Neck PainNCT02802189
The Effect of Integrated Neuromuscular Inhibition Technique in Combination With Therapeutic Exercise on Patients With Chronic Mechanical Neck Pain
A study testing Exercise programme and Integrated Neuromuscular Inhibition Technique application. in people with Neck Pain, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to examine the combine effect of the integrated neuromuscular inhibition technique (soft tissue mobilization techniques protocol), in combination with the therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of symptoms, and to determine whether this… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise programme and Integrated Neuromuscular Inhibition Technique application.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2016to Apr 2017
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 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
- Patients who are in the acute stage of symptoms
- Patients who have participated in any kind of treatment during the last three months (physiotherapy, massage, local injections of anesthetic blocks, etc.)
- Patients who have participated in an exercise program concerning their neck during the last six months
- Background of neck trauma and / or surgery in the neck region
- Inflammatory muscle diseases and joint infections, malignancy
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki
Thessaloniki, New Facilities, Thermi, Thessaloniki, 57001
About this study
The purpose of this study is to examine the combine effect of the integrated neuromuscular inhibition technique (soft tissue mobilization techniques protocol), in combination with the therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of symptoms, and to determine whether this combination substantially helps the faster and more efficient installation of adaptations of exercising.
Read the detailed description
Neck pain is one of the most common and costly musculoskeletal disorders in Western societies, which witnesses high prevalence of repeatability and chronicity. In chronic mechanical neck pain, there are changes in the neck area, due to muscular imbalance between deep neck flexors (longus capitis and longus colli) and superficial flexors of the neck (sternocleidomastoid and anterior scalene). Therapeutic exercise plays a key role in the restoration of this muscle imbalance, comprising a combination of resistant and endurance training. The integrated neuromuscular inhibition technique (INIT) is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.
The aim of the research is to investigate whether the application of INIT combined with exercise can reduce the time required to establish the benefits of training and improve faster and to a greater extent the clinical figure and the quality of life of patients with chronic neck pain.
Method. Single blind clinical trial lasting for 10 weeks, 40 participants (men/women) with chronic mechanical neck pain. Participants will be divided into two groups, following the same exercise program. The first group (experimental) will follow the exercise programme in combination with the integrated neuromuscular inhibition technique (INIT), while the second (active comparator) will apply the same program excluding the INIT technique. The subjective perception of pain by the visual analogue scale, the functionality related to neck pain with neck disability index, ppt of the neck muscles with pressure algometry, active range of motion with a bubble inclinometer, maximum isometric strength of neck muscles with a hand dynamometer, muscular fatigue of the flexors of the neck with special tests and the quality of life with the sf-36 questionnaire will be evaluated before, during and after the intervention, while follow-ups will take place one, three and six months later.
- Conditions
- Neck Pain
- Being tested
- Exercise programme, Integrated Neuromuscular Inhibition Technique application.
- Keywords
- Chronic Mechanical Neck Pain, exercise, Integrated Neuromuscular Inhibition Technique
- 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.
Exercise programmeOther
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
Integrated Neuromuscular Inhibition Technique application.Other
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
- Strain-counterstrain technique
| Study group | Role | What they receive |
|---|---|---|
| exercise and INIT group | Experimental | The first group (experimental) followed the exersice programme in combination with the integrated neuromuscular inhibition technique (INIT). Receives: Other: Exercise programme; Other: Integrated Neuromuscular Inhibition Technique application. |
| exercise group | Active comparator | The protocol for this group was identical to the previous group with the sole difference that the application of INIT was not included.
At the end of the exercise programme, relaxing breathing exercise and gentle stretching was applied for 15 min Receives: Other: Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective perception of neck pain with the visual analogue scale (VAS)
Pain intensity was assessed by the Visual Analog Pain Scale, which is a card with an uncalibrated scale ranging from zero to ten on the one side (with zero representing no pain and ten representing the worst pain in life) with each centimeter 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 ten. Then the exact value of pain intensity could be obtained with a single ruler. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
Measured: pre-treatment, Week: 2, 4, 6,10,14, 22, 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 Wagner algometer. For the procedure of PPT measurement, the protocol recommended by Fischer was applied (Fisher, 1998). 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.
