Musculoskeletal ManipulationsNCT04351971
Immediate Effects of the C0-C1 Mobilization Technique in Patients With Chronic Neck Pain
A study testing Intervention Group in people with Musculoskeletal Manipulations and Cervical Pain, run by Universidad San Sebastián at 1 site in Chile.
Trial summary
Background: Skeletal muscle-type pain is one of the main reasons for consultations in health centers. In Chile, it is estimated that the prevalence reaches 33% in men and 50% in women, increasing considerably with age, with cervical pain being one of the main conditions, estimating that 80% of the population has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Manipulations, Cervical Pain
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 10 Apr 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Chronic cervical pain
- Sign the informed consent form
Who cannot join
- History of cervical trauma (Sprains, fracture and / or dislocation of cervical joints)
- Subjects with administration of pain relievers, opiates or muscle relaxants
- Inability to tolerate the supine position
- Subjects with vertiginous syndrome
- Subjects with cognitive impairment
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Universidad San Sebastián
Concepción, 4081322
GONZALO ARIAS, M.ed., 56977623954, gonzalo.arias@uss.cl
About this study
Official title: Immediate Effects of the C0-C1 Mobilization Technique on Upper Cervical Mobility and Pressure Threshold in Patients With Chronic Neck Pain
Background: Skeletal muscle-type pain is one of the main reasons for consultations in health centers. In Chile, it is estimated that the prevalence reaches 33% in men and 50% in women, increasing considerably with age, with cervical pain being one of the main conditions, estimating that 80% of the population has experienced cervicalgia at some time. lifetime. The main symptom is neck pain and restriction of movement, mainly affecting the mobility of the upper cervical region. Although there are studies evaluating the effectiveness of manual techniques, there are currently no studies evaluating the effects on cervical muscle activity and pressure threshold. Therefore, the objective of the present investigation is to evaluate the immediate effects of a manual therapy technique on the threshold pressure of muscular trigger points and on the muscular activity of the upper cervical region in patients with chronic pain and restriction of cervical mobility. higher.
Methods: Clinical trial, randomized, prospective, double-blind study (patient and evaluator). The participants (21 subjects) were divided into 2 groups. The control group will receive a C0-C0 placebo mobilization technique and the experimental group will receive the C0-C1 mobilization technique. In both groups the technique will be carried out by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 min. Pressure threshold, activation of the superficial deep musculature and articular range of the upper cervical region will be measured.
Read the detailed description
Most cases of pain in the neck region are of mechanical origin. In Spain, its annual prevalence has been estimated to range between 16.7% and 75.1% 2. In Chile, the prevalence is estimated to be 30% in Men and 50% in women, increasing as age increases. It is estimated that, of these cases, 44% have a duration of 6 months or more, giving rise to difficulties not only at work but also in daily life, at home, economically, even in emotional aspects.
The most common symptom is pain in the neck region, which may be associated with restricted movement, dizziness, and manifestations of stress. A large proportion of movement of the cervical spine takes place in the C1-C2 segment, where up to 50% of the total rotation of the cervical spine occurs. There are several techniques to restore cervical mobility, but few of them comply with the guidelines of the IFOMPT (International Federation of Manual Orthopedic Therapists) on the safety and efficacy in the treatment of hypomobility of the upper cervical spine, avoiding positions at the end of the cervical range of motion, especially rotation and extension, and there is also limited scientific evidence of its effectiveness.
The C0-C1 dorsal mobilization technique complies with these recommendations and have been used in previous studies, although there is no evidence of its effects on range of motion, activation of deep cervical musculature and pressure threshold in patients with chronic mechanical cervicalgia. Therefore, the objective of the present investigation is to determine the effects of the dorsal mobilization technique of the atlanto-occipital joint (C0-C1) as adjuvant treatments for Kinesitherapy in users with chronic cervical pain of mechanical origin and rotation deficit in the upper cervical spine.
- Conditions
- Musculoskeletal Manipulations, Cervical Pain
- Being tested
- Intervention Group, Placebo group
- Keywords
- manual therapies, Chronic Pain, Range of Motion
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.
Placebo groupOther
The technique consists of placing the patient in the supine position, one hand is located in the arches of the atlas, the other hand is located in the occipital. The therapist's shoulder is located in the anterior region. This position is maintained for 5 minutes without exerting pressure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The dorsal sliding technique C0-C1 will be applied to this group. Receives: Other: Intervention Group |
| Placebo group | Sham comparator | A placebo dorsal mobilization technique will be applied Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in grade of range of motion of the cervical spine in patients with chronic neck pain
The procedure consists of evaluating the cervical flexion, extension, inclination and rotation ranges. The final record will correspond to the average of two measurements on one side and on the contralateral side. The range of motion will be measured with a goniometer
Measured: pre-intervention/immediately after the intervention
Secondary outcomes (1)
Changes in muscle pressure threshold, measured in kilograms, in patients with chronic neck pain
Minimum subject pressure perceived as painful when applied gradually and increasing. This variable is evaluated using an algometer measured in kilograms of pressure.
