Neck PainNCT05447338
Manual Therapy in Patients With Neck Pain
A study testing Specific joint mobilization post muscle inhibition on C1, Maitland C2 and SNAG C1 in people with Neck Pain, run by Universidad Nacional de Córdoba at 1 site in Argentina.
Trial summary
Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Specific joint mobilization post muscle inhibition on C1, Maitland C2 and SNAG C1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteArgentina
- Study dates
- 30 Aug 2021to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- You must have a medical indication for cervical physiotherapy.
- Must present decreased ROM of the upper cervical spine assessed with CRFT, either acute or subacute and of a mechanical type or PN and grade I and II of severity according to The Neck Pain Task Force.
Who cannot join
- Joint instability, dislocations, fractures or stenosis of the cervical spinal canal.
- Malformations and/or bony alterations of the cervical spine or the brain.
- Head injury or whiplash in the last 10 years. Infections, unhealed wounds, tumors, vascular pathology or cancer that compromises the cervical spine and/or the brain.
- Being under treatment with anti-inflammatories, muscle relaxants or some type of pain reliever.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Conci Carpinella
Córdoba, 5000
Verónica Schmidt, 3515111927, asistenteadp@concicarpinella.com.ar
Cecilia Pérez, 3512271419, cmintegral@concicarpinella.com
About this study
Official title: Effectiveness of Post Muscle Inhibition Specific Joint Mobilization on Range of Motion and Pain in Patients With Mechanical Neck Pain
Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. An important finding is that approximately 60% of total cervical rotation takes place at C1-C2, regardless of age. The test used to diagnose dysfunction of the upper cervical spine is the Cervical Rotation Flexion Test (CRFT) and is measured in degrees through various instruments, the most current validated by scientific literature are mobile applications (Clinometer and Compass ). Having in clear the importance of the location (C1-C2) of the origin of many of the symptoms and signs that cervicalgia generates and mainly the restriction of the range of movement that they produce in the cervical spine. It is that the manual therapy technique: Joint mobilization post muscular inhibition (MAEPI) that is included in this study for its analysis, is directed to this segment of the cervical spine. This differs from other similar techniques, in terms of location and movement of the joint surfaces, which have been previously studied and have shown their effectiveness (techniques that will be used in the control group), in that the micro movements of the joint surfaces ( joint arthrokinematics) based on the principles of Kaltenborn-Evjenth will be combined with the principles of the hold relax technique belonging to the Proprioceptive Neuromuscular Facilitation method. The main therapeutic objective of the MAEPI technique is to improve mobility and reduce pain in the cervical spine.
Hypothesis: The MAEPI technique will improve mobility and reduce neck pain as well as other symptoms associated with neck pain, such as headache, dizziness and nausea, and will be more effective than those of the control group (Maitland central posterior-anterior passive joint mobilization in C2 and natural apophyseal slippage sustained (SNAG) in rotation about Mulligan's C1). The MAEPI technique will be more effective when applied later to myofascial induction techniques.
Read the detailed description
Main goal
-Determine the effectiveness of the MAEPI applied on C1-C2 on the improvement of the range of motion and pain in patients with mechanical neck pain. As well as its effectiveness after performing myofascial induction techniques.
Specific objectives
- Identify the disability index, the intensity of the pain and the degree of mobility of the patients before and after the application of the proposed treatment protocols.
- Identify other symptoms associated with neck pain, such as dizziness, headache and nausea before and after the application of treatment protocols.
- Establish whether there are significant differences in terms of ROM between the proposed protocols, taking into account age, sex, work activity of individuals with neck pain in relation to evolution.
Sample size: The sample size estimate was based on data from previous studies. The standard deviation of 11.1º of the range of motion of the average of the CRFT measurements in patients with upper cervical dysfunction was used. The calculation was performed using the GRANMO sample size calculator (version 7). For an analysis of variance, accepting an alpha risk of 0.05 and a beta risk of less than 0.2 in a unilateral contrast, 38 subjects are needed in each group to detect a minimum difference of 8º between two groups, assuming that there are 3 groups and a deviation 11.1º standard. A rate of loss to follow-up of 10% has been estimated. In the case of repeated paired means by group (experimental group A, MAEPI), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 16 subjects are required to detect a difference equal to or greater than 8 degrees. A standard deviation of 11.1 is assumed. A rate of loss to follow-up of 0% has been estimated.
