Neck PainNCT03670719
Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction
A study testing Manual Therapy and Exercise and Exercise in people with Neck Pain and Cervical Pain, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
There is a lot of scientific evidence about the effectiveness of manual therapy and exercise / training in subjects with cervical pain. Most of the high quality systematic reviews agree on the need to combine manual therapy and exercise for the treatment of chronic cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neck Pain, Cervical Pain
- What is being tested?
- Manual Therapy and Exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2018to 1 Jan 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Medical diagnosis of chronic cervical pain (more than 3 months of cervical pain evolution)
- Positive flexion rotation test
Who cannot join
- Recent spine, head or mouth surgery.
- Diabetes mellitus
- Recent infection and/or inflammatory arthritis, and cervical and/or brain traumatism records.
- Contraindication for manual therapy or cervical training
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences of University of Zaragoza
Zaragoza, 50009
About this study
Official title: Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction: A Randomized Controlled Trial
There is a lot of scientific evidence about the effectiveness of manual therapy and exercise / training in subjects with cervical pain. Most of the high quality systematic reviews agree on the need to combine manual therapy and exercise for the treatment of chronic cervical pain. However, articles that focus on manual therapy in the treatment of the upper cervical spine are not as common, being that the most commonly prescribed exercises are those of craniocervical flexion, (flexion of the upper cervical spine).
The investigators believe that participants who are going to benefit more from the integration of manual therapy and exercise will be those who have a real restriction of the upper cervical spine, and for these, is indispensable, the application of manual therapy techniques before the integration of the active exercise to obtain optimal results.
Read more
This project is going to try to define participants with chronic cervical pain and upper cervical spine restriction that may benefit more from the combination of manual therapy and exercise than the rest. The investigators are going to study changes in different variables about function, pain, ultrasound, muscle tone, joints... Strengthen the importance of specificity in physiotherapy interventions and increase the evidence on the importance of manual therapy in a subgroup of participants with chronic cervical pain, improve knowledge about the involvement of the upper cervical spine in cervical pathology and check the effectiveness of a self-treatment program for participants with chronic cervical pain.
The objective of this trial is to compare the effectiveness of an integrative approach of manual therapy associated with exercise versus exercise in participants with chronic cervical pain and upper cervical spine dysfunction.
For this purpose, the investigators conduct a randomized controlled trial, simple-blind (Only is possible to blind the evaluator).
The Sample size is 52 participants (2 groups of 26 participants). One of the groups will receive 4 training sessions with exercises for the cervical spine between 30 and 45 minutes duration per session and the other group will receive 4 sessions of a combination of manual therapy and training exercises also between 30 and 45 minutes each session. In addition, all participants will receive self-treatment techniques for self-management of their dysfunction.
Cervical exercises will consist of a set of training techniques to improve the function and symptomatology that the participant has. These exercises have been widely evidenced and do not suppose any health risk.
The techniques of manual therapy can be the manipulation technique in resting position, vertebral mobilization and / or musculature (massage and / or stretching). All the treatments applied follow the safety recommendations of the International Federation of Orthopedic Manual Therapists (IFOMPT). If participants need clarification, they can talk to the principal investigator (Jacobo Rodríguez Sanz) at any time.
One physiotherapist will perform the physical examination, and a different one will apply the treatment. Physical therapists doing the screening will not know which group has been assigned to them, so the participant will be asked not to provide the evaluators any information about the assignment of his group to improve the quality of the study.
The examination will consist of tests to assess whether the participant is a candidate to participate in the study, the measurement of pain, the exhaustive assessment of all cervical musculature with different measuring instruments and the measurement of joint mobility.
The first day theparticipant be given information about his pain, his daily habits and activities that he usually does.
The assessment of his problem will consist in the measurement of the amount of movement he can makes in the cervical area without pain, the ability to orient himself in certain movements with his eyes closed, the intensity of his pain, the evaluation of the state of his muscles. stabilizing as a mobilizer through ultrasound, muscle test and palpation. The functionality of his cervical vertebrae will also be evaluated and he will be asked different questionnaires about the functionality, pain and condition of his cervical pain, headache (in case of suffering) and kinesiophobia.
Both the evaluation and the treatment will be without pain. In addition, he will be given a series of personalized exercises to improve his problem, which must be done every day during the study.
- Conditions
- Neck Pain, Cervical Pain
- Being tested
- Manual Therapy and Exercise, Exercise
- Keywords
- manual therapy, exercise, physiotherapy, chronic cervical pain, upper cervical spain
- 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.
Manual Therapy and ExerciseOther
Combination of physiotherapy (manual therapy) techniques and exercises for the cervical spine
ExerciseOther
Exercises for the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy and Exercise Group | Experimental | Combination of manual therapy and exercises for chronic cervical pain Receives: Other: Manual Therapy and Exercise |
| Exercise Group | Active comparator | Only exercises for chronic cervical pain Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index (NDI) Questionnaire
The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Measured: Change between baseline (immediately before intervention) and post intervention (1 month), after 3 months
Change in Flexion Rotation Test (FRT)
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
Secondary outcomes (4)
Change in Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. This force is applied by a portable and digital machine. This machine has a push button so the patient can press at the moment in which the applied force begins to be slightly painful. When the patient presses the button, the evaluator registers the number that appears on the screen.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
Change in Cervical Range of Movement
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Change in Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Change in Ultrasound
To measure the thickness of the longus colli muscle
Measured: Change between baseline(immediately before intervention) and post intervention (1 month), after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Oct 2018
- Primary completion1 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez-Sanz, Universidad de Zaragoza
- Investigators
- Jacobo Rodríguez-Sanz, Pt, Principal investigator, Physiotherapy Research Unit, University of Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670719
- Sponsor's protocol ID
- N13/2018
- Status last verified
- Feb 2020
- First submitted
- 6 Sep 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03670719
- Acronym / sponsor ID
- N13/2018
- Conditions
- Neck Pain, Cervical Pain
- Keywords
- manual therapy, exercise, physiotherapy, chronic cervical pain, upper cervical spain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Sep 2018 (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.
