Neck PainNCT05769179
Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain
A study testing Massage group, Connective tissue massage group and Mobilization group in people with Neck Pain, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Massage group, Connective tissue massage group and Mobilization group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-65.
- To participate in the study voluntarily.
- Having a complaint of neck pain for at least 3 months.
Who cannot join
- To have undergone cervical spine surgery
- Having cervical fracture and/or joint subluxation/dislocation
- Severe degenerative arthritis
- Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.)
- Presence of malignancy
- Having cord compression and signs
Show all 9Show fewer
- Severe radiculopathy or myelopathy
- Positive vertebrobasilar artery test,
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.
Read the detailed description
Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.
- Conditions
- Neck Pain
- Being tested
- Massage group, Connective tissue massage group, Mobilization group
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage groupOther
Massage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks
Connective tissue massage groupOther
Connective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks
Mobilization groupOther
Mobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | Massage group will be applied classic massage+cervical stabilisation exercises Receives: Other: Massage group |
| Connective tissue massage group | Experimental | Connective tissue group will be applied connective tissue massage+cervical stabilisation exercises Receives: Other: Connective tissue massage group |
| Mobilization group | Experimental | Mobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises Receives: Other: Mobilization group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain".
Measured: change from baseline at 4 weeks
Secondary outcomes (5)
Pressure Pain Threshold
Pressure Pain Threshold will be assessed with a digital algometer device. The device that objectively measures the pain threshold will be used for the evaluation. The probe of the device will be pressed on the trapezius muscle. The first pain threshold felt will be recorded.
Measured: change from baseline at 4 weeks
Cervical Range of Motion
Cervical range of motion will be evaluated with a goniometer in the sitting position. Neck flexion, extension, right-left lateral flexion and right-left rotation ranges of motion will be recorded
Measured: change from baseline at 4 weeks
Balance
Balance will be evaluated with the Biodex Balance System Device. The individual is placed on a platform of the device that evaluates the ability to keep the centre of gravity on the support surface. Changes in the centre of gravity of the individual standing on this platform will be recorded with this device in static and dynamic, with eyes open and closed.
Measured: change from baseline at 4 weeks
Functional Status
Functional Status will be assessed with Neck Disability Index. This index consists of 10 items. Each item was scored from 0 (no disability) to 5 (complete disability). The total score ranged from 0 (no disability) to 50 (total disability). As the score increased, disability increased and as the score decreased, disability decreased.
Measured: change from baseline at 4 weeks
Life quality
Life quality will be assessed with Short Form-36 questionnaire. The questionnaire consists of 36 items. Scoring is done over 100 points and the scores are between 0 and 100 points for each sub-parameter. "0" is calculated as the worst value and "100" as the best value.
Measured: change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
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.
- More trials run by Ankara Yildirim Beyazıt 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769179
- Sponsor's protocol ID
- 2023/03/03
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05769179
- Acronym / sponsor ID
- 2023/03/03
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 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.
The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.
Detailed description
Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: Massage groupMassage group will be applied classic massage+cervical stabilisation exercises |
| Connective tissue massage group | Experimental | Other: Connective tissue massage groupConnective tissue group will be applied connective tissue massage+cervical stabilisation exercises |
| Mobilization group | Experimental | Other: Mobilization groupMobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be between the ages of 18-65.
- To participate in the study voluntarily.
- Having a complaint of neck pain for at least 3 months.
Key exclusion criteria (9 listed)
- To have undergone cervical spine surgery
- Having cervical fracture and/or joint subluxation/dislocation
- Severe degenerative arthritis
- Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.)
- Presence of malignancy
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 |
|---|---|---|
| Massage groupMassage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks | Other | Massage group |
| Connective tissue massage groupConnective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks | Other | Connective tissue massage group |
| Mobilization groupMobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks | Other | Mobilization group |
Primary outcome
Pain Intensity
Time frame: change from baseline at 4 weeks
Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain".
5 secondary outcomes
Pressure Pain Threshold
Time frame: change from baseline at 4 weeks
Cervical Range of Motion
Time frame: change from baseline at 4 weeks
Balance
Time frame: change from baseline at 4 weeks
Functional Status
Time frame: change from baseline at 4 weeks
Life quality
Time frame: change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Massage group, Connective tissue massage group and Mobilization group in people with Neck Pain, run by Ankara Yildirim Beyazıt University.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: change from baseline at 4 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 15 Mar 2023.