Data analysis: The InfoStat program will be used. The data will be analyzed according to the nature of each variable in the ANAVA study, non-linear regression, categorical, correlational data and multiple comparisons test (Fisher's test), establishing significant differences when p<0.05 for all cases. The variables dizziness, headache and nausea: they will be evaluated using a qualitative table and later they will be compared using the Chi square test. In the experimental group A: MAEPI, the t test will be performed for paired data (before and after, for the intervention group of the technique alone).
Expected results
Regarding therapeutic effects, it is expected that:
- Experimental Group A is superior to the Control Group.
- Experimental Group B is superior to Experimental Group A.
- Conditions
- Neck Pain
- Being tested
- Specific joint mobilization post muscle inhibition on C1, Maitland C2, SNAG C1, Specific joint mobilization post muscle inhibition on C2, Myofascial inductions; Suboccipital induction
- Keywords
- Neck Pain, Rehabilitation, Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific joint mobilization post muscle inhibition on C1Procedure or surgery
Grasp the hand with the thumb or forefinger at the spinous process of C1. The contratoma hand is placed in forceps with the thumb and forefinger on the patient's temple, one on each side. Resisting with the hand on the temple, the therapist asks the patient to perform a 6-second isometric contraction of the cervical spine flexor muscles. The therapist then instructs the patient to relax the musculature and simultaneously performs posteroanterior pressure on the spinous process of C2 and passive extension of the head (with the hand on the temple). The maneuver is repeated until the therapist notices the release in the flexion-extension movement of the head.
Maitland C2Procedure or surgery
Maitland central posterior-anterior passive joint mobilization at C2: The patient will lie prone, the therapist behind the patient's head, with both thumbs will apply a central force on the spinous process of C2. The duration of the application will be up to five applications of 10 to 30 seconds in duration, depending on clinical judgment.
SNAG C1Procedure or surgery
Sustained natural apophyseal slippage (SNAG) will be applied e.g. in the case of wanting to improve the left rotation. The therapist performs a sustained anterior glide to the C1 transverse process on the left. The participant will be seated, simultaneously rotating their head to the left while holding the SNAG. The glide of C1 will be maintained by the therapist until the participant's head returns to the neutral starting position. The same will be done, but in the opposite direction to improve the right rotation.
Specific joint mobilization post muscle inhibition on C2Procedure or surgery
The therapist rotates the head to the right side until the final sensation of the movement is noted, either due to pain or muscular tension. From this position, the therapist asks the patient to rotate the head to the left side while offering resistance with both hands in the opposite direction, in such a way as to generate an isometric contraction of the rotator muscles of the head to the left. The therapist then asks the patient to hold the position for 6 seconds. Subsequently, the therapist with the finger in the transverse process of C1, pushes it in the postero-anterior direction and simultaneously (with the contratome hand) rotates the patient's head to the right. The technique is repeated until the ROM improves, always taking into account the patient's tolerance.
Myofascial inductions; Suboccipital inductionProcedure or surgery
The therapist places his hands under the patient's head in such a way that he can palpate the spinous processes of the cervical vertebrae with his fingers. Next, slowly bring your fingers up until they contact the occipital condyles. At this time he should gently move his fingers downward, thus finding the space between the condyles and the spinous process of the axis. Next, flexing the metacarpophalangeal joints to 90°, slowly elevate the skull. The therapist's hands should remain together and the base of the skull should rest on their palms. The therapist should apply pressure with the index, middle and ring fingers of each hand. This pressure should be maintained for a few minutes until a release of the fascia is noted. In the last phase of the technique, the therapist, without releasing the pressure, opens his hands and slowly brings his head back.
Myofascial inductions; Synchronization of the temporal bones PHASE 1Procedure or surgery
The therapist rests his two forearms on the table, in such a way that he can contact the external auditory canal with his middle fingers. Place the ring fingers on the mastoid processes and the index fingers on the zygomatic arches. Subsequently, a rotary movement is made on the axis marked by the line that joins the middle fingers. With one of the hands, the movement is in the direction of movement clockwise, and with the other hand, simultaneously, in the opposite direction. By obtaining a symmetry in the movement in opposite directions, the movement is made in the same direction with both hands, first forwards and then backwards. Note how the ring fingers rotate first backwards and then upwards. Symmetry in movements should also be sought
Myofascial inductions; Horizontal induction of the TMJ.Procedure or surgery
The therapist places the middle fingers of both hands on the lingual aspect of the lower molar teeth and then gently presses towards the table. This pressure must be maintained for a minimum of 90 to 120 seconds. Afterwards, the therapist, very attentive to the changes in the direction of the fascial restriction, follows the release movement.