Measured: pre-intervention/immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start10 Apr 2020
- Primary completion20 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ManipulationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gonzalo arias alvarez, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351971
- Sponsor's protocol ID
- 1909-91
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of the C0-C1 Mobilization Technique on Upper Cervical Mobility and Pressure Threshold in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04351971
- Acronym / sponsor ID
- 1909-91
- Conditions
- Musculoskeletal Manipulations, Cervical Pain
- Keywords
- manual therapies, Chronic Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 17 Apr 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.
Background: Skeletal muscle-type pain is one of the main reasons for consultations in health centers. In Chile, it is estimated that the prevalence reaches 33% in men and 50% in women, increasing considerably with age, with cervical pain being one of the main conditions, estimating that 80% of the population has experienced cervicalgia at some time. lifetime. The main symptom is neck pain and restriction of movement, mainly affecting the mobility of the upper cervical region. Although there are studies evaluating the effectiveness of manual techniques, there are currently no studies evaluating the effects on cervical muscle activity and pressure threshold. Therefore, the objective of the present investigation is to evaluate the immediate effects of a manual therapy technique on the threshold pressure of muscular trigger points and on the muscular activity of the upper cervical region in patients with chronic pain and restriction of cervical mobility. higher.
Methods: Clinical trial, randomized, prospective, double-blind study (patient and evaluator). The participants (21 subjects) were divided into 2 groups. The control group will receive a C0-C0 placebo mobilization technique and the experimental group will receive the C0-C1 mobilization technique. In both groups the technique will be carried out by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 min. Pressure threshold, activation of the superficial deep musculature and articular range of the upper cervical region will be measured.
Detailed description
Most cases of pain in the neck region are of mechanical origin. In Spain, its annual prevalence has been estimated to range between 16.7% and 75.1% 2. In Chile, the prevalence is estimated to be 30% in Men and 50% in women, increasing as age increases. It is estimated that, of these cases, 44% have a duration of 6 months or more, giving rise to difficulties not only at work but also in daily life, at home, economically, even in emotional aspects.
The most common symptom is pain in the neck region, which may be associated with restricted movement, dizziness, and manifestations of stress. A large proportion of movement of the cervical spine takes place in the C1-C2 segment, where up to 50% of the total rotation of the cervical spine occurs. There are several techniques to restore cervical mobility, but few of them comply with the guidelines of the IFOMPT (International Federation of Manual Orthopedic Therapists) on the safety and efficacy in the treatment of hypomobility of the upper cervical spine, avoiding positions at the end of the cervical range of motion, especially rotation and extension, and there is also limited scientific evidence of its effectiveness.
The C0-C1 dorsal mobilization technique complies with these recommendations and have been used in previous studies, although there is no evidence of its effects on range of motion, activation of deep cervical musculature and pressure threshold in patients with chronic mechanical cervicalgia. Therefore, the objective of the present investigation is to determine the effects of the dorsal mobilization technique of the atlanto-occipital joint (C0-C1) as adjuvant treatments for Kinesitherapy in users with chronic cervical pain of mechanical origin and rotation deficit in the upper cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupThe dorsal sliding technique C0-C1 will be applied to this group. |
| Placebo group | Sham comparator | Other: Placebo groupA placebo dorsal mobilization technique will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and over
- Chronic cervical pain
- Sign the informed consent form
Key exclusion criteria (5 listed)
- History of cervical trauma (Sprains, fracture and / or dislocation of cervical joints)
- Subjects with administration of pain relievers, opiates or muscle relaxants
- Inability to tolerate the supine position
- Subjects with vertiginous syndrome
- Subjects with cognitive impairment
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 GroupThe patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes. | Other | Intervention Group |
| Placebo groupThe technique consists of placing the patient in the supine position, one hand is located in the arches of the atlas, the other hand is located in the occipital. The therapist's shoulder is located in the anterior region. This position is maintained for 5 minutes without exerting pressure. | Other | Placebo group |
Primary outcome
Changes in grade of range of motion of the cervical spine in patients with chronic neck pain
Time frame: pre-intervention/immediately after the intervention
The procedure consists of evaluating the cervical flexion, extension, inclination and rotation ranges. The final record will correspond to the average of two measurements on one side and on the contralateral side. The range of motion will be measured with a goniometer
1 secondary outcome
Changes in muscle pressure threshold, measured in kilograms, in patients with chronic neck pain
Time frame: pre-intervention/immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Musculoskeletal Manipulations and Cervical Pain, run by Universidad San Sebastián at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GONZALO ARIAS, M.ed. (56977623954, gonzalo.arias@uss.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in grade of range of motion of the cervical spine in patients with chronic neck pain (time frame: pre-intervention/immediately after the intervention). 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 17 Apr 2020.