Neck PainNCT04327739
Adding Two Different Types of Manual Techniques to an Exercise Program for the Management of Chronic Neck Pain
A study testing Intervention 1 Exercise, Intervention 2 Exercise and INIT and Intervention 3 Exercise and SMT in people with Neck Pain, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Intervention 1 Exercise, Intervention 2 Exercise and INIT and Intervention 3 Exercise and SMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 30 Jun 2020to 30 Jun 2021
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with chronic neck pain with a duration of symptoms for at least three months
- Existence of at least one active or latent trigger point in any of the muscles: levator scapulae, upper trapezoid, and splenius capitis
- Patients whose neck pain has emerged as a result of a specific pathology, confirmed by radio-diagnostic tests (X-ray or MRI)
- Patients with a medical referral for physical therapy with the etiology of neck pain
Who cannot join
- Included the acute stage of symptoms confirmed by visual analog scale (VAS; score >70 mm)
- Participation in any kind of treatment during the past 3 months (e.g., physiotherapy, massage, local injections of anesthetic blocks)
- Participation in an exercise program concerning the neck muscles during the past 6 months
- Background of neck trauma and/or surgery in the neck region
- Inflammatory muscle diseases, joint infections, and malignancy.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Aristotle University of Thessaloniki
Thessaloniki, Central Makedonia, 57001
Department of Physical Education and Sports Sciences
Thessaloniki, Thermi, 57001
About this study
Official title: Effects of Adding Two Different Types of Manual Techniques to a Therapeutic Exercise Program for the Management of Chronic Neck Pain: A Randomized Controlled Trial of Comparative Effectiveness
Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.
The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.
An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.
Read the detailed description
Background Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.
Aim The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.
Method An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.
- Conditions
- Neck Pain
- Being tested
- Intervention 1 Exercise, Intervention 2 Exercise and INIT, Intervention 3 Exercise and SMT, Control
- Keywords
- Chronic Neck Pain, Exercise, Manual techniques, Spinal manipulation, Integrated neuromuscular inhibition technique, Rehabilitation
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 ExerciseOther
- Exercise programme Endurance and Resistant training exercise program (Duration: 45 minutes) • Muscle retraining of longus colli and endurance training of the deep cervical flexors. • Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM). • Active ROM exercises for the neck muscles • Upper limbs exercises with resistant bands • Stretching exercises for the neck and upper limbs muscles
Intervention 2 Exercise and INITOther
- Exercise programme same as Intervention Group 1 and
- Integrated Neuromuscular Inhibition Technique application. Integrated Neuromuscular Inhibition Technique application. (Duration: 15min) The protocol was applied to the following muscles: • Upper border of the trapezius muscle • sternocleidomastoid • levator scapulae muscle • splenius capitis muscle Integrated Neuromuscular Inhibition Technique includes the combination of the following technique: • Ischemic compression • Muscle energy technique • Straincounterstrain technique
Intervention 3 Exercise and SMTOther
- Exercise programme same as Intervention Group 1 and
- Manipulation Care. Participants allocated to this group received Spinal Manipulation Therapy after the therapeutic exercise programme. Treatment was delivered by 1 chiropractor with a minimum 5-year experience of clinical practice. Pain provocation and static/motion palpation findings were used to determine areas of treatment in the cervical spine. The Manipulation Therapy technique included joint motion using a diversified thrust technique, and mobilization, a low-velocity type of joint oscillation. The type and the force of the applied spinal manipulation were individualized according to the age and physical condition of each participant. Soft passive stretching, light massage and hot packs were applied to the cervical and upper thoracic area before manipulation in order to prepare each participant.
ControlOther
Participants allocated to this group received general consulting istructions and a home based general exercise sheet
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 Exercise | Experimental | Participants allocated to this group received a 10 weeks exercise programme for neck and upper limbs muscles Receives: Other: Intervention 1 Exercise |
| Intervention 2 Exercise and INIT | Experimental | Participants allocated to this group received the same exercise programme as group 1 in combination with the integrated neuromuscular inhibition technique (INIT) Receives: Other: Intervention 2 Exercise and INIT |
| Intervention 3 Exercise and SMT | Experimental | Participants allocated to this group received the same exercise programme as group 1 in combination with cervical manipulation Receives: Other: Intervention 3 Exercise and SMT |
| Control | Placebo comparator | Participants allocated to this group received general consulting instructions and a home based general exercise sheet Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain intensity with visual analogue scale (VAS)
VAS is a card with an uncalibrated scale ranging from 0-100 mm on the one side (with zero representing no pain and 100 representing the worst pain in life) with each millimeter representing one pain level. The patient subjectively estimated his or her pain level by marking a vertical line on the uncalibrated scale between zero and one hundred. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
Measured: pre-treatment, Week: 2, 4, 6,10, 34
Changes in Pressure Pain threshold with pressure algometry
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion, the levator scapulae muscle 2 cm above the lower insertion located in the upper medial border of the scapulae, Sternocleidomastoid muscle and to splenius capitis 2 cm lateral to the spinous processus of the axis. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.
