Neck PainCNPNCT01792895
Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain
A study testing Manipulation, Mobilization and Mobilization with movement in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manipulation, Mobilization and Mobilization with movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Dec 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Chronic neck pain
Who cannot join
- Neck pain is associated with whiplash injuries.
- Resting blood pressure greater than 140/90 mmHg.
- Cervical radiculopathy.
- Cervical disc herniation.
- Fibromyalgia syndrome.
- Previous neck surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Better the One Type of Manual Therapy Than Others for to Treat the Patients With Chronic Neck Pain? : A Randomized Clinical Trial
The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate effects in range of motion and pain thresholds, and the interaction between psychological factors and the outcomes of these three types of manual therapy.
The hypothesis is that all manual therapies techniques will produce similar effects.
Read the detailed description
The randomized controlled trial included patients with mechanically reproducible CNP, ≥ age 18-years who are randomized into three groups of treatment. The main outcome measures were the Visual Analogue scale (VAS), and, with secondary measures of Neck Disability Index (NDI), Global Rating Of Change (GROC), Cervical Range Of Motion (CROM), Pressure Pain Threshold (PPT), State Trait Anxiety Inventory (STAI-T), Beck depression Inventory (BDI-II), Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale (PCS).
- Conditions
- Neck Pain
- Being tested
- Manipulation, Mobilization, Mobilization with movement
- Keywords
- Posterior Neck Pain, Cervical spine pain, Manual 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.
ManipulationProcedure or surgery
The Cervical Spine Manipulation is a manual therapy technique directed at the hypomobile and painful vertebral level. The subject was supine with the cervical spine in a neutral position. The index finger of the therapist applies contact over the posterolateral aspect of the zygapophyseal joint of the hypomobile vertebra. The therapist performs the technique taking account the most limited movement; lateral or rotational. A maximum of 2 attempts will performed on each subject regardless audible cavitation.
MobilizationProcedure or surgery
The mobilization is a passive oscillatory technique, applied over cervical region in the hypomobile cervical level, the patient will be in prone and the therapist standing at the head of the patients with his thumbs in opposition placed at the level of the facet of the hypomobile cervical vertebra. A posteroanterior(PA) oscillatory pressure is applied, through the thumbs, over the process of the hypomobile vertebra. This oscillatory mobilization, is performed at a frequency of 2Hz (with metronome control/steps) for 2 minutes and repeated 3 times. The rest time between each mobilization was 1 minute.
Mobilization with movementProcedure or surgery
This is a manual therapy technique that consist of applied a sustain pressure over cervical hypomobile symptomatic level and request to patient a pain free movement.
For performs it, the therapist placed his thumbs on the articular process of that level. The patient sitting. Then, the subject had to perform actively the painful motion while the therapist guides the movement of that vertebra and resists it while returning to neutral. The strength applied was parallel to the plane of the joint, and the procedure was performed in 3 sets of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Manipulation group | Active comparator | This Technique will be applied over four sessions, during two weeks Receives: Procedure: Mobilization; Procedure: Mobilization with movement |
| Mobilisation | Active comparator | This treatment will be applied on cervical spine during four sessions, over two weeks Receives: Procedure: Manipulation; Procedure: Mobilization with movement |
| Mobilization with movement | Active comparator | This Technique will be applied over four sessions, during two weeks Receives: Procedure: Manipulation; Procedure: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
visual analogue scale (VAS). Despite being a subjective evaluation, it has been documented in previous studies its reliability and validity and its sensitivity to the clinical changes. For this reason, this scale has been used in numerous clinical trials on neck pains to evaluate the results. The patient places a vertical mark on a flat horizontal line of 10 cm. One extreme is 0 (no pain) and the other extreme is 10 (maximum pain) and it must be a difference of 2 points in the evaluation range to produce minimal improvement which is clinically significant.
Measured: The Patients will be followed for 12 weeks after treatment
Secondary outcomes (3)
Neck disability
The Neck Disability Index (NDI) is an assessment tool used to record the perceived disability in patients with neck pain .It was developed by Howard Vernon from the well-known and validated Oswestry scale for low back pain. The NDI is a self-administered questionnaire with 10 sections. 7 related to activities of daily living, 2 related to pain and 1 with concentration. Each of the sections is scored from 0 to 5, and the total score is expressed as a percentage relative to the maximum possible. The Spanish version was used in this study. This scale offer a high levels of validity and reliability (infraclass correlation coefficient, ICC: 0.88), is stable against different cultural levels and is consistent and reliable. The minimum detectable change is 5 points out of 50, while it is recommended t 7 points as the minimum difference clinically important.
Measured: The Patients will be followed for 12 weeks after treatment
Active Cervical Range of Motion
The ACROM is an instrument that assesses the active range of motion of the cervical segment and has been used in numerous studies to evaluate the results in manual therapy. Furthermore, it has proven to be a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. It consists of an inclinometers system. Gravitational inclinometers for flexion-extension and lateral flexion, and magnetic inclinometers for rotation. The patient, sitting in a chair with the goniometer placed over his head, is asked to perform analytical neck movements (flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation) to the point of beginning of pain symptoms or, otherwise, to the fullest extent of mobility. Each movement is recorded three times to take the average.
