- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537300
Efficacy of Deep Cervical Flexor Muscles Training on Neck Pain, Functional Disability and Muscle Endurance in School Teachers
May 24, 2018 updated by: Zaheen A. Iqbal, King Saud University
Neck pain (NP) is a common work related disorder.
Teaching is one profession in which its prevalence is high.
The Daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing NP.
Deep cervical flexor (DCF) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability.
There is limited evidence that reports efficacy of DCF muscles training in occupational NP.
This study was done to see the effect of DCF muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with NP.
Study Overview
Status
Completed
Conditions
Detailed Description
Neck pain (NP) is a common work related disorder.
Teaching is one profession in which its prevalence is high.
The Daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing NP.
Deep cervical flexor (DCF) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability.
There is limited evidence that reports efficacy of DCF muscles training in occupational NP.
This study was done to see the effect of DCF muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with NP. 65 teachers, aged between 25 to 45 years with experience of more than 5 years were agreed to participate in this study.
Subjects were randomly divided into two groups, experimental (EG) and control group (CG).
In EG, subjects received DCF muscles training using pressure biofeedback in addition to conventional exercises for neck pain while in CG subjects received only conventional exercises.
Pain, muscle endurance and disability measured at day 0 (before treatment), day 14 and day 42 after treatment.
Endurance of DCF muscles was measured by CCF test using pressure biofeedback instrument, Pain intensity was measured using NPRS and Functional disability was assessed using NDI questionnaire.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- experience of more than 5 years
- neck pain score of more than 5 on numeric pain rating scale (NPRS), mild to moderate disability score on neck disability index (NDI) and poor cranio-cervical flexion (CCF) test
Exclusion Criteria:
- any neurological sign or symptom, history of spinal surgery or if they were taking any treatment for their pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
|
DCF muscles training using pressure biofeedback in addition to conventional exercises
|
Active Comparator: control group
|
conventional exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain at day 42, day 14 after intervention from baseline
Time Frame: at day 0 (before treatment), day 14 and day 42 after treatment
|
Numeric pain rating scale (NPRS): NPRS.
Subjects had to rate their pain on the 0-10 rating scale, where 0 means no pain while 10 is the worst possible pain.
|
at day 0 (before treatment), day 14 and day 42 after treatment
|
Change in muscle endurance at day 42, day 14 after intervention from baseline
Time Frame: at day 0 (before treatment), day 14 and day 42 after treatment
|
Craniocervical flexion test (CCF) test using pressure biofeedback instrument
|
at day 0 (before treatment), day 14 and day 42 after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disability
Time Frame: at day 0 (before treatment), day 14 and day 42 after treatment
|
Functional disability was assessed using Neck disability index (NDI) questionnaire.
Subjects had to answer the multiple choice questions and their score was interpreted on range from 0 to 50, 0 being no disability and 50 indicating complete disability.
|
at day 0 (before treatment), day 14 and day 42 after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
May 13, 2018
First Submitted That Met QC Criteria
May 24, 2018
First Posted (Actual)
May 25, 2018
Study Record Updates
Last Update Posted (Actual)
May 25, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2016-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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