Measured: pre-treatment, Week: 2, 4, 6, 10, 34
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.
Measured: pre-treatment, Week 6, 10, 34
Changes in maximum isometric strength of neck muscles with Manual Muscular Testing
Cervical flexion, extension, and side bending isometric strength were assessed using a Manual Muscular Testing device with the participants in supine and prone position. Isometric strength were assessed in kg.
Measured: pre-treatment, Week: 2, 4, 6, 10, 34
Changes in Cervical Range of Motion with bubble inclinometers
Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees
Measured: pre-treatment, Week: 2, 4, 6, 10, 34
Changes in deep flexors muscle endurance with craniocervical flexion test
The craniocervical flexion test (CCFT) is a clinical test of the anatomical action of the deep cervical flexor muscles, (longus capitis, and longus colli). It could be described as a test of neuromotor control. It includes the performance of five progressive stages of increasing craniocervical flexion range of motion (22, 24, 26, 28, and 30 mm Hg). It is a low-load test performed in the supine position with the patient guided to each stage by feedback from a pressure sensor placed behind the neck. While the test in the clinical setting provides only an indirect measure of performance.
Measured: pre-treatment, Week: 2, 4, 6, 10, 34
Changes in quality of life with the sort form of SF-36 Health Survey
For the evaluation of the intervention in the quality of life of the participants the short form of SF-36 Health Survey questionnaire was used. SF-36 consists of 36 questions, selected from the Medical Outcomes Study (MOS), which relate to eight different parameters of mental and physical health. Total Physical and Mental Health, as well as the subcategory of Bodily Pain were evaluated in this study
Measured: pre-treatment, Week: 10, 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start30 Jun 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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
- Model description
- An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LYTRAS DIMITRIOS, Aristotle University Of Thessaloniki
- Investigators
- Evaggelos Sykaras, PT, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327739
- Sponsor's protocol ID
- 256445/2019
- Status last verified
- Jul 2021
- First submitted
- 27 Mar 2020
- Last updated
- 22 Jul 2021
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Two Different Types of Manual Techniques to a Therapeutic Exercise Program for the Management of Chronic Neck Pain: A Randomized Controlled Trial of Comparative Effectiveness
- ClinicalTrials.gov ID
- NCT04327739
- Acronym / sponsor ID
- 256445/2019
- Conditions
- Neck Pain
- Keywords
- Chronic Neck Pain, Exercise, Manual techniques, Spinal manipulation, Integrated neuromuscular inhibition technique, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 Mar 2020 (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.
Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.
The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.
An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.
Detailed description
Background Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.
Aim The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.
Method An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 Exercise | Experimental | Other: Intervention 1 ExerciseParticipants allocated to this group received a 10 weeks exercise programme for neck and upper limbs muscles |
| Intervention 2 Exercise and INIT | Experimental | Other: Intervention 2 Exercise and INITParticipants allocated to this group received the same exercise programme as group 1 in combination with the integrated neuromuscular inhibition technique (INIT) |
| Intervention 3 Exercise and SMT | Experimental | Other: Intervention 3 Exercise and SMTParticipants allocated to this group received the same exercise programme as group 1 in combination with cervical manipulation |
| Control | Placebo comparator | Other: ControlParticipants allocated to this group received general consulting instructions and a home based general exercise sheet |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with chronic neck pain with a duration of symptoms for at least three months
- Existence of at least one active or latent trigger point in any of the muscles: levator scapulae, upper trapezoid, and splenius capitis
- Patients whose neck pain has emerged as a result of a specific pathology, confirmed by radio-diagnostic tests (X-ray or MRI)
- Patients with a medical referral for physical therapy with the etiology of neck pain
Key exclusion criteria (5 listed)
- Included the acute stage of symptoms confirmed by visual analog scale (VAS; score >70 mm)
- Participation in any kind of treatment during the past 3 months (e.g., physiotherapy, massage, local injections of anesthetic blocks)
- Participation in an exercise program concerning the neck muscles during the past 6 months
- Background of neck trauma and/or surgery in the neck region
- Inflammatory muscle diseases, joint infections, and 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 |
|---|---|---|
| Intervention 1 Exercise• Exercise programme Endurance and Resistant training exercise program (Duration: 45 minutes) • Muscle retraining of longus colli and endurance training of the deep cervical flexors. • Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM). • Active ROM exercises for the neck muscles • Upper limbs exercises with resistant bands • Stretching exercises for the neck and upper limbs muscles | Other | Intervention 1 Exercise |
