Neck PainNCT05851703
The Effects Of Instrument Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques
A study testing Manual therapy application and Proprioceptive Neuromuscular Facilitation in people with Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Read more about this study
- Who is it for?
- Ages 18 months to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual therapy application and Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2023to 26 Apr 2024
- 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 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Those with neck pain
- Being between 20-60 years old
Who cannot join
- High blood pressure
- Cardiopulmonary disease
- Malignant
- Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
- Spine surgery
- Psychological disturbance
- Neurological and orthopedic deficits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ismet Yurtdsever
Istanbul, None Selected, 34353
About this study
Official title: The Effects Of Instrument-Supported Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques
The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Neck pain usually lasts longer than 3 months and results in a high cost to society
Read the detailed description
Movement in one plane in the cervical spine is due to the contribution of vertebrae from other planes. This complicates the kinematics and injury mechanism of the cervical region. Considering the mechanism of injury, demographic information to be obtained from the person is very important.
- Conditions
- Neck Pain
- Being tested
- Manual therapy application, Proprioceptive Neuromuscular Facilitation
- Keywords
- pain
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy applicationOther
In lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present.
In lower cervical lateral flexion problems, instrument-assisted pushing technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present.
Proprioceptive Neuromuscular FacilitationOther
With the rhythmic initiation technique, it is to teach the movement to the person, to improve the feeling of movement, coordination and to help relaxation. With rhythmic initiation, we want the patient's initial passive and then active participation to understand the movement, the direction and rhythm of the movement. After people actively participate, they can use active joint movement.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy applications: | Experimental | In lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present Receives: Other: Manual therapy application |
| Proprioceptive Neuromuscular Facilitation | Experimental | Proprioceptive Neuromuscular Facilitation (PNF) techniques will be applied to the second group. Receives: Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The Neck Disability Index (NDI) measures acute and chronic neck pain or disability due to neck injury. It is the most common assessment tool used in the neck. It consists of 10 items. These; intensity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleep and leisure activities. There are 6 options in each item and the patient will mark one of these options and be evaluated accordingly.
Measured: one day
Visual Analogue Scale
In the measurement of neck pain severity, it was planned to use a standard, proven 10 mm VAS. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively.
Measured: one day
Algometer
It can be used to measure the sensitivity of tissues. The pressure is gradually increased and people must report the feeling of pressure applied. It has been shown that pressure algometry is a highly valid and reliable measurement of cranio-cervical muscles.
Measured: one day
Pinchmeter
It will be used to assess finger grip strengths. Measurements will be evaluated on both hands. Before the measurements, the participants will be informed verbally and they will be allowed to experiment. When the participants are ready, they are asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Participants will rest for 1 minute between measurements.
Measured: one day
Jamar Hand Dynomometer
The patients were placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Before the measurements, the participants will be informed verbally. Participants will then be asked to squeeze with all their strength for 3 seconds and then release. Participants will rest for 1 minute between measurements
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start16 May 2023
- Primary completion16 May 2023
- Study completion26 Apr 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmet Yurdsever, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851703
- Sponsor's protocol ID
- neck pain
- Status last verified
- May 2024
- First submitted
- 30 Apr 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
PubMed 28826164
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Instrument-Supported Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques
- ClinicalTrials.gov ID
- NCT05851703
- Acronym / sponsor ID
- neck pain
- Conditions
- Neck Pain
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 10 May 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.
The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Neck pain usually lasts longer than 3 months and results in a high cost to society
Detailed description
Movement in one plane in the cervical spine is due to the contribution of vertebrae from other planes. This complicates the kinematics and injury mechanism of the cervical region. Considering the mechanism of injury, demographic information to be obtained from the person is very important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy applications: | Experimental | Other: Manual therapy applicationIn lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular FacilitationProprioceptive Neuromuscular Facilitation (PNF) techniques will be applied to the second group. |
Who may qualify
- Ages
- 18 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Those with neck pain
- Being between 20-60 years old
Key exclusion criteria (7 listed)
- High blood pressure
- Cardiopulmonary disease
- Malignant
- Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
- Spine surgery
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 |
|---|---|---|
| Manual therapy applicationIn lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present. In lower cervical lateral flexion problems, instrument-assisted pushing technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present. | Other | Manual therapy applications: |
| Proprioceptive Neuromuscular FacilitationWith the rhythmic initiation technique, it is to teach the movement to the person, to improve the feeling of movement, coordination and to help relaxation. With rhythmic initiation, we want the patient's initial passive and then active participation to understand the movement, the direction and rhythm of the movement. After people actively participate, they can use active joint movement. | Other | Proprioceptive Neuromuscular Facilitation |
Primary outcome
Neck Disability Index
Time frame: one day
The Neck Disability Index (NDI) measures acute and chronic neck pain or disability due to neck injury. It is the most common assessment tool used in the neck. It consists of 10 items. These; intensity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleep and leisure activities. There are 6 options in each item and the patient will mark one of these options and be evaluated accordingly.
Visual Analogue Scale
Time frame: one day
In the measurement of neck pain severity, it was planned to use a standard, proven 10 mm VAS. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively.
Algometer
Time frame: one day
It can be used to measure the sensitivity of tissues. The pressure is gradually increased and people must report the feeling of pressure applied. It has been shown that pressure algometry is a highly valid and reliable measurement of cranio-cervical muscles.
Pinchmeter
Time frame: one day
It will be used to assess finger grip strengths. Measurements will be evaluated on both hands. Before the measurements, the participants will be informed verbally and they will be allowed to experiment. When the participants are ready, they are asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Participants will rest for 1 minute between measurements.
Jamar Hand Dynomometer
Time frame: one day
The patients were placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Before the measurements, the participants will be informed verbally. Participants will then be asked to squeeze with all their strength for 3 seconds and then release. Participants will rest for 1 minute between measurements
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 14 May 2024.
- Background: PubMed 28826164Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
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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 Manual therapy application and Proprioceptive Neuromuscular Facilitation in people with Neck Pain, run by Bahçeşehir 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 2 inclusion and 7 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 14 May 2024. 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 Disability Index (time frame: one day). The study lists 5 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 NCT05851703, 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 14 May 2024.