Myofascial inductions; Posterior elongation of the cervical fascia in the supine positionProcedure or surgery
Position of the patient, lying on the stretcher in the supine position. Therapist position: Sitting at the head of the table. Technique: With one of his hands, the therapist supports the patient's head on the occipital area and slowly brings it to flexo-elevation. With the other hand, he contacts the mass of the paravertebral muscles, placing the thumb on one side of the spine and the proximal interphalangeal joint of the index finger in flexion on the other. While one hand holds the head position, the other performs a downward vertical slide. The maneuver is repeated between 3 and 7 times in a slow and progressive manner.
Myofascial induction; Angle of the scapulaProcedure or surgery
Position of the patient, supine position, with the arm resting along the trunk. Position of the therapist, standing or sitting at the head of the table. The therapist places one of his hands under the shoulder blade, embracing the lower angle with the fingertips and bringing it slightly cranially. This maneuver frees access to the superior angle of the scapula, which makes it easier for the index and middle fingers of the other hand to contact the insertion of the angle. More sustained pressure is applied to this point, while the hand placed on the scapula moves in the direction of release.
Myofascial induction sternocleidomastoid musclesProcedure or surgery
Objective, release the myofascial restrictions of the fascia of the SCM muscle. Position of the patient, supine position with the head near the upper edge of the stretcher. Therapist position. sitting at the head of the stretcher. Technique: The therapist, with one hand placed on the occipital region, gently rotates the patient's head. The other hand places it on the mass of the SCM muscle with the thumb at the point of insertion on the mastoid process. While one hand applies the rotational movement and a slight extension of the head, the other performs a transverse slide over the zone of restriction in the SCM muscle. A longitudinal sliding movement of the SCM muscle can be made between the thumb and forefinger of the executing hand.
Myofascial induction of pectoralis major and minorProcedure or surgery
Objective, release the fascia of the pectoralis major and minor muscle. Position of the patient, supine position, with the arm abducted to about 120 degrees. Position of the therapist, standing next to the patient, at head height. Technique: with his cranial hand, the therapist holds the patient's arm, and with the caudal hand, placed in a prone position, contacts the space between pectoralis major and ribs. This contact is made with the fingertips. The pressure should be maintained for about 5 minutes. As the release occurs, both of the therapist's hands must adjust to the direction of the changes. When detecting the restriction in the pectoralis minor, the penetration should be deepened with the hand, sliding it over the ribs. Contact and restraints with the pectoralis minor and major are often particularly painful, forcing the therapist to apply controlled force.
Myofascial induction; upper trapeziusProcedure or surgery
Objective, release the myofascial restrictions of the upper trapezius. Position of the patient, supine, with the elbow flexed and the hand resting on the abdomen, and the arm in a slight abduction. Therapist position, sitting at the head of the table. Technique: The therapist places his hand on the patient's shoulder so that he can grasp the fibers of the upper trapezius between the index, middle, and ring fingers above and the thumb below. Subsequently, he exerts gentle and sustained pressure overcoming three restraining barriers.
Myofascial induction, of the fascia of the subscapularis muscleProcedure or surgery
Position of the patient, supine, with the arm raised about 90-160 degrees, depending on the degree of movement restriction. Therapist position, standing at the head of the table. Phase A With his cranial hand, the therapist holds the patient's arm and performs very gentle traction. The palm of the caudal hand, thumb up, is placed on the outer edge of the scapula, as close as possible to the glenohumeral joint. A slight traction is performed with both hands in opposite directions, subsequently following the direction of release. Phase B, The thumb of the caudal hand slightly invades the space between the inner aspect of the scapula and the thorax. The rest of the application is performed as in phase A. Phase C, the therapist places his caudal hand in a prone position and slowly penetrates the aforementioned space with the tips of the fingers. sustained for a time ranging between 90 seconds and 5 minutes, following the release stages.
Intraoral myofascial induction of the masseterProcedure or surgery
Position of the patient, supine position, on the stretcher without the pillow. Position of the therapist, sitting at the head of the table. Technique: The therapist, with the index of his hand, contacts the masseter just below the zygomatic arch and inside the mouth. To ensure proper contact on the masseter, the patient is asked to attempt to close the mouth. Once the muscle is correctly located, the patient should immediately relax the masseter. Next, the therapist compresses the masseter between his index finger and thumb. You have to wait long enough for the release to occur. Sometimes both hands are used by placing the forefinger of the other hand on the outer surface.
Deep myofascial induction of the external pterygoidProcedure or surgery
Objective, release the myofascial restrictions and recover the functional coordination of the external pterygoid muscles.
