the demand for medical services and the economic burden of absence from work due to sickness. The main purpose of this randomized clinical trial will be to find out the effects of Isometric exercises with and without Pressure Biofeedback Unit on Cervical pain and Muscle strength in Computer users with cervical spine overload. Patients will be recruited in the study by convenient sampling technique after that will be allocated to groups by simple random assignment with an inclusion criteria having chronic neck pain for more than 3 months, current pain level ranging greater than 3 on NPRS, patient with minimum and moderate disability and male and female computer users with age 25 to 40 years with cervical pain. Patients with history of cervical trauma, postural deformity, spinal cord deformity, current pregnancy and significant neurological deficits were excluded. Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) will be used to measure before and after treatment session. Treatment will be given to both groups for 4 weeks and each group will receive 3 sessions per week. After collecting the data it will entered and analysed using Statistical Package for the Social Sciences (SPSS) version 25. Data will be assessed by using parametric/ non parametric test after completion of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

April 21, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • pain of patient

    NPRS The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    4 weeks

  • function

    Neck Disability index (NDI) Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)

    4 weeks

Study Arms (2)

biofeedback

EXPERIMENTAL

10 patients will be treated with isometric exercises and pressure biofeedback.

Other: pressure biofeedback

isometric exercises

ACTIVE COMPARATOR

10 patients will be treated with isometric exercises without pressure biofeedback.

Other: isometric exercises

Interventions

10 patients will be treated with isometric exercises and pressure biofeedback.

biofeedback

10 patients will be treated with isometric exercises

isometric exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 20-40 years among male and female with cervical pain
  • Having chronic pain for more than 3 months.
  • Current pain level ranging greater than 3 on NPRS
  • Patients with minimum and moderate disability based on NDI

You may not qualify if:

  • History of cervical trauma
  • Postural deformity
  • Spinal cord deformity ( scoliosis, kyphosis, lordosis)
  • Current pregnancy
  • Significant neurological deficits ( cervical radiculopathy, cervical spondylosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Hahim

Lahore, Ppunjab, 54000, Pakistan

Location

Related Publications (4)

  • Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

    PMID: 28807894BACKGROUND
  • Barrett JM, McKinnon C, Callaghan JP. Cervical spine joint loading with neck flexion. Ergonomics. 2020 Jan;63(1):101-108. doi: 10.1080/00140139.2019.1677944. Epub 2019 Oct 15.

    PMID: 31594480BACKGROUND
  • Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.

    PMID: 28602744BACKGROUND
  • Khan R, Surti A, Rehman R, Ali U. Knowledge and practices of ergonomics in computer users. J Pak Med Assoc. 2012 Mar;62(3):213-7.

    PMID: 22764450BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 30, 2021

Study Start

August 5, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations