Neck PainNECKprojectNCT00713843
Effectiveness of Manual Therapy in Patients With Neck Pain.
A study testing Manual Therapy Utrecht and Physical Therapy in people with Neck Pain, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual Therapy Utrecht and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Feb 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least two weeks of neck pain
- Last episode starts at a maximum of one year ago
- Age between 18 and 70 years
- Patient is willing to undergo the treatment
- Neck pain is mechanical and can be provocated by movements or postures of the neck
- Neck pain is the main problem to treat
- Neck pain may also give pain in the upper arm or cervicogenic headaches
Who cannot join
- Appearance of "red flags"
- Cervical surgery in the past
- Pregnancy
- Whiplash trauma
- Health conditions with may disturb the treatment or makes it impossible to undergo the treatment.
- Not enough understanding of the Dutch questionnaires
- Undergoing treatments like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture, other types of exercise therapy during the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.
Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables.
Read more
Study design: The study is a single blind randomized controlled trial.
Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks.
Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.
Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied.
Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.
Read the detailed description
Detailed information about Manual Therapy according to the Utrecht School Manual Therapy (MTU)
MTU is based on assessing the patient's individual preference of functioning by documenting and interpreting their natural asymmetry in anatomical form, posture and movements. The normal asymmetry and variability of human form and movement function have been specified. Asymmetrical forms can be related to the asymmetrical movement function.
In addition to the general diagnostics, MTU is characterized by specific diagnostics. By means of this specific manual-therapeutic analysis the individual preference of functioning model of the patient is drawn up through analysis and interpretation of the individual asymmetry in form, posture and movement. Some explanations of the measurements and movements are: (preferred) hand folding; (preferred) arm folding; which eye is master eye; leg use in (preferred) kicking of a ball. The purpose here is to describe the optimal direction and position of movement axes for all joints according to this model.
When composing this model, firstly the individual characteristics (a number of preferred movements, a number of asymmetrical aspects of posture and form) are assessed. Documentation, notation and interpretation of these characteristics take place according to a protocol.
The objective of MTU is to optimize the positioning of movement axes in the joints. To achieve this, three-dimensional movements in the joints are executed repeatedly. To purpose fully position the movement axes the therapist should (repeatedly) perform passive joint movements with low velocity and high accuracy. In addition to examining the individual preference of movement, exploratory examination is carried out to recognize possible red flags and to determine the treatment indication.
Treatment is based on preferred movements found in the patient and the interpretation according to the protocol of these movements and not on the complaint of the patient. It is executed by applying passive articular movements in the spinal joints and the joints of the extremities. During this process physiological joint limitations are carefully observed; traction or high-velocity movements will not be applied, as may be the case in other forms of manual therapy.
The diagnostic examination of other forms of manual therapy focuses on joint function, stability, movement patterns, range of movement, and the severity of disorders. To diagnose the patients complaints, palpation of passive accessory and passive intervertebral movements are used. The results yield information as to tenderness (pain), restricted intersegmental motion (stiffness), and spasm (muscle tension).
- Conditions
- Neck Pain
- Being tested
- Manual Therapy Utrecht, Physical Therapy
- Keywords
- Neck Pain, Manuel Therapy Utrecht, Physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy UtrechtOther
Also called joint mobilisation and manipulation, exercise therapy with instruction
Manual Therapy (6 weeks).
Physical TherapyOther
Also called exercise therapy with instruction, massagetherapy
Physical Therapy (six weeks).
| Study group | Role | What they receive |
|---|---|---|
| 1 Manual Therapy Utrecht | Experimental | Manual Therapy Utrecht (MTU) During the first consultation the manual therapist enquires about the complaints of the patient. The manual therapist conducts a number of measurements according to protocol. During treatment preferred movements are executed by the manual therapist in the patient's joints. The treatment techniques used by the manual therapist are very gentle mobilizations, without high velocity thrust techniques and are in general painless. In Manual Therapy Utrecht (MTU) it is common to give advices and recommend exercises.
A treatment session lasts between 30 and 60 minutes (repeated after one or two weeks). The maximum number of sessions is six.
The manual therapist has a minimum of five years of working experience. Receives: Other: Manual Therapy Utrecht |
| 2 Physical Therapy - Exercise Therapy | Active comparator | The physical therapist conducts a complaint related function examination. Treatment consist of active exercises, manual traction or stretching and massage. The aims of active exercises are improvement of strength, mobility and movement coordination. Specific mobilization techniques are not a part of physiotherapeutic treatment. Treatment sessions take place no more than twice a week with a maximum of nine sessions (approximately 30 minutes) with a minimum of twenty minutes on active exercise therapy combined with instruction.
To prevent overlap with MTU (experimental arm), physical therapists are selected who are not (also) trained as manual therapists or have started this education.
The physical therapist has at least five years of working experience. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Perceived Effect (GPE), Neck disability index (NDI-DV )
Measured: 0-3-7-13-26-52 weeks
Secondary outcomes (1)
Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS)for pain and SF36 (Quality of life). Multidimensional Health Locus of Control (MHLC), credibility/ expectancy, Fear Avoidance Beliefs Questionaire (FABQ-DLV)
Measured: 0-3-7-13-26-52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rob Oostendorp, Radboud University Medical Center
- Investigators
- Rob Oostendorp, Prof. dr., Study chair, UMC St Radboud, IQ healthcare, Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713843
- Sponsor's protocol ID
- NL21128.091
- Acronym
- NECKproject
- Status last verified
- Mar 2015
- First submitted
- 30 Jun 2008
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Groeneweg R, Haanstra T, Bolman CAW, Oostendorp RAB, van Tulder MW, Ostelo RWJG. Treatment success in neck pain: The added predictive value of psychosocial variables in addition to clinical variables. Scand J Pain. 2017 Jan;14:44-52. doi: 10.1016/j.sjpain.2016.10.003. Epub 2016 Nov 2.
PubMed 28850429Groeneweg R, van Assen L, Kropman H, Leopold H, Mulder J, Smits-Engelsman BCM, Ostelo RWJG, Oostendorp RAB, van Tulder MW. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial. Chiropr Man Therap. 2017 Apr 28;25:12. doi: 10.1186/s12998-017-0141-3. eCollection 2017.
PubMed 28465824van Dongen JM, Groeneweg R, Rubinstein SM, Bosmans JE, Oostendorp RA, Ostelo RW, van Tulder MW. Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial. Eur Spine J. 2016 Jul;25(7):2087-96. doi: 10.1007/s00586-016-4526-0. Epub 2016 Mar 21.
PubMed 27001136Groeneweg R, Kropman H, Leopold H, van Assen L, Mulder J, van Tulder MW, Oostendorp RA. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT). BMC Musculoskelet Disord. 2010 Jan 24;11:14. doi: 10.1186/1471-2474-11-14.
PubMed 20096136
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00713843
- Acronym / sponsor ID
- NECKproject / NL21128.091
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Manuel Therapy Utrecht, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Jul 2008 (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.
Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.
Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables.
Study design: The study is a single blind randomized controlled trial.
Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks.
Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.
Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied.
Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.
Detailed description
Detailed information about Manual Therapy according to the Utrecht School Manual Therapy (MTU)
MTU is based on assessing the patient's individual preference of functioning by documenting and interpreting their natural asymmetry in anatomical form, posture and movements. The normal asymmetry and variability of human form and movement function have been specified. Asymmetrical forms can be related to the asymmetrical movement function.
In addition to the general diagnostics, MTU is characterized by specific diagnostics. By means of this specific manual-therapeutic analysis the individual preference of functioning model of the patient is drawn up through analysis and interpretation of the individual asymmetry in form, posture and movement. Some explanations of the measurements and movements are: (preferred) hand folding; (preferred) arm folding; which eye is master eye; leg use in (preferred) kicking of a ball. The purpose here is to describe the optimal direction and position of movement axes for all joints according to this model.
When composing this model, firstly the individual characteristics (a number of preferred movements, a number of asymmetrical aspects of posture and form) are assessed. Documentation, notation and interpretation of these characteristics take place according to a protocol.
The objective of MTU is to optimize the positioning of movement axes in the joints. To achieve this, three-dimensional movements in the joints are executed repeatedly. To purpose fully position the movement axes the therapist should (repeatedly) perform passive joint movements with low velocity and high accuracy. In addition to examining the individual preference of movement, exploratory examination is carried out to recognize possible red flags and to determine the treatment indication.
Treatment is based on preferred movements found in the patient and the interpretation according to the protocol of these movements and not on the complaint of the patient. It is executed by applying passive articular movements in the spinal joints and the joints of the extremities. During this process physiological joint limitations are carefully observed; traction or high-velocity movements will not be applied, as may be the case in other forms of manual therapy.