Position of the patient, supine position, on the stretcher without the pillow. Therapist position, sitting at the head of the table. Technique: The therapist palpates the temporomandibular joint with the index or middle finger of one hand. With the index finger of the other hand, he contacts the pterygoid inside the mouth and maintains pressure until release occurs.
Intraoral mifascial induction of the internal pterygoidProcedure or surgery
Objective, release the restrictions of the internal pterygoid fascia. Position of the patient, supine position on the stretcher. Therapist position, sitting laterally at the head of the stretcher and looking at the patient. Technique: Therapist palpates the TMJ with the index or middle finger of one hand. With the index of the other hand, he contacts the pterygoid inside the mouth and maintains pressure until release occurs. You have to wait three consecutive releases.
Myofascial inductions; Synchronization of the temporal bones PHASE 2Procedure or surgery
The therapist rests his two forearms on the table, in such a way that he can contact the external auditory canal with his middle fingers. Place the ring fingers on the mastoid processes and the index fingers on the zygomatic arches. Subsequently, a rotary movement is made on the axis marked by the line that joins the middle fingers. With one of the hands, the movement is in the direction of movement clockwise, and with the other hand, simultaneously, in the opposite direction. By obtaining a symmetry in the movement in opposite directions, the movement is made in the same direction with both hands, first forwards and then backwards. Note how the ring fingers rotate first backwards and then upwards. Symmetry in movements should also be sought.
| Study group | Role | What they receive |
|---|---|---|
| Specific joint mobilization post muscle inhibition on C1 and C2 | Experimental | Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. There will be 4 treatment sessions distributed over 2 weeks. Receives: Procedure: Specific joint mobilization post muscle inhibition on C1; Procedure: Specific joint mobilization post muscle inhibition on C2 |
| Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions | Experimental | Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. Myofascial inductions will also be applied to the cranial and cervical fascia, as well as to the suboccipital, pectoral, angular scapula, sternocleidomastoid, trapezius, internal and external pterygoid, masseter and temporal muscles. There will be 4 treatment sessions distributed over 2 weeks. Receives: Procedure: Specific joint mobilization post muscle inhibition on C1; Procedure: Specific joint mobilization post muscle inhibition on C2; Procedure: Myofascial inductions; Suboccipital induction; Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 1; Procedure: Myofascial inductions; Horizontal induction of the TMJ.; Procedure: Myofascial inductions; Posterior elongation of the cervical fascia in the supine position; Procedure: Myofascial induction; Angle of the scapula; Procedure: Myofascial induction sternocleidomastoid muscles; Procedure: Myofascial induction of pectoralis major and minor; Procedure: Myofascial induction; upper trapezius; Procedure: Myofascial induction, of the fascia of the subscapularis muscle; Procedure: Intraoral myofascial induction of the masseter; Procedure: Deep myofascial induction of the external pterygoid; Procedure: Intraoral mifascial induction of the internal pterygoid; Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 2 |
| Maitland C2 + SNAG C1 | Active comparator | The Maitland technique will be applied, central postero-anterior passive joint mobilization in the C2 vertebra. As well as the sustained apophyseal slip technique (SNAG) in rotation on C1. The dosage is from 1 to 5 mobilizations per technique. There will be 4 treatment sessions distributed over 2 weeks. Receives: Procedure: Maitland C2; Procedure: SNAG C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of movement
The cervical flexion-rotation test (CFRT) will be measured in degrees of motion. CFRT is effective in evaluating the presence/absence of upper cervical spine dysfunction. If there are symptoms and the range is decreased by more than 10º (normal is 44º on each side), the test is considered positive and, therefore, there is a limitation in the C1-C2 level. The instrument that will be used to measure the rotation of the upper cervical spine in degrees will be the Compass mobile application that has been validated to measure cervical ROM. The goal is to measure the change in range of motion before and after treatment.
Measured: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Secondary outcomes (1)
Neck Disability Index
It is a 10-item questionnaire that measures disability related to a patient's neck pain. Each question is measured on a scale of 0 (no disability) to 5, and an overall score of 100 is calculated by adding the score for each item and multiplying it by two. A higher NDI score means greater patient perceived disability due to neck pain. The "minimum clinically important change" by patients has been found to be 5-10%. The objective is to measure the change in the disability index before and after treatment.