Measured: The Patients will be followed for 12 weeks after treatment
Pressure Pain thresholds (PPTs)
Pressure pain threshold (PPT) was used in this study for measure the mechanical hyperalgesia. A digital algometer (FDX 25, Wagner Instruments, Greenwich, CT, USA) comprised of a rubber head (1 cm2) attached to a pressure gauge, was used to measure PPTs. Force was measured in kilograms/f (kgf). The measures were taken 3 times at the cervical spine (C2 spinous process), with an interval of 30 seconds between each of the measurements. An average of the 3 measurements was calculated to obtain a single value for each of the measured points in each of the assessments. The assessor localized the spinous process of C2.
Measured: pre-treatment and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionDec 2012
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josue Fernandez-Carnero, PhD, Principal investigator, Universidad Europea de Madrid/Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792895
- Sponsor's protocol ID
- A04-12
- Acronym
- CNP
- Status last verified
- Oct 2013
- First submitted
- 12 Feb 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Better the One Type of Manual Therapy Than Others for to Treat the Patients With Chronic Neck Pain? : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01792895
- Acronym / sponsor ID
- CNP / A04-12
- Conditions
- Neck Pain
- Keywords
- Posterior Neck Pain, Cervical spine pain, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate effects in range of motion and pain thresholds, and the interaction between psychological factors and the outcomes of these three types of manual therapy.
The hypothesis is that all manual therapies techniques will produce similar effects.
Detailed description
The randomized controlled trial included patients with mechanically reproducible CNP, ≥ age 18-years who are randomized into three groups of treatment. The main outcome measures were the Visual Analogue scale (VAS), and, with secondary measures of Neck Disability Index (NDI), Global Rating Of Change (GROC), Cervical Range Of Motion (CROM), Pressure Pain Threshold (PPT), State Trait Anxiety Inventory (STAI-T), Beck depression Inventory (BDI-II), Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale (PCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manipulation group | Active comparator | Procedure: Mobilization, Procedure: Mobilization with movementThis Technique will be applied over four sessions, during two weeks |
| Mobilisation | Active comparator | Procedure: Manipulation, Procedure: Mobilization with movementThis treatment will be applied on cervical spine during four sessions, over two weeks |
| Mobilization with movement | Active comparator | Procedure: Manipulation, Procedure: MobilizationThis Technique will be applied over four sessions, during two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Chronic neck pain
Key exclusion criteria (6 listed)
- Neck pain is associated with whiplash injuries.
- Resting blood pressure greater than 140/90 mmHg.
- Cervical radiculopathy.
- Cervical disc herniation.
- Fibromyalgia syndrome.
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 |
|---|---|---|
| ManipulationThe Cervical Spine Manipulation is a manual therapy technique directed at the hypomobile and painful vertebral level. The subject was supine with the cervical spine in a neutral position. The index finger of the therapist applies contact over the posterolateral aspect of the zygapophyseal joint of the hypomobile vertebra. The therapist performs the technique taking account the most limited movement; lateral or rotational. A maximum of 2 attempts will performed on each subject regardless audible cavitation. | Procedure or surgery | Mobilisation, Mobilization with movement |
| MobilizationThe mobilization is a passive oscillatory technique, applied over cervical region in the hypomobile cervical level, the patient will be in prone and the therapist standing at the head of the patients with his thumbs in opposition placed at the level of the facet of the hypomobile cervical vertebra. A posteroanterior(PA) oscillatory pressure is applied, through the thumbs, over the process of the hypomobile vertebra. This oscillatory mobilization, is performed at a frequency of 2Hz (with metronome control/steps) for 2 minutes and repeated 3 times. The rest time between each mobilization was 1 minute. | Procedure or surgery | Manipulation group, Mobilization with movement |
| Mobilization with movementThis is a manual therapy technique that consist of applied a sustain pressure over cervical hypomobile symptomatic level and request to patient a pain free movement. For performs it, the therapist placed his thumbs on the articular process of that level. The patient sitting. Then, the subject had to perform actively the painful motion while the therapist guides the movement of that vertebra and resists it while returning to neutral. The strength applied was parallel to the plane of the joint, and the procedure was performed in 3 sets of 10 repetitions. | Procedure or surgery | Manipulation group, Mobilisation |
Primary outcome
Visual Analogue Scale
Time frame: The Patients will be followed for 12 weeks after treatment
visual analogue scale (VAS). Despite being a subjective evaluation, it has been documented in previous studies its reliability and validity and its sensitivity to the clinical changes. For this reason, this scale has been used in numerous clinical trials on neck pains to evaluate the results. The patient places a vertical mark on a flat horizontal line of 10 cm. One extreme is 0 (no pain) and the other extreme is 10 (maximum pain) and it must be a difference of 2 points in the evaluation range to produce minimal improvement which is clinically significant.
3 secondary outcomes
Neck disability
Time frame: The Patients will be followed for 12 weeks after treatment
Active Cervical Range of Motion
Time frame: The Patients will be followed for 12 weeks after treatment
Pressure Pain thresholds (PPTs)
Time frame: pre-treatment and post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- web site of the UniversityLink provided by the sponsor.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Josue Fernandez-Carnero, PhD principal investigator
Universidad Europea de Madrid/Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation, Mobilization and Mobilization with movement in people with Neck Pain, run by Universidad Rey Juan Carlos 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 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. 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?
Visual Analogue Scale (time frame: The Patients will be followed for 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.