Neck PainNCT05509491
Effectiveness of A Telehealth Postural Awareness Program Combined With Exercise In People With Neck Pain
A study testing A postural awareness program with exercises in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
People with neck pain often experience pain, neck disability, and poor quality of life. Postural-based awareness programs are evidence-based interventions for postural problems and neck pain disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- A postural awareness program with exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2022to 20 May 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being aged 18 years or over,
- volunteering to take part in the study,
- being a student of online education,
- without a history of any neurological or orthopedic problem,
- with resting neck pain (as measured by the VAS) lasting ≤30 days
- that is aggravated by movement without extending distal to the shoulders.
Who cannot join
- rheumatological diseases, malignity or structural deformities,
- previous surgical intervention related to the neck region,
- severe pain (more than 7 in 0 to 10 VAS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postural Awareness Program With Exercises In Patients With Neck Pain
People with neck pain often experience pain, neck disability, and poor quality of life. Postural-based awareness programs are evidence-based interventions for postural problems and neck pain disorders. This study aims to determine the effectiveness of a telehealth physiotherapist-delivered postural awareness program combined with exercise in people with neck pain. Pain, neck disability, leisure time management, and exercise stage of change were evaluated.
Read the detailed description
Pain with visual analog scale, neck disability with Neck Disability Index, Leisure time management with Leisure Time Management Scale, and exercise stage of change with exercise Stage of change Scale were determined. The authors aim to find out if there are any changes before and after the program on the pain, neck disability, and evaluation subscale of the leisure time management scale, and exercise stage of change of participants.
- Conditions
- Neck Pain
- Being tested
- A postural awareness program with exercises
- Keywords
- neck pain, neck, telehealth, awareness, posture, exercise
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A postural awareness program with exercisesBehavioural
A program about postural awareness, bad posture, good posture and their effects on daily life
| Study group | Role | What they receive |
|---|---|---|
| Postural Awareness Program with Exercises in people with neck pain | Experimental | Postural education, bad posture, good posture, awareness, their effects in daily life Receives: Behavioral: A postural awareness program with exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Visual Analog Scale- The evaluations of this study was performed at beginning and end of study. Neck pain was determined with Visual Analog Scale with 0 indicating "no pain", 10 indicating "the most severe pain
Measured: 5 minute
Secondary outcomes (3)
Neck Disability
Neck Disability Index-The Neck Disability Index consists of 10 items: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. Individuals included in the study were asked to rate each title between 0 (no disability) and 5 (complete disability). The total score ranges between 0 (no disability) and 50 (complete disability)
Measured: 10 minute
Leisure Time Management
Leisure Time Management- This scale consists of four sub-dimensions and 15 items. These sub-dimensions were investigated as "evaluation", "programming", "leisure attitude", "goal setting and method". The answer codes of each item vary between 1 and 5 as a Likert type.
Measured: 10 minute
Exercise Stage of Change
Exercise Stage of Change Scale-The "Exercise Behavior Change Steps Questionnaire" aims to determine the individual's exercise behavior steps. The four items in the questionnaire, in which the participants' wishes for exercise are tried to be determined, are answered as yes/no. Individuals' intention to exercise and their habits of participating in exercise are divided into five different exercise behavior steps according to their responses to the items: Pre-tendency, Tendency, Preparation, Movement and Continuity.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start5 Feb 2022
- Primary completion10 Apr 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 12-week physiotherapist delivered a postural awareness program with exercises
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Tezel Y Şahan, pHD, Study chair, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509491
- Sponsor's protocol ID
- 2022-191
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors decided that if a researcher want ıpd than they will send them with e mail
Publications
Bennell KL, Jones SE, Hinman RS, McManus F, Lamb KE, Quicke JG, Sumithran P, Prendergast J, George ES, Holden MA, Foster NE, Allison K. Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.
PubMed 35907828Alfawaz S, Lohman E, Alameri M, Daher N, Jaber H. Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial. J Bodyw Mov Ther. 2020 Jul;24(3):50-58. doi: 10.1016/j.jbmt.2020.02.020. Epub 2020 Feb 22.