Measured: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start30 Aug 2021
- Primary completionAug 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The sample will be divided into three intervention groups. Two experimental groups and a control group. Experimental group A: Will receive as treatment the specific joint mobilization technique post muscle inhibition (MAEPI). Experimental group B: Will receive the MAEPI technique as treatment and myofascial induction techniques will be added. The control group: will receive two techniques whose effectiveness is scientifically proven. Which are: Maitland central posterior-anterior passive joint mobilization in C2 + Sustained natural apophyseal sliding (SNAG) in rotation on C1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Catelotti, Universidad Nacional de Córdoba
- Investigators
- Franco Catelotti, Principal investigator, Universidad Nacional de Córdoba; Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447338
- Sponsor's protocol ID
- 4241
- Status last verified
- Jan 2025
- First submitted
- 25 May 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall TM, Briffa K, Hopper D, Robinson K. Comparative analysis and diagnostic accuracy of the cervical flexion-rotation test. J Headache Pain. 2010 Oct;11(5):391-7. doi: 10.1007/s10194-010-0222-3. Epub 2010 May 28.
PubMed 20508964
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Post Muscle Inhibition Specific Joint Mobilization on Range of Motion and Pain in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05447338
- Acronym / sponsor ID
- 4241
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Rehabilitation, Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. An important finding is that approximately 60% of total cervical rotation takes place at C1-C2, regardless of age. The test used to diagnose dysfunction of the upper cervical spine is the Cervical Rotation Flexion Test (CRFT) and is measured in degrees through various instruments, the most current validated by scientific literature are mobile applications (Clinometer and Compass ). Having in clear the importance of the location (C1-C2) of the origin of many of the symptoms and signs that cervicalgia generates and mainly the restriction of the range of movement that they produce in the cervical spine. It is that the manual therapy technique: Joint mobilization post muscular inhibition (MAEPI) that is included in this study for its analysis, is directed to this segment of the cervical spine. This differs from other similar techniques, in terms of location and movement of the joint surfaces, which have been previously studied and have shown their effectiveness (techniques that will be used in the control group), in that the micro movements of the joint surfaces ( joint arthrokinematics) based on the principles of Kaltenborn-Evjenth will be combined with the principles of the hold relax technique belonging to the Proprioceptive Neuromuscular Facilitation method. The main therapeutic objective of the MAEPI technique is to improve mobility and reduce pain in the cervical spine.
Hypothesis: The MAEPI technique will improve mobility and reduce neck pain as well as other symptoms associated with neck pain, such as headache, dizziness and nausea, and will be more effective than those of the control group (Maitland central posterior-anterior passive joint mobilization in C2 and natural apophyseal slippage sustained (SNAG) in rotation about Mulligan's C1). The MAEPI technique will be more effective when applied later to myofascial induction techniques.
Detailed description
Main goal
-Determine the effectiveness of the MAEPI applied on C1-C2 on the improvement of the range of motion and pain in patients with mechanical neck pain. As well as its effectiveness after performing myofascial induction techniques.
Specific objectives
- Identify the disability index, the intensity of the pain and the degree of mobility of the patients before and after the application of the proposed treatment protocols.
- Identify other symptoms associated with neck pain, such as dizziness, headache and nausea before and after the application of treatment protocols.
- Establish whether there are significant differences in terms of ROM between the proposed protocols, taking into account age, sex, work activity of individuals with neck pain in relation to evolution.
Sample size: The sample size estimate was based on data from previous studies. The standard deviation of 11.1º of the range of motion of the average of the CRFT measurements in patients with upper cervical dysfunction was used. The calculation was performed using the GRANMO sample size calculator (version 7). For an analysis of variance, accepting an alpha risk of 0.05 and a beta risk of less than 0.2 in a unilateral contrast, 38 subjects are needed in each group to detect a minimum difference of 8º between two groups, assuming that there are 3 groups and a deviation 11.1º standard. A rate of loss to follow-up of 10% has been estimated. In the case of repeated paired means by group (experimental group A, MAEPI), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 16 subjects are required to detect a difference equal to or greater than 8 degrees. A standard deviation of 11.1 is assumed. A rate of loss to follow-up of 0% has been estimated.
Data analysis: The InfoStat program will be used. The data will be analyzed according to the nature of each variable in the ANAVA study, non-linear regression, categorical, correlational data and multiple comparisons test (Fisher's test), establishing significant differences when p<0.05 for all cases. The variables dizziness, headache and nausea: they will be evaluated using a qualitative table and later they will be compared using the Chi square test. In the experimental group A: MAEPI, the t test will be performed for paired data (before and after, for the intervention group of the technique alone).
Expected results
Regarding therapeutic effects, it is expected that:
- Experimental Group A is superior to the Control Group.
