Neck PainNCT05154526
Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain
A study testing Manual Therapy and Exercise Program in people with Neck Pain and Mobility Limitation, run by Tuğba Akgüller at 1 site in Turkey (Türkiye).
Trial summary
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neck Pain, Mobility Limitation
- What is being tested?
- Manual Therapy and Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2021to 19 Apr 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with MNP
- Decrease in cervical region ROM
- Ability to adapt to verbal, written and visual instructions
Who cannot join
- Spine surgery history
- Neurological neck pain in the cervical region
- Presence of tumor in the cervical region
- Blood coagulation disorders
- Vertebrobasilar artery insufficiency
- Cervical region trauma history
Show all 9Show fewer
- Communicative/mental problems that prevent participation in treatment
- Inflammatory rheumatological diseases affecting the cervical region
- Physiotherapy and rehabilitation treatments for neck pain in the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
About this study
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
Read the detailed description
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. MNP causes symptoms such as pain in the cervical region, increased sensitivity to pressure, decrease in active range of motion (ROM) of the cervical region, drowsiness, and dizziness. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. When the current treatment recommendations are examined according to the duration of neck pain accompanied by limitation of movement, an exercise program that includes thoracic region mobilization, cervical ROM exercises, and strengthening and stretching exercises for the scapulothoracic region and upper extremity muscles is recommended for acute neck pain. In addition, various manual therapy techniques can be applied to the cervical region.
In subacute neck pain, an exercise program is applied to increase the endurance of the neck and upper extremity muscles. During this period, various manual therapy methods can be applied to the thoracic and cervical region. In chronic neck pain, combined treatment applications including various exercises, mobilization and manipulation techniques, dry needling, laser and intermittent manual/mechanical traction are recommended. It is stated that the high-velocity low-amplitude technique, which is among the manual therapy techniques and used in many musculoskeletal problems, can increase the ROM, decrease the pain and improve the function.
Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
- Conditions
- Neck Pain, Mobility Limitation
- Being tested
- Manual Therapy, Exercise Program
- Keywords
- neck pain, mechanical neck pain, manual therapy, exercise
- Medical subject headings
- Neck Pain, Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Manual Therapy: High velocity-low amplitude technique
Exercise ProgramOther
Exercise program
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Exercise Program only Receives: Other: Exercise Program |
| Manual Therapy Group | Active comparator | Manual Therapy only Receives: Other: Manual Therapy |
| Manual Therapy and Exercise Group | Active comparator | Manual Therapy + exercise program Receives: Other: Manual Therapy; Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).
Measured: 6 weeks
Pain intensity
Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
Measured: 6 weeks
Secondary outcomes (4)
Range of Motion (ROM)
Active neck flexion-extension, right-left lateral flexion and right-left rotation ROM of the participants will be evaluated with cervical goniometer.
Measured: 6 weeks
Pain Pressure Threshold (PPT)
Participants' PPTs will be evaluated with a pressure algometer (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) that can measure pressure in kilograms and pounds, with a 1 cm diameter circular rubber tip attached to the piston of the pressure gauge
Measured: 6 weeks l
36-Item Short Form Survey (SF-36)
Patients' quality of life will be evaluated with SF-36. This scale is a general health questionnaire that evaluates the person's perception of quality of life in the last four weeks under 8 sub-headings and 36 items. The sub-headings it includes; physical functions, physical roles, pain, social functions, mental health, emotional roles, energy and general health perception.
Measured: 6 weeks
Patient satisfaction level
Patient Satisfaction will be assessed with the Global Rating of Change (GRC) scale. The scale to be used consists of 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
Measured: At the end of 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start13 Dec 2021
- Primary completion19 Apr 2022
- Study completion19 Apr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Akgüller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Akgüller, Istanbul Arel University
- Investigators
- Yıldız Analay Akbaba, PhD, Study director, Istabul University-Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154526
- Sponsor's protocol ID
- Istanbul University Cerrahpasa
- Status last verified
- May 2023
- First submitted
- 13 Nov 2021
- Last updated
- 26 May 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05154526
- Acronym / sponsor ID
- Istanbul University Cerrahpasa
- Conditions
- Neck Pain, Mobility Limitation
- Keywords
- neck pain, mechanical neck pain, manual therapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tuğba AkgüllerUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 13 Dec 2021 (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.
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
Detailed description
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. MNP causes symptoms such as pain in the cervical region, increased sensitivity to pressure, decrease in active range of motion (ROM) of the cervical region, drowsiness, and dizziness. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. When the current treatment recommendations are examined according to the duration of neck pain accompanied by limitation of movement, an exercise program that includes thoracic region mobilization, cervical ROM exercises, and strengthening and stretching exercises for the scapulothoracic region and upper extremity muscles is recommended for acute neck pain. In addition, various manual therapy techniques can be applied to the cervical region.
In subacute neck pain, an exercise program is applied to increase the endurance of the neck and upper extremity muscles. During this period, various manual therapy methods can be applied to the thoracic and cervical region. In chronic neck pain, combined treatment applications including various exercises, mobilization and manipulation techniques, dry needling, laser and intermittent manual/mechanical traction are recommended. It is stated that the high-velocity low-amplitude technique, which is among the manual therapy techniques and used in many musculoskeletal problems, can increase the ROM, decrease the pain and improve the function.
Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise ProgramExercise Program only |
| Manual Therapy Group | Active comparator | Other: Manual TherapyManual Therapy only |
| Manual Therapy and Exercise Group | Active comparator | Other: Manual Therapy, Other: Exercise ProgramManual Therapy + exercise program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with MNP
- Decrease in cervical region ROM
- Ability to adapt to verbal, written and visual instructions
Key exclusion criteria (9 listed)
- Spine surgery history
- Neurological neck pain in the cervical region
- Presence of tumor in the cervical region
- Blood coagulation disorders
- Vertebrobasilar artery insufficiency
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 TherapyManual Therapy: High velocity-low amplitude technique | Other | Manual Therapy Group, Manual Therapy and Exercise Group |
| Exercise ProgramExercise program | Other | Exercise Group, Manual Therapy and Exercise Group |
Primary outcome
Neck Disability Index
Time frame: 6 weeks
The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).
Pain intensity
Time frame: 6 weeks
Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
4 secondary outcomes
Range of Motion (ROM)
Time frame: 6 weeks
Pain Pressure Threshold (PPT)
Time frame: 6 weeks l
36-Item Short Form Survey (SF-36)
Time frame: 6 weeks
Patient satisfaction level
Time frame: At the end of 6-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 26 May 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.
Yıldız Analay Akbaba, PhD study director
Istabul University-Cerrahpasa
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 Exercise Program in people with Neck Pain and Mobility Limitation, run by Tuğba Akgüller 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 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: finished, as of the sponsor's last update on 26 May 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?
Neck Disability Index (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 26 May 2023.