Neck PainNCT05771441
Effects of Neck Stabilization Exercise With Heat Therapies
A study testing neck stabilization exercise (nse), NSE + HOT PACK THERAPY and NSE + infrared therapy in people with Neck Pain, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- neck stabilization exercise (nse), NSE + HOT PACK THERAPY and NSE + infrared therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 1 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with chronic neck pain
Who cannot join
- sensory deficit on neck area, servical disc pathologies, neurological deficit, malignity, secondary causes for neck pain, active inflammation, arthritis on the neck area, serious mental health problems, pregnancy, spine surgery, and having received treatment to the cervical region in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Heat Therapies on Pain, Functional Status, Range of Motion, and Disability in Patients With Neck Pain
In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.
Read the detailed description
Chronic non-specific neck pain (NP) has become one of the main causes of disability in the adult population around the world.Several treatment options used like; exercise, manual therapy, electrotherapy, and hot treatments etc. In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.100 patients with NP will be included.Patients will be randomyl assigned to 4 groups and will receive a total of 3 weeks of treatment. Patients' pain levels (visual analogoue scale VAS), quality of life (short form 36), mood (Beck deppression inventory BDI), range of motion, and neck disability index were evaluated prior to treatment, at 6th and at 12th weeks.
- Conditions
- Neck Pain
- Being tested
- neck stabilization exercise (nse), NSE + HOT PACK THERAPY, NSE + infrared therapy, NSE + ultrasound therapy
- Keywords
- hot pack, exercise, ultrasound therapy
- 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.
neck stabilization exercise (nse)Other
neck stabilization exercise (nse)- exercise
NSE + HOT PACK THERAPYOther
NSE + HOT PACK THERAPY- exercise plus heat therapy
NSE + infrared therapyOther
NSE + infrared therapy- exercise plus heat therapy
NSE + ultrasound therapyOther
NSE + ultrasound therapy exercise plus heat therapy
| Study group | Role | What they receive |
|---|---|---|
| neck stabilization exercise (NSE) | Active comparator | the patients who had NSE Receives: Other: neck stabilization exercise (nse) |
| NSE + HOT PACK THERAPY | Active comparator | the patients who had NSE+ hot pack Receives: Other: NSE + HOT PACK THERAPY |
| NSE + infrared therapy | Active comparator | the patients who had NSE+ infrared therapy Receives: Other: NSE + infrared therapy |
| NSE + ultrasound therapy | Active comparator | the patients who had NSE+ ultrasound therapy Receives: Other: NSE + ultrasound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline VAS (visual analog scale) at 6th and 12th week
The patients were asked to make an assesment of their pain level between 0 and 10 scale
Measured: up to 12 weeks
Secondary outcomes (4)
Change from baseline quality of life (short form 36) at 6th and 12th week
The physical and mental health summary scores were the primary components used. Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life.
Measured: up to 12 weeks
Change from baseline shoulder range of motion (ROM) at 6th and 12th week
The patients' joint range of motion will be measured with a goniometer.
Measured: up to 12 weeks
Change from baseline Beck depression inventory (BDI) at 6th and 12th week
A total Beck score (0-63) is obtained by giving each question a score of 0-3 in the survey. 17 is considered the threshold value for the degree of depression.
Measured: up to 12 weeks
Change from baseline neck disability index (NDI) at 6th and 12th week
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 May 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yeşil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yeşil, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771441
- Sponsor's protocol ID
- HYSHNP
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heat Therapies on Pain, Functional Status, Range of Motion, and Disability in Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT05771441
- Acronym / sponsor ID
- HYSHNP
- Conditions
- Neck Pain
- Keywords
- hot pack, exercise, ultrasound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hilal YeşilUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Mar 2023 (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.
In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.
Detailed description
Chronic non-specific neck pain (NP) has become one of the main causes of disability in the adult population around the world.Several treatment options used like; exercise, manual therapy, electrotherapy, and hot treatments etc. In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.100 patients with NP will be included.Patients will be randomyl assigned to 4 groups and will receive a total of 3 weeks of treatment. Patients' pain levels (visual analogoue scale VAS), quality of life (short form 36), mood (Beck deppression inventory BDI), range of motion, and neck disability index were evaluated prior to treatment, at 6th and at 12th weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| neck stabilization exercise (NSE) | Active comparator | Other: neck stabilization exercise (nse)the patients who had NSE |
| NSE + HOT PACK THERAPY | Active comparator | Other: NSE + HOT PACK THERAPYthe patients who had NSE+ hot pack |
| NSE + infrared therapy | Active comparator | Other: NSE + infrared therapythe patients who had NSE+ infrared therapy |
| NSE + ultrasound therapy | Active comparator | Other: NSE + ultrasound therapythe patients who had NSE+ ultrasound therapy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with chronic neck pain
Key exclusion criteria (1 listed)
- sensory deficit on neck area, servical disc pathologies, neurological deficit, malignity, secondary causes for neck pain, active inflammation, arthritis on the neck area, serious mental health problems, pregnancy, spine surgery, and having received treatment to the cervical region in the last 6 months
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 |
|---|---|---|
| neck stabilization exercise (nse)neck stabilization exercise (nse)- exercise | Other | neck stabilization exercise (NSE) |
| NSE + HOT PACK THERAPYNSE + HOT PACK THERAPY- exercise plus heat therapy | Other | NSE + HOT PACK THERAPY |
| NSE + infrared therapyNSE + infrared therapy- exercise plus heat therapy | Other | NSE + infrared therapy |
| NSE + ultrasound therapyNSE + ultrasound therapy exercise plus heat therapy | Other | NSE + ultrasound therapy |
Primary outcome
change from baseline VAS (visual analog scale) at 6th and 12th week
Time frame: up to 12 weeks
The patients were asked to make an assesment of their pain level between 0 and 10 scale
4 secondary outcomes
Change from baseline quality of life (short form 36) at 6th and 12th week
Time frame: up to 12 weeks
Change from baseline shoulder range of motion (ROM) at 6th and 12th week
Time frame: up to 12 weeks
Change from baseline Beck depression inventory (BDI) at 6th and 12th week
Time frame: up to 12 weeks
Change from baseline neck disability index (NDI) at 6th and 12th week
Time frame: up to 12 weeks
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 16 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neck stabilization exercise (nse), NSE + HOT PACK THERAPY and NSE + infrared therapy in people with Neck Pain, run by Hilal Yeşil 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 1 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 16 Mar 2023. 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?
change from baseline VAS (visual analog scale) at 6th and 12th week (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.