- Experimental Group B is superior to Experimental Group A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The sample will be divided into three intervention groups. Two experimental groups and a control group. Experimental group A: Will receive as treatment the specific joint mobilization technique post muscle inhibition (MAEPI). Experimental group B: Will receive the MAEPI technique as treatment and myofascial induction techniques will be added. The control group: will receive two techniques whose effectiveness is scientifically proven. Which are: Maitland central posterior-anterior passive joint mobilization in C2 + Sustained natural apophyseal sliding (SNAG) in rotation on C1.
| Arm | Type | Receives |
|---|---|---|
| Specific joint mobilization post muscle inhibition on C1 and C2 | Experimental | Procedure: Specific joint mobilization post muscle inhibition on C1, Procedure: Specific joint mobilization post muscle inhibition on C2Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. There will be 4 treatment sessions distributed over 2 weeks. |
| Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions | Experimental | Procedure: Specific joint mobilization post muscle inhibition on C1, Procedure: Specific joint mobilization post muscle inhibition on C2, Procedure: Myofascial inductions; Suboccipital induction, Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 1, Procedure: Myofascial inductions; Horizontal induction of the TMJ., Procedure: Myofascial inductions; Posterior elongation of the cervical fascia in the supine position, Procedure: Myofascial induction; Angle of the scapula, Procedure: Myofascial induction sternocleidomastoid muscles, Procedure: Myofascial induction of pectoralis major and minor, Procedure: Myofascial induction; upper trapezius, Procedure: Myofascial induction, of the fascia of the subscapularis muscle, Procedure: Intraoral myofascial induction of the masseter, Procedure: Deep myofascial induction of the external pterygoid, Procedure: Intraoral mifascial induction of the internal pterygoid, Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 2Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. Myofascial inductions will also be applied to the cranial and cervical fascia, as well as to the suboccipital, pectoral, angular scapula, sternocleidomastoid, trapezius, internal and external pterygoid, masseter and temporal muscles. There will be 4 treatment sessions distributed over 2 weeks. |
| Maitland C2 + SNAG C1 | Active comparator | Procedure: Maitland C2, Procedure: SNAG C1The Maitland technique will be applied, central postero-anterior passive joint mobilization in the C2 vertebra. As well as the sustained apophyseal slip technique (SNAG) in rotation on C1. The dosage is from 1 to 5 mobilizations per technique. There will be 4 treatment sessions distributed over 2 weeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- You must have a medical indication for cervical physiotherapy.
- Must present decreased ROM of the upper cervical spine assessed with CRFT, either acute or subacute and of a mechanical type or PN and grade I and II of severity according to The Neck Pain Task Force.
Key exclusion criteria (4 listed)
- Joint instability, dislocations, fractures or stenosis of the cervical spinal canal.
- Malformations and/or bony alterations of the cervical spine or the brain.
- Head injury or whiplash in the last 10 years. Infections, unhealed wounds, tumors, vascular pathology or cancer that compromises the cervical spine and/or the brain.
- Being under treatment with anti-inflammatories, muscle relaxants or some type of pain reliever.
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 |
|---|---|---|
| Specific joint mobilization post muscle inhibition on C1Grasp the hand with the thumb or forefinger at the spinous process of C1. The contratoma hand is placed in forceps with the thumb and forefinger on the patient's temple, one on each side. Resisting with the hand on the temple, the therapist asks the patient to perform a 6-second isometric contraction of the cervical spine flexor muscles. The therapist then instructs the patient to relax the musculature and simultaneously performs posteroanterior pressure on the spinous process of C2 and passive extension of the head (with the hand on the temple). The maneuver is repeated until the therapist notices the release in the flexion-extension movement of the head. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2, Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Maitland C2Maitland central posterior-anterior passive joint mobilization at C2: The patient will lie prone, the therapist behind the patient's head, with both thumbs will apply a central force on the spinous process of C2. The duration of the application will be up to five applications of 10 to 30 seconds in duration, depending on clinical judgment. | Procedure or surgery | Maitland C2 + SNAG C1 |
| SNAG C1Sustained natural apophyseal slippage (SNAG) will be applied e.g. in the case of wanting to improve the left rotation. The therapist performs a sustained anterior glide to the C1 transverse process on the left. The participant will be seated, simultaneously rotating their head to the left while holding the SNAG. The glide of C1 will be maintained by the therapist until the participant's head returns to the neutral starting position. The same will be done, but in the opposite direction to improve the right rotation. | Procedure or surgery | Maitland C2 + SNAG C1 |
