Chronic Neck PainNCT03121859
Analgesic Current Therapies for Chronic Neck Pain
A study testing Neck stabilization exercise, TENS and IFC in people with Chronic Neck Pain, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
Trial summary
Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Neck stabilization exercise, TENS and IFC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2015to 1 Apr 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders between 20-50 years, had chronic neck pain
- Exclusion Criteria: Having disc hernia that causes neurological deficit
- Having malignity,
- Having neck pain secondary neurological or vascular disease.
- Pregnancy
- Having psychiatric disease
- Having arthritic disease
- Having any contraindication for electrotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hilal Yesil
Afyonkarahisar, Eyalet/Yerleşke, 0300
About this study
Official title: Does The Use Of Analgesic Current Therapies Increase The Effectiveness Of Neck Stabilization Exercises For Improving Pain, Disability, Mood, And Quality Of Life In Chronic Neck Pain? A Randomized, Controlled, Single-Blind Study
Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study
Read the detailed description
Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) have been applied solo or combined with exercise for management of neck pain (NP), however, the efficacy of these combinations are unclear. In this study, our objective were to determine if TENS or IFC increase the effectiveness of neck stabilization exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III: IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)), quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program.
- Conditions
- Chronic Neck Pain
- Being tested
- Neck stabilization exercise, TENS, IFC
- Keywords
- TENS, interferential current therapy, Chronic neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck stabilization exerciseOther
Exercise
TENSOther
Transcutaneous electrical nerve stimulation (TENS)
IFCOther
Interferential current therapy(IFC)
| Study group | Role | What they receive |
|---|---|---|
| Neck stabilization exercise | Active comparator | The patients who had only neck stabilization exercise Receives: Other: Neck stabilization exercise |
| TENS+ neck stabilization exercise | Active comparator | The patients who had both TENS and neck stabilization exercise Receives: Other: Neck stabilization exercise; Other: TENS |
| IFC+ neck stabilization exercise | Active comparator | The patients who had both interferential current therapy and neck stabilization exercise Receives: Other: Neck stabilization exercise; Other: IFC |
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 weeks
The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).
Measured: Up to12 weeks
Secondary outcomes (3)
Change from baseline quality of life (short form- 36) at 6th and 12th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.
Measured: Up to 12 weeks
Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks
The Beck Depression Inventory (BDI); was used to assess the depression levels of the patients. The BDI evaluates 21 symptoms of depression. These symptoms deal with emotions, behavioral changes, and somatic symptoms. Each symptom is rated on a 4-point intensity scale. Higher scores indicate more severe depression
Measured: Up to 12 weeks
Change from baseline Neck Pain and Disability Index at 6th and 12th weeks
The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100.
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 posted20 Apr 2017
- Study start1 Oct 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yeşil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yeşil, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121859
- Sponsor's protocol ID
- 2017-SHHY
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does The Use Of Analgesic Current Therapies Increase The Effectiveness Of Neck Stabilization Exercises For Improving Pain, Disability, Mood, And Quality Of Life In Chronic Neck Pain? A Randomized, Controlled, Single-Blind Study
- ClinicalTrials.gov ID
- NCT03121859
- Acronym / sponsor ID
- 2017-SHHY
- Conditions
- Chronic Neck Pain
- Keywords
- TENS, interferential current therapy, Chronic neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hilal YeşilUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 20 Apr 2017 (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.
Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study
Detailed description
Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) have been applied solo or combined with exercise for management of neck pain (NP), however, the efficacy of these combinations are unclear. In this study, our objective were to determine if TENS or IFC increase the effectiveness of neck stabilization exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III: IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)), quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neck stabilization exercise | Active comparator | Other: Neck stabilization exerciseThe patients who had only neck stabilization exercise |
| TENS+ neck stabilization exercise | Active comparator | Other: Neck stabilization exercise, Other: TENSThe patients who had both TENS and neck stabilization exercise |
| IFC+ neck stabilization exercise | Active comparator | Other: Neck stabilization exercise, Other: IFCThe patients who had both interferential current therapy and neck stabilization exercise |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Both genders between 20-50 years, had chronic neck pain
- Exclusion Criteria: Having disc hernia that causes neurological deficit
- Having malignity,
- Having neck pain secondary neurological or vascular disease.
- Pregnancy
Key exclusion criteria (0 listed)
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 exerciseExercise | Other | IFC+ neck stabilization exercise, Neck stabilization exercise, TENS+ neck stabilization exercise |
| TENSTranscutaneous electrical nerve stimulation (TENS) | Other | TENS+ neck stabilization exercise |
| IFCInterferential current therapy(IFC) | Other | IFC+ neck stabilization exercise |
Primary outcome
Change from baseline VAS (Visual analog scale) at 6th and 12th weeks
Time frame: Up to12 weeks
The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).
3 secondary outcomes
Change from baseline quality of life (short form- 36) at 6th and 12th weeks
Time frame: Up to 12 weeks
Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks
Time frame: Up to 12 weeks
Change from baseline Neck Pain and Disability Index at 6th and 12th weeks
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 20 Apr 2017.
- Individual participant dataSharing planned: No
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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, TENS and IFC in people with Chronic 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 8 inclusion and 0 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 20 Apr 2017. 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 weeks (time frame: Up to12 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 20 Apr 2017.