| Intervention 2 Exercise and INIT* Exercise programme same as Intervention Group 1 and * Integrated Neuromuscular Inhibition Technique application. Integrated Neuromuscular Inhibition Technique application. (Duration: 15min) The protocol was applied to the following muscles: • Upper border of the trapezius muscle • sternocleidomastoid • levator scapulae muscle • splenius capitis muscle Integrated Neuromuscular Inhibition Technique includes the combination of the following technique: • Ischemic compression • Muscle energy technique • Straincounterstrain technique | Other | Intervention 2 Exercise and INIT |
| Intervention 3 Exercise and SMT* Exercise programme same as Intervention Group 1 and * Manipulation Care. Participants allocated to this group received Spinal Manipulation Therapy after the therapeutic exercise programme. Treatment was delivered by 1 chiropractor with a minimum 5-year experience of clinical practice. Pain provocation and static/motion palpation findings were used to determine areas of treatment in the cervical spine. The Manipulation Therapy technique included joint motion using a diversified thrust technique, and mobilization, a low-velocity type of joint oscillation. The type and the force of the applied spinal manipulation were individualized according to the age and physical condition of each participant. Soft passive stretching, light massage and hot packs were applied to the cervical and upper thoracic area before manipulation in order to prepare each participant. | Other | Intervention 3 Exercise and SMT |
| ControlParticipants allocated to this group received general consulting istructions and a home based general exercise sheet | Other | Control |
Primary outcome
Changes in neck pain intensity with visual analogue scale (VAS)
Time frame: pre-treatment, Week: 2, 4, 6,10, 34
VAS is a card with an uncalibrated scale ranging from 0-100 mm on the one side (with zero representing no pain and 100 representing the worst pain in life) with each millimeter representing one pain level. The patient subjectively estimated his or her pain level by marking a vertical line on the uncalibrated scale between zero and one hundred. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
Changes in Pressure Pain threshold with pressure algometry
Time frame: pre-treatment, Week: 2, 4, 6, 10, 34
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion, the levator scapulae muscle 2 cm above the lower insertion located in the upper medial border of the scapulae, Sternocleidomastoid muscle and to splenius capitis 2 cm lateral to the spinous processus of the axis. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Time frame: pre-treatment, Week 6, 10, 34
It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.
Changes in maximum isometric strength of neck muscles with Manual Muscular Testing
Time frame: pre-treatment, Week: 2, 4, 6, 10, 34
Cervical flexion, extension, and side bending isometric strength were assessed using a Manual Muscular Testing device with the participants in supine and prone position. Isometric strength were assessed in kg.
Changes in Cervical Range of Motion with bubble inclinometers
Time frame: pre-treatment, Week: 2, 4, 6, 10, 34
Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees
Changes in deep flexors muscle endurance with craniocervical flexion test
Time frame: pre-treatment, Week: 2, 4, 6, 10, 34
The craniocervical flexion test (CCFT) is a clinical test of the anatomical action of the deep cervical flexor muscles, (longus capitis, and longus colli). It could be described as a test of neuromotor control. It includes the performance of five progressive stages of increasing craniocervical flexion range of motion (22, 24, 26, 28, and 30 mm Hg). It is a low-load test performed in the supine position with the patient guided to each stage by feedback from a pressure sensor placed behind the neck. While the test in the clinical setting provides only an indirect measure of performance.
Changes in quality of life with the sort form of SF-36 Health Survey
Time frame: pre-treatment, Week: 10, 34
For the evaluation of the intervention in the quality of life of the participants the short form of SF-36 Health Survey questionnaire was used. SF-36 consists of 36 questions, selected from the Medical Outcomes Study (MOS), which relate to eight different parameters of mental and physical health. Total Physical and Mental Health, as well as the subcategory of Bodily Pain were evaluated in this study
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 22 Jul 2021.
- 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.
Evaggelos Sykaras, PT, PhD study director
Aristotle University Of Thessaloniki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 Exercise, Intervention 2 Exercise and INIT and Intervention 3 Exercise and SMT in people with Neck Pain, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 4 inclusion and 5 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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. Some participants in this study may receive a placebo. 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?
Changes in neck pain intensity with visual analogue scale (VAS) (time frame: pre-treatment, Week: 2, 4, 6,10, 34). The study lists 7 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 22 Jul 2021.