Measured: pre-treatment, Week: 2, 4, 6, 10, 14, 22, 34
Changes in functional capacity with 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. The Greek version of the questionnaire was used for this study.
Measured: pre-treatment, Week 6, 10, 14, 22, 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 calibrated Manual Muscular Testing device with the participants in supine and prone position.
Measured: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Changes in Cervical Range of Motion with a bubble inclinometer
Cervical active range of motion was measured with a bubble inclinometer. Active cervical flexion, extension, and side bending range of motion were assessed gravity with Participants sitting in upright position.
Measured: pre-treatment, Week: 2, 4, 6,10,14, 22, 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. 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 (Chattanooga Stabilizer Pressure Biofeedback). While the test in the clinical setting provides only an indirect measure of performance, the construct validity of the CCFT has been verified in a laboratory setting by direct measurement of deep and superficial flexor muscle activity.
Measured: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Changes in isometric endurance capacity of sternocleidomastoid and anterior scalene, with a handheld stopwatch
The isometric endurance of the sternocleidomastoid and anterior scalene was assessed through 2 isometric contractions, one with no additional resistance and the other one with a kind of resistance corresponding to 30% of the maximum isometric strength. Participants were in supine position. A biofeedback device, provided the subject with motivation (auditory stimulus) encourage them to keep the contraction as long as possible. A 2-inch velcro band was secured around the forehead. The appropriate weight was suspended from the headband, and participants were asked to support the weight while maintaining a neutral head position for as long as possible. The endurance test was terminated when the position of the head changed (contact with table). Endurance time was measured using a handheld stopwatch.
Measured: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Secondary outcomes (1)
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.
Measured: pre-treatment, Week: 10, 14, 22, 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
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 Aristotle University Of ThessalonikiThe 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802189
- Sponsor's protocol ID
- AristotleU
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrated Neuromuscular Inhibition Technique in Combination With Therapeutic Exercise on Patients With Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02802189
- Acronym / sponsor ID
- AristotleU
- Conditions
- Neck Pain
- Keywords
- Chronic Mechanical Neck Pain, exercise, Integrated Neuromuscular Inhibition Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- 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 purpose of this study is to examine the combine effect of the integrated neuromuscular inhibition technique (soft tissue mobilization techniques protocol), in combination with the therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of symptoms, and to determine whether this combination substantially helps the faster and more efficient installation of adaptations of exercising.
Detailed description
Neck pain is one of the most common and costly musculoskeletal disorders in Western societies, which witnesses high prevalence of repeatability and chronicity. In chronic mechanical neck pain, there are changes in the neck area, due to muscular imbalance between deep neck flexors (longus capitis and longus colli) and superficial flexors of the neck (sternocleidomastoid and anterior scalene). Therapeutic exercise plays a key role in the restoration of this muscle imbalance, comprising a combination of resistant and endurance training. The integrated neuromuscular inhibition technique (INIT) is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.
The aim of the research is to investigate whether the application of INIT combined with exercise can reduce the time required to establish the benefits of training and improve faster and to a greater extent the clinical figure and the quality of life of patients with chronic neck pain.
