Neck PainNCT03537300
Efficacy of Deep Cervical Flexor Muscles Training on Neck Pain, Functional Disability and Muscle Endurance in School Teachers
A study testing DCF muscles training using pressure biofeedback in addition to conventional exercises and conventional exercises in people with Neck Pain, run by King Saud University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- DCF muscles training using pressure biofeedback in addition to conventional exercises and conventional exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- any neurological sign or symptom, history of spinal surgery or if they were taking any treatment for their pain.
About this study
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- DCF muscles training using pressure biofeedback in addition to conventional exercises, conventional exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCF muscles training using pressure biofeedback in addition to conventional exercisesBehavioural
DCF muscles training using pressure biofeedback in addition to conventional exercises
conventional exercisesBehavioural
conventional exercises
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Behavioral: DCF muscles training using pressure biofeedback in addition to conventional exercises |
| control group | Active comparator | Not described Receives: Behavioral: conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain at day 42, day 14 after intervention from baseline
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.
Measured: 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
Craniocervical flexion test (CCF) test using pressure biofeedback instrument
Measured: at day 0 (before treatment), day 14 and day 42 after treatment
Secondary outcomes (1)
disability
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.
Measured: at day 0 (before treatment), day 14 and day 42 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start21 May 2016
- Primary completion1 Jan 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaheen A. Iqbal, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537300
- Sponsor's protocol ID
- RRC-2016-009
- Status last verified
- May 2018
- First submitted
- 13 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.
PubMed 33521131
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deep Cervical Flexor Muscles Training on Neck Pain, Functional Disability and Muscle Endurance in School Teachers
- ClinicalTrials.gov ID
- NCT03537300
- Acronym / sponsor ID
- RRC-2016-009
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 21 May 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: DCF muscles training using pressure biofeedback in addition to conventional exercises |
| control group | Active comparator | Behavioral: conventional exercises |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- any neurological sign or symptom, history of spinal surgery or if they were taking any treatment for their pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCF muscles training using pressure biofeedback in addition to conventional exercisesDCF muscles training using pressure biofeedback in addition to conventional exercises | Behavioural | experimental group |
| conventional exercisesconventional exercises | Behavioural | control group |
Primary outcome
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.
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
1 secondary outcome
disability
Time frame: at day 0 (before treatment), day 14 and day 42 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Derived from this study: PubMed 33521131Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DCF muscles training using pressure biofeedback in addition to conventional exercises and conventional exercises in people with Neck Pain, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03537300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.