The diagnostic examination of other forms of manual therapy focuses on joint function, stability, movement patterns, range of movement, and the severity of disorders. To diagnose the patients complaints, palpation of passive accessory and passive intervertebral movements are used. The results yield information as to tenderness (pain), restricted intersegmental motion (stiffness), and spasm (muscle tension).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Manual Therapy Utrecht | Experimental | Other: Manual Therapy UtrechtManual Therapy Utrecht (MTU) During the first consultation the manual therapist enquires about the complaints of the patient. The manual therapist conducts a number of measurements according to protocol. During treatment preferred movements are executed by the manual therapist in the patient's joints. The treatment techniques used by the manual therapist are very gentle mobilizations, without high velocity thrust techniques and are in general painless. In Manual Therapy Utrecht (MTU) it is common to give advices and recommend exercises. A treatment session lasts between 30 and 60 minutes (repeated after one or two weeks). The maximum number of sessions is six. The manual therapist has a minimum of five years of working experience. |
| 2 Physical Therapy - Exercise Therapy | Active comparator | Other: Physical TherapyThe physical therapist conducts a complaint related function examination. Treatment consist of active exercises, manual traction or stretching and massage. The aims of active exercises are improvement of strength, mobility and movement coordination. Specific mobilization techniques are not a part of physiotherapeutic treatment. Treatment sessions take place no more than twice a week with a maximum of nine sessions (approximately 30 minutes) with a minimum of twenty minutes on active exercise therapy combined with instruction. To prevent overlap with MTU (experimental arm), physical therapists are selected who are not (also) trained as manual therapists or have started this education. The physical therapist has at least five years of working experience. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with at least two weeks of neck pain
- Last episode starts at a maximum of one year ago
- Age between 18 and 70 years
- Patient is willing to undergo the treatment
- Neck pain is mechanical and can be provocated by movements or postures of the neck
Key exclusion criteria (7 listed)
- Appearance of "red flags"
- Cervical surgery in the past
- Pregnancy
- Whiplash trauma
- Health conditions with may disturb the treatment or makes it impossible to undergo the treatment.
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 UtrechtAlso: joint mobilisation and manipulation, exercise therapy with instructionManual Therapy (6 weeks). | Other | 1 Manual Therapy Utrecht |
| Physical TherapyAlso: exercise therapy with instruction, massagetherapyPhysical Therapy (six weeks). | Other | 2 Physical Therapy - Exercise Therapy |
Primary outcome
Global Perceived Effect (GPE), Neck disability index (NDI-DV )
Time frame: 0-3-7-13-26-52 weeks
1 secondary outcome
Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS)for pain and SF36 (Quality of life). Multidimensional Health Locus of Control (MHLC), credibility/ expectancy, Fear Avoidance Beliefs Questionaire (FABQ-DLV)
Time frame: 0-3-7-13-26-52 weeks
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 18 Mar 2015.
- Derived from this study: PubMed 28850429Groeneweg R, Haanstra T, Bolman CAW, Oostendorp RAB, van Tulder MW, Ostelo RWJG. Treatment success in neck pain: The added predictive value of psychosocial variables in addition to clinical variables. Scand J Pain. 2017 Jan;14:44-52. doi: 10.1016/j.sjpain.2016.10.003. Epub 2016 Nov 2.
- Derived from this study: PubMed 28465824Groeneweg R, van Assen L, Kropman H, Leopold H, Mulder J, Smits-Engelsman BCM, Ostelo RWJG, Oostendorp RAB, van Tulder MW. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial. Chiropr Man Therap. 2017 Apr 28;25:12. doi: 10.1186/s12998-017-0141-3. eCollection 2017.
- Derived from this study: PubMed 27001136van Dongen JM, Groeneweg R, Rubinstein SM, Bosmans JE, Oostendorp RA, Ostelo RW, van Tulder MW. Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial. Eur Spine J. 2016 Jul;25(7):2087-96. doi: 10.1007/s00586-016-4526-0. Epub 2016 Mar 21.
- Derived from this study: PubMed 20096136Groeneweg R, Kropman H, Leopold H, van Assen L, Mulder J, van Tulder MW, Oostendorp RA. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT). BMC Musculoskelet Disord. 2010 Jan 24;11:14. doi: 10.1186/1471-2474-11-14.
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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.
Rob Oostendorp, Prof. dr. study chair
UMC St Radboud, IQ healthcare, Nijmegen
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 Utrecht and Physical Therapy in people with Neck Pain, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 inclusion and 7 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 18 Mar 2015. 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 Netherlands. 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?
Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (time frame: 0-3-7-13-26-52 weeks). 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 NCT00713843, which also lists 4 linked publications.
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 18 Mar 2015.