Neck PainNCT05567302
Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain
A study testing Manual therapy and myofascial release in people with Neck Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic neck pain is an important health problem in modern society and is frequently encountered today. Approximately 10% of the adult population experiences neck pain at least once in their lives. 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?
- Manual therapy and myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2022to 2 Jan 2023
- 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
- Neck pain
- Being between 20-60 years old
Who cannot join
- Cardiopulmonary disease
- malignancy and pregnancy
- Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
- Spine surgery
- Psychological discomfort
- Neurological and orthopedic deficits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol hospital
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Chronic neck pain is an important health problem in modern society and is frequently encountered today. Approximately 10% of the adult population experiences neck pain at least once in their lives.
Anamnesis of the patient with neck pain; It should include the patient's complaints, illness history, family history, social status, work life and leisure activities.
Read more
The age of the patient, the severity of the symptoms, the mechanism of the injury, the activity history, the duration of the symptoms, the location and limits, the spread of the pain, the relationship of the complaints with the change in position, the restrictions during movement, and the sleeping positions should be taken into account. In addition, past diseases, operations and current diseases, medications used should be recorded.
Among chronic pains, neck pain ranks second after low back pain. Physical stresses in daily living activities, maintaining static posture and sleeping habits, carrying bags and weights in the wrong position, muscle imbalance are important factors in neck pain. Although cervical spine involvements have a great effect on neck pain, almost all of them have paravertebral muscle spasm, especially trapezius muscle spasm. Physiotherapy applications are widely used in the treatment of chronic neck pain.
Read the detailed description
Therapeutic approaches are frequently used to reduce inflammation and accelerate the healing process. Reducing pain in neck diseases, ensuring sufficient length of the muscle, strength balance, improving strength and function, improving postural re-education and cervical movements are the main goals. With the increasing prevalence of neck pain, the search for new treatment methods is increasing.
It includes manual therapy, manipulation, acupuncture, and soft tissue therapy for chronic neck pain. Neck pain results from deep muscle dysfunctions and altered fascia structures. In this case, it may cause the disruption of the continuous musculofacial corset-like system. In addition, changes in the fascia (increased fascial thickness and disruption of fascial alignment) may affect this system more. Myofascial release is one of the soft tissue treatment applications. Although there are studies reporting that myofascial release is a method that can achieve positive effects such as reducing pain intensity and improving muscle function, there are few studies on this subject in the literature and sufficient evidence has not been reached.
- Conditions
- Neck Pain
- Being tested
- Manual therapy, myofascial release
- Keywords
- manuel therapy, neck
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
In lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present.
In lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present.
A rotational maneuver will be performed from the posterior side of the articular pillar part of the superior vertebra, on the opposite side of the side where the movement restriction is present.
myofascial releaseOther
The soft tissue is palpated by the physiotherapist and pressure is applied directly to the skin until the tissue barrier is felt in the direction of restriction. Once the tissue barrier is present, it is applied for 90-120 seconds, without slipping on the skin or forcing the tissue, until the fascia complex begins to loosen and a softening sensation is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Manual therapy, manipulative therapy, is a completely manual treatment method that includes special techniques and is known as a treatment that aims to correct bony deformities and is highly effective when combined with exercise. Receives: Other: Manual therapy |
| myofascial release | Active comparator | Foam rollers are a popular tool for helping athletes release muscle knots or trigger points.Myofascial release is a soft tissue method that provides removal of adhesions and tissue tension in tissues due to overload and repetitive use. Receives: Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
In the measurement of neck pain severity, a standard, proven reliability 10 mm VAS will be used. A value between 0 and 10 will be determined for the VAS, with 0 in the absence of pain and 10 mm in the most severe pain.
Measured: one day
pinchmeter
Finger grip strength is evaluated with a pinchmeter in both hands. Prior to measurements, participants will be verbally informed and 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. The same process is repeated in the same way after the application and the values are noted.
Measured: one day
Jamar Hand Dynomometer
The grip strengths of all participants were in the standard position recommended by the "American Society of Hand Therapist" on both hands; Hand dynamometer is evaluated with elbow in 90° flexion, forearm and wrist in neutral position. When participants are ready, they will be asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Rest for 1 minute between measurements. The evaluation will be taken three times and the averages will be recorded as a result of the measurement. The same process is repeated in the same way after the application and the values are noted.
Measured: one day
Secondary outcomes (1)
Scoliometer
Bending the patient forward about 45 degrees is the angle at which the rotational deformity in the back region is best seen. The evaluation is completed by reading the degree of rotation of the curvature on the scoliometer according to the level where the curvature is highest.