PubMed 32826008Toprak Celenay S, Mete O, Sari A, Ozer Kaya D. A comparison of kinesio taping and classical massage in addition to cervical stabilization exercise in patients with chronic neck pain. Complement Ther Clin Pract. 2021 May;43:101381. doi: 10.1016/j.ctcp.2021.101381. Epub 2021 Apr 2.
PubMed 33831805Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.
PubMed 28146026
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Awareness Program With Exercises In Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT05509491
- Acronym / sponsor ID
- 2022-191
- Conditions
- Neck Pain
- Keywords
- neck pain, neck, telehealth, awareness, posture, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 22 Aug 2022 (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.
People with neck pain often experience pain, neck disability, and poor quality of life. Postural-based awareness programs are evidence-based interventions for postural problems and neck pain disorders. This study aims to determine the effectiveness of a telehealth physiotherapist-delivered postural awareness program combined with exercise in people with neck pain. Pain, neck disability, leisure time management, and exercise stage of change were evaluated.
Detailed description
Pain with visual analog scale, neck disability with Neck Disability Index, Leisure time management with Leisure Time Management Scale, and exercise stage of change with exercise Stage of change Scale were determined. The authors aim to find out if there are any changes before and after the program on the pain, neck disability, and evaluation subscale of the leisure time management scale, and exercise stage of change of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12-week physiotherapist delivered a postural awareness program with exercises
| Arm | Type | Receives |
|---|---|---|
| Postural Awareness Program with Exercises in people with neck pain | Experimental | Behavioral: A postural awareness program with exercisesPostural education, bad posture, good posture, awareness, their effects in daily life |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- being aged 18 years or over,
- volunteering to take part in the study,
- being a student of online education,
- without a history of any neurological or orthopedic problem,
- with resting neck pain (as measured by the VAS) lasting ≤30 days
Key exclusion criteria (3 listed)
- rheumatological diseases, malignity or structural deformities,
- previous surgical intervention related to the neck region,
- severe pain (more than 7 in 0 to 10 VAS)
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 |
|---|---|---|
| A postural awareness program with exercisesA program about postural awareness, bad posture, good posture and their effects on daily life | Behavioural | Postural Awareness Program with Exercises in people with neck pain |
Primary outcome
Neck pain
Time frame: 5 minute
Visual Analog Scale- The evaluations of this study was performed at beginning and end of study. Neck pain was determined with Visual Analog Scale with 0 indicating "no pain", 10 indicating "the most severe pain
3 secondary outcomes
Neck Disability
Time frame: 10 minute
Leisure Time Management
Time frame: 10 minute
Exercise Stage of Change
Time frame: 10 minute
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 22 Aug 2022.
- Background: PubMed 35907828Bennell KL, Jones SE, Hinman RS, McManus F, Lamb KE, Quicke JG, Sumithran P, Prendergast J, George ES, Holden MA, Foster NE, Allison K. Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.
- Background: PubMed 32826008Alfawaz S, Lohman E, Alameri M, Daher N, Jaber H. Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial. J Bodyw Mov Ther. 2020 Jul;24(3):50-58. doi: 10.1016/j.jbmt.2020.02.020. Epub 2020 Feb 22.
- Background: PubMed 33831805Toprak Celenay S, Mete O, Sari A, Ozer Kaya D. A comparison of kinesio taping and classical massage in addition to cervical stabilization exercise in patients with chronic neck pain. Complement Ther Clin Pract. 2021 May;43:101381. doi: 10.1016/j.ctcp.2021.101381. Epub 2021 Apr 2.
- Background: PubMed 28146026Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.
- Individual participant dataSharing planned: No. The authors decided that if a researcher want ıpd than they will send them with e mail
Related trials for Neck Pain
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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.
Tezel Y Şahan, pHD study chair
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A postural awareness program with exercises in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Neck pain (time frame: 5 minute). 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 NCT05509491, which also lists 4 linked publications.
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 22 Aug 2022.