There is a lot of scientific evidence about the effectiveness of manual therapy and exercise / training in subjects with cervical pain. Most of the high quality systematic reviews agree on the need to combine manual therapy and exercise for the treatment of chronic cervical pain. However, articles that focus on manual therapy in the treatment of the upper cervical spine are not as common, being that the most commonly prescribed exercises are those of craniocervical flexion, (flexion of the upper cervical spine).
The investigators believe that participants who are going to benefit more from the integration of manual therapy and exercise will be those who have a real restriction of the upper cervical spine, and for these, is indispensable, the application of manual therapy techniques before the integration of the active exercise to obtain optimal results.
This project is going to try to define participants with chronic cervical pain and upper cervical spine restriction that may benefit more from the combination of manual therapy and exercise than the rest. The investigators are going to study changes in different variables about function, pain, ultrasound, muscle tone, joints... Strengthen the importance of specificity in physiotherapy interventions and increase the evidence on the importance of manual therapy in a subgroup of participants with chronic cervical pain, improve knowledge about the involvement of the upper cervical spine in cervical pathology and check the effectiveness of a self-treatment program for participants with chronic cervical pain.
The objective of this trial is to compare the effectiveness of an integrative approach of manual therapy associated with exercise versus exercise in participants with chronic cervical pain and upper cervical spine dysfunction.
For this purpose, the investigators conduct a randomized controlled trial, simple-blind (Only is possible to blind the evaluator).
The Sample size is 52 participants (2 groups of 26 participants). One of the groups will receive 4 training sessions with exercises for the cervical spine between 30 and 45 minutes duration per session and the other group will receive 4 sessions of a combination of manual therapy and training exercises also between 30 and 45 minutes each session. In addition, all participants will receive self-treatment techniques for self-management of their dysfunction.
Cervical exercises will consist of a set of training techniques to improve the function and symptomatology that the participant has. These exercises have been widely evidenced and do not suppose any health risk.
The techniques of manual therapy can be the manipulation technique in resting position, vertebral mobilization and / or musculature (massage and / or stretching). All the treatments applied follow the safety recommendations of the International Federation of Orthopedic Manual Therapists (IFOMPT). If participants need clarification, they can talk to the principal investigator (Jacobo Rodríguez Sanz) at any time.
One physiotherapist will perform the physical examination, and a different one will apply the treatment. Physical therapists doing the screening will not know which group has been assigned to them, so the participant will be asked not to provide the evaluators any information about the assignment of his group to improve the quality of the study.
The examination will consist of tests to assess whether the participant is a candidate to participate in the study, the measurement of pain, the exhaustive assessment of all cervical musculature with different measuring instruments and the measurement of joint mobility.
The first day theparticipant be given information about his pain, his daily habits and activities that he usually does.
The assessment of his problem will consist in the measurement of the amount of movement he can makes in the cervical area without pain, the ability to orient himself in certain movements with his eyes closed, the intensity of his pain, the evaluation of the state of his muscles. stabilizing as a mobilizer through ultrasound, muscle test and palpation. The functionality of his cervical vertebrae will also be evaluated and he will be asked different questionnaires about the functionality, pain and condition of his cervical pain, headache (in case of suffering) and kinesiophobia.
Both the evaluation and the treatment will be without pain. In addition, he will be given a series of personalized exercises to improve his problem, which must be done every day during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy and Exercise Group | Experimental | Other: Manual Therapy and ExerciseCombination of manual therapy and exercises for chronic cervical pain |
| Exercise Group | Active comparator | Other: ExerciseOnly exercises for chronic cervical pain |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and over
- Medical diagnosis of chronic cervical pain (more than 3 months of cervical pain evolution)
- Positive flexion rotation test
Key exclusion criteria (4 listed)
- Recent spine, head or mouth surgery.
- Diabetes mellitus
- Recent infection and/or inflammatory arthritis, and cervical and/or brain traumatism records.
- Contraindication for manual therapy or cervical training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy and ExerciseCombination of physiotherapy (manual therapy) techniques and exercises for the cervical spine | Other | Manual Therapy and Exercise Group |
| ExerciseExercises for the cervical spine | Other | Exercise Group |
Primary outcome
Change in Neck Disability Index (NDI) Questionnaire
Time frame: Change between baseline (immediately before intervention) and post intervention (1 month), after 3 months
The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Change in Flexion Rotation Test (FRT)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
4 secondary outcomes
Change in Pressure Pain Threshold
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
Change in Cervical Range of Movement
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Change in Numeric Pain Rating Scale (NPRS)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Change in Ultrasound
Time frame: Change between baseline(immediately before intervention) and post intervention (1 month), after 3 months
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 17 Feb 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.
Jacobo Rodríguez-Sanz, Pt principal investigator
Physiotherapy Research Unit, University of Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise and Exercise in people with Neck Pain and Cervical Pain, run by Universidad de Zaragoza at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 17 Feb 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 Spain. 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?
Change in Neck Disability Index (NDI) Questionnaire (time frame: Change between baseline (immediately before intervention) and post intervention (1 month), after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.