Method. Single blind clinical trial lasting for 10 weeks, 40 participants (men/women) with chronic mechanical neck pain. Participants will be divided into two groups, following the same exercise program. The first group (experimental) will follow the exercise programme in combination with the integrated neuromuscular inhibition technique (INIT), while the second (active comparator) will apply the same program excluding the INIT technique. The subjective perception of pain by the visual analogue scale, the functionality related to neck pain with neck disability index, ppt of the neck muscles with pressure algometry, active range of motion with a bubble inclinometer, maximum isometric strength of neck muscles with a hand dynamometer, muscular fatigue of the flexors of the neck with special tests and the quality of life with the sf-36 questionnaire will be evaluated before, during and after the intervention, while follow-ups will take place one, three and six months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise and INIT group | Experimental | Other: Exercise programme, Other: Integrated Neuromuscular Inhibition Technique application.The first group (experimental) followed the exersice programme in combination with the integrated neuromuscular inhibition technique (INIT). |
| exercise group | Active comparator | Other: Exercise programmeThe protocol for this group was identical to the previous group with the sole difference that the application of INIT was not included. At the end of the exercise programme, relaxing breathing exercise and gentle stretching was applied for 15 min |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients 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)
- Patients who are in the acute stage of symptoms
- Patients who have participated in any kind of treatment during the last three months (physiotherapy, massage, local injections of anesthetic blocks, etc.)
- Patients who have participated in an exercise program concerning their neck during the last six months
- Background of neck trauma and / or surgery in the neck region
- Inflammatory muscle diseases and joint infections, 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 |
|---|---|---|
| Exercise programmeEndurance 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 | exercise and INIT group, exercise group |
| 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 * Strain-counterstrain technique | Other | exercise and INIT group |
Primary outcome
Changes in subjective perception of neck pain with the visual analogue scale (VAS)
Time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Pain intensity was assessed by the Visual Analog Pain Scale, which is a card with an uncalibrated scale ranging from zero to ten on the one side (with zero representing no pain and ten representing the worst pain in life) with each centimeter 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 ten. Then the exact value of pain intensity could be obtained with a single ruler. 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, 14, 22, 34
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a Wagner algometer. For the procedure of PPT measurement, the protocol recommended by Fischer was applied (Fisher, 1998). 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.
Changes in functional capacity with Neck disability index questionnaire
Time frame: pre-treatment, Week 6, 10, 14, 22, 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. The Greek version of the questionnaire was used for this study.
Changes in maximum isometric strength of neck muscles with Manual Muscular Testing
Time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Cervical flexion, extension, and side bending isometric strength were assessed using a calibrated Manual Muscular Testing device with the participants in supine and prone position.
Changes in Cervical Range of Motion with a bubble inclinometer
Time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
Cervical active range of motion was measured with a bubble inclinometer. Active cervical flexion, extension, and side bending range of motion were assessed gravity with Participants sitting in upright position.
Changes in deep flexors muscle endurance with craniocervical flexion test
Time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 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. 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 (Chattanooga Stabilizer Pressure Biofeedback). While the test in the clinical setting provides only an indirect measure of performance, the construct validity of the CCFT has been verified in a laboratory setting by direct measurement of deep and superficial flexor muscle activity.
Changes in isometric endurance capacity of sternocleidomastoid and anterior scalene, with a handheld stopwatch
Time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 34
The isometric endurance of the sternocleidomastoid and anterior scalene was assessed through 2 isometric contractions, one with no additional resistance and the other one with a kind of resistance corresponding to 30% of the maximum isometric strength. Participants were in supine position. A biofeedback device, provided the subject with motivation (auditory stimulus) encourage them to keep the contraction as long as possible. A 2-inch velcro band was secured around the forehead. The appropriate weight was suspended from the headband, and participants were asked to support the weight while maintaining a neutral head position for as long as possible. The endurance test was terminated when the position of the head changed (contact with table). Endurance time was measured using a handheld stopwatch.
1 secondary outcome
Changes in quality of life with the sort form of SF-36 Health Survey
Time frame: pre-treatment, Week: 10, 14, 22, 34
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 28 Jun 2017.
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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 Exercise programme and Integrated Neuromuscular Inhibition Technique application. in people with Neck Pain, run by Aristotle University Of Thessaloniki at 1 site 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 28 Jun 2017. 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 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. 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 subjective perception of neck pain with the visual analogue scale (VAS) (time frame: pre-treatment, Week: 2, 4, 6,10,14, 22, 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 28 Jun 2017.