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 posted5 Oct 2022
- Study start7 Oct 2022
- Primary completion8 Oct 2022
- Study completion2 Jan 2023
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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567302
- Sponsor's protocol ID
- Cervical Manual Therapy
- Status last verified
- Jan 2023
- First submitted
- 3 Oct 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.
PubMed 33090945
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT05567302
- Acronym / sponsor ID
- Cervical Manual Therapy
- Conditions
- Neck Pain
- Keywords
- manuel therapy, neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 5 Oct 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.
Chronic neck pain is an important health problem in modern society and is frequently encountered today. Approximately 10% of the adult population experiences neck pain at least once in their lives.
Anamnesis of the patient with neck pain; It should include the patient's complaints, illness history, family history, social status, work life and leisure activities.
The age of the patient, the severity of the symptoms, the mechanism of the injury, the activity history, the duration of the symptoms, the location and limits, the spread of the pain, the relationship of the complaints with the change in position, the restrictions during movement, and the sleeping positions should be taken into account. In addition, past diseases, operations and current diseases, medications used should be recorded.
Among chronic pains, neck pain ranks second after low back pain. Physical stresses in daily living activities, maintaining static posture and sleeping habits, carrying bags and weights in the wrong position, muscle imbalance are important factors in neck pain. Although cervical spine involvements have a great effect on neck pain, almost all of them have paravertebral muscle spasm, especially trapezius muscle spasm. Physiotherapy applications are widely used in the treatment of chronic neck pain.
Detailed description
Therapeutic approaches are frequently used to reduce inflammation and accelerate the healing process. Reducing pain in neck diseases, ensuring sufficient length of the muscle, strength balance, improving strength and function, improving postural re-education and cervical movements are the main goals. With the increasing prevalence of neck pain, the search for new treatment methods is increasing.
It includes manual therapy, manipulation, acupuncture, and soft tissue therapy for chronic neck pain. Neck pain results from deep muscle dysfunctions and altered fascia structures. In this case, it may cause the disruption of the continuous musculofacial corset-like system. In addition, changes in the fascia (increased fascial thickness and disruption of fascial alignment) may affect this system more. Myofascial release is one of the soft tissue treatment applications. Although there are studies reporting that myofascial release is a method that can achieve positive effects such as reducing pain intensity and improving muscle function, there are few studies on this subject in the literature and sufficient evidence has not been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Manual therapyManual therapy, manipulative therapy, is a completely manual treatment method that includes special techniques and is known as a treatment that aims to correct bony deformities and is highly effective when combined with exercise. |
| myofascial release | Active comparator | Other: myofascial releaseFoam rollers are a popular tool for helping athletes release muscle knots or trigger points.Myofascial release is a soft tissue method that provides removal of adhesions and tissue tension in tissues due to overload and repetitive use. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Neck pain
- Being between 20-60 years old
Key exclusion criteria (6 listed)
- Cardiopulmonary disease
- malignancy and pregnancy
- Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
- Spine surgery
- Psychological discomfort
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 therapyIn lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present. In lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present. A rotational maneuver will be performed from the posterior side of the articular pillar part of the superior vertebra, on the opposite side of the side where the movement restriction is present. | Other | Manual therapy |
| myofascial releaseThe soft tissue is palpated by the physiotherapist and pressure is applied directly to the skin until the tissue barrier is felt in the direction of restriction. Once the tissue barrier is present, it is applied for 90-120 seconds, without slipping on the skin or forcing the tissue, until the fascia complex begins to loosen and a softening sensation is achieved. | Other | myofascial release |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: one day
In the measurement of neck pain severity, a standard, proven reliability 10 mm VAS will be used. A value between 0 and 10 will be determined for the VAS, with 0 in the absence of pain and 10 mm in the most severe pain.
pinchmeter
Time frame: one day
Finger grip strength is evaluated with a pinchmeter in both hands. Prior to measurements, participants will be verbally informed and 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. The same process is repeated in the same way after the application and the values are noted.
Jamar Hand Dynomometer
Time frame: one day
The grip strengths of all participants were in the standard position recommended by the "American Society of Hand Therapist" on both hands; Hand dynamometer is evaluated with elbow in 90° flexion, forearm and wrist in neutral position. When participants are ready, they will be asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Rest for 1 minute between measurements. The evaluation will be taken three times and the averages will be recorded as a result of the measurement. The same process is repeated in the same way after the application and the values are noted.
1 secondary outcome
Scoliometer
Time frame: one day
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 4 Jan 2023.
- Background: PubMed 33090945Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.
- 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 Manual therapy and myofascial release in people with Neck Pain, run by Istanbul Medipol University Hospital 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 6 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 4 Jan 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?
Visual Analogue Scale (VAS) (time frame: one day). The study lists 3 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 NCT05567302, 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 4 Jan 2023.