| Specific joint mobilization post muscle inhibition on C2The therapist rotates the head to the right side until the final sensation of the movement is noted, either due to pain or muscular tension. From this position, the therapist asks the patient to rotate the head to the left side while offering resistance with both hands in the opposite direction, in such a way as to generate an isometric contraction of the rotator muscles of the head to the left. The therapist then asks the patient to hold the position for 6 seconds. Subsequently, the therapist with the finger in the transverse process of C1, pushes it in the postero-anterior direction and simultaneously (with the contratome hand) rotates the patient's head to the right. The technique is repeated until the ROM improves, always taking into account the patient's tolerance. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2, Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial inductions; Suboccipital inductionThe therapist places his hands under the patient's head in such a way that he can palpate the spinous processes of the cervical vertebrae with his fingers. Next, slowly bring your fingers up until they contact the occipital condyles. At this time he should gently move his fingers downward, thus finding the space between the condyles and the spinous process of the axis. Next, flexing the metacarpophalangeal joints to 90°, slowly elevate the skull. The therapist's hands should remain together and the base of the skull should rest on their palms. The therapist should apply pressure with the index, middle and ring fingers of each hand. This pressure should be maintained for a few minutes until a release of the fascia is noted. In the last phase of the technique, the therapist, without releasing the pressure, opens his hands and slowly brings his head back. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial inductions; Synchronization of the temporal bones PHASE 1The therapist rests his two forearms on the table, in such a way that he can contact the external auditory canal with his middle fingers. Place the ring fingers on the mastoid processes and the index fingers on the zygomatic arches. Subsequently, a rotary movement is made on the axis marked by the line that joins the middle fingers. With one of the hands, the movement is in the direction of movement clockwise, and with the other hand, simultaneously, in the opposite direction. By obtaining a symmetry in the movement in opposite directions, the movement is made in the same direction with both hands, first forwards and then backwards. Note how the ring fingers rotate first backwards and then upwards. Symmetry in movements should also be sought | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial inductions; Horizontal induction of the TMJ.The therapist places the middle fingers of both hands on the lingual aspect of the lower molar teeth and then gently presses towards the table. This pressure must be maintained for a minimum of 90 to 120 seconds. Afterwards, the therapist, very attentive to the changes in the direction of the fascial restriction, follows the release movement. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial inductions; Posterior elongation of the cervical fascia in the supine positionPosition of the patient, lying on the stretcher in the supine position. Therapist position: Sitting at the head of the table. Technique: With one of his hands, the therapist supports the patient's head on the occipital area and slowly brings it to flexo-elevation. With the other hand, he contacts the mass of the paravertebral muscles, placing the thumb on one side of the spine and the proximal interphalangeal joint of the index finger in flexion on the other. While one hand holds the head position, the other performs a downward vertical slide. The maneuver is repeated between 3 and 7 times in a slow and progressive manner. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial induction; Angle of the scapulaPosition of the patient, supine position, with the arm resting along the trunk. Position of the therapist, standing or sitting at the head of the table. The therapist places one of his hands under the shoulder blade, embracing the lower angle with the fingertips and bringing it slightly cranially. This maneuver frees access to the superior angle of the scapula, which makes it easier for the index and middle fingers of the other hand to contact the insertion of the angle. More sustained pressure is applied to this point, while the hand placed on the scapula moves in the direction of release. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial induction sternocleidomastoid musclesObjective, release the myofascial restrictions of the fascia of the SCM muscle. Position of the patient, supine position with the head near the upper edge of the stretcher. Therapist position. sitting at the head of the stretcher. Technique: The therapist, with one hand placed on the occipital region, gently rotates the patient's head. The other hand places it on the mass of the SCM muscle with the thumb at the point of insertion on the mastoid process. While one hand applies the rotational movement and a slight extension of the head, the other performs a transverse slide over the zone of restriction in the SCM muscle. A longitudinal sliding movement of the SCM muscle can be made between the thumb and forefinger of the executing hand. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial induction of pectoralis major and minorObjective, release the fascia of the pectoralis major and minor muscle. Position of the patient, supine position, with the arm abducted to about 120 degrees. Position of the therapist, standing next to the patient, at head height. Technique: with his cranial hand, the therapist holds the patient's arm, and with the caudal hand, placed in a prone position, contacts the space between pectoralis major and ribs. This contact is made with the fingertips. The pressure should be maintained for about 5 minutes. As the release occurs, both of the therapist's hands must adjust to the direction of the changes. When detecting the restriction in the pectoralis minor, the penetration should be deepened with the hand, sliding it over the ribs. Contact and restraints with the pectoralis minor and major are often particularly painful, forcing the therapist to apply controlled force. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial induction; upper trapeziusObjective, release the myofascial restrictions of the upper trapezius. Position of the patient, supine, with the elbow flexed and the hand resting on the abdomen, and the arm in a slight abduction. Therapist position, sitting at the head of the table. Technique: The therapist places his hand on the patient's shoulder so that he can grasp the fibers of the upper trapezius between the index, middle, and ring fingers above and the thumb below. Subsequently, he exerts gentle and sustained pressure overcoming three restraining barriers. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial induction, of the fascia of the subscapularis musclePosition of the patient, supine, with the arm raised about 90-160 degrees, depending on the degree of movement restriction. Therapist position, standing at the head of the table. Phase A With his cranial hand, the therapist holds the patient's arm and performs very gentle traction. The palm of the caudal hand, thumb up, is placed on the outer edge of the scapula, as close as possible to the glenohumeral joint. A slight traction is performed with both hands in opposite directions, subsequently following the direction of release. Phase B, The thumb of the caudal hand slightly invades the space between the inner aspect of the scapula and the thorax. The rest of the application is performed as in phase A. Phase C, the therapist places his caudal hand in a prone position and slowly penetrates the aforementioned space with the tips of the fingers. sustained for a time ranging between 90 seconds and 5 minutes, following the release stages. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Intraoral myofascial induction of the masseterPosition of the patient, supine position, on the stretcher without the pillow. Position of the therapist, sitting at the head of the table. Technique: The therapist, with the index of his hand, contacts the masseter just below the zygomatic arch and inside the mouth. To ensure proper contact on the masseter, the patient is asked to attempt to close the mouth. Once the muscle is correctly located, the patient should immediately relax the masseter. Next, the therapist compresses the masseter between his index finger and thumb. You have to wait long enough for the release to occur. Sometimes both hands are used by placing the forefinger of the other hand on the outer surface. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Deep myofascial induction of the external pterygoidObjective, release the myofascial restrictions and recover the functional coordination of the external pterygoid muscles. Position of the patient, supine position, on the stretcher without the pillow. Therapist position, sitting at the head of the table. Technique: The therapist palpates the temporomandibular joint with the index or middle finger of one hand. With the index finger of the other hand, he contacts the pterygoid inside the mouth and maintains pressure until release occurs. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Intraoral mifascial induction of the internal pterygoidObjective, release the restrictions of the internal pterygoid fascia. Position of the patient, supine position on the stretcher. Therapist position, sitting laterally at the head of the stretcher and looking at the patient. Technique: Therapist palpates the TMJ with the index or middle finger of one hand. With the index of the other hand, he contacts the pterygoid inside the mouth and maintains pressure until release occurs. You have to wait three consecutive releases. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
| Myofascial inductions; Synchronization of the temporal bones PHASE 2The therapist rests his two forearms on the table, in such a way that he can contact the external auditory canal with his middle fingers. Place the ring fingers on the mastoid processes and the index fingers on the zygomatic arches. Subsequently, a rotary movement is made on the axis marked by the line that joins the middle fingers. With one of the hands, the movement is in the direction of movement clockwise, and with the other hand, simultaneously, in the opposite direction. By obtaining a symmetry in the movement in opposite directions, the movement is made in the same direction with both hands, first forwards and then backwards. Note how the ring fingers rotate first backwards and then upwards. Symmetry in movements should also be sought. | Procedure or surgery | Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions |
Primary outcome
Degrees of movement
Time frame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
The cervical flexion-rotation test (CFRT) will be measured in degrees of motion. CFRT is effective in evaluating the presence/absence of upper cervical spine dysfunction. If there are symptoms and the range is decreased by more than 10º (normal is 44º on each side), the test is considered positive and, therefore, there is a limitation in the C1-C2 level. The instrument that will be used to measure the rotation of the upper cervical spine in degrees will be the Compass mobile application that has been validated to measure cervical ROM. The goal is to measure the change in range of motion before and after treatment.
1 secondary outcome
Neck Disability Index
Time frame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 20508964Hall TM, Briffa K, Hopper D, Robinson K. Comparative analysis and diagnostic accuracy of the cervical flexion-rotation test. J Headache Pain. 2010 Oct;11(5):391-7. doi: 10.1007/s10194-010-0222-3. Epub 2010 May 28.
- 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.
Franco Catelotti principal investigator
Universidad Nacional de Córdoba; Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific joint mobilization post muscle inhibition on C1, Maitland C2 and SNAG C1 in people with Neck Pain, run by Universidad Nacional de Córdoba at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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 Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franco Catelotti (3516640194, franco.catelotti@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degrees of movement (time frame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.