search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The influence of musculoskeletal physiotherapy on the immune response in patients with neck pain.


- candidate number28450
- NTR NumberNTR6961
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2018
- Secondary IDsNL61404.029.18 
- Public TitleThe influence of musculoskeletal physiotherapy on the immune response in patients with neck pain.
- Scientific TitleThe influence of musculoskeletal physiotherapy on the immune response in patients with neck pain.
- ACRONYMproject MoTION
- hypothesisBackground of the study: Neck pain is a major public health problem alleged in its high prevalence, substantial impact on daily life and huge societal costs. Musculoskeletal Physiotherapy (MP) is an effective treatment for patients with persistent non-specific neck pain and cervical radiculopathy for reducing pain intensity. The effects of MP are often immediately noticeable after treatment. However, it is currently unknown which working mechanism might cause these effects. In persistent neck pain patients, the immune response - cytokines concentration - identified through whole blood lipopolysaccharide stimulation is elevated compared to healthy control. MP is able to attenuate the in vitro immune response in healthy volunteers. Thereby, a potential mechanism of MP might be attenuation of the immune response. In a subgroup of neck pain patients, namely patients with cervical radiculopathy, an additional and specific mechanism is expected. Increasing evidence indicates a significant role for neuroinflammation in the pathophysiology of nerve injury, especially for activation of resident macrophages of the central nervous system: the microglia. In animal models, MP seems to be able to attenuate glial cell activation. However, the role of glial cells in cervical radiculopathy patients and influence of MP on glial cells in vivo is unknown. Therefore, the overall aim of this study is to gain insight into the immune response in patients with neck pain and cervical radiculopathy, the influence of MP on this immune response and the role of neuroinflammation in patients with cervical radiculopathy
- Healt Condition(s) or Problem(s) studiedCervical radiculopathy, Non-specific neck pain, Physiotherapy, Chronic pain, Immune system
- Inclusion criteriaPersistent non-specific neck pain (research question (1)(2)(4)) Inclusion: • Age between 18-65 years. • Minimal score of 4 on the Numeric Pain Rating Scale. • Persistent pain is defined as pain complaints longer than 6 weeks. • Can be classified as grade 1 or 2 non-specific neck pain (1). • By physical examination a range of motion deficiency on the cervico-thoracic junction and a cervical segment. • Written informed consent of the subject.
Cervical radiculopathy (research question (1)(3)(4)) Inclusion • Age between 18-65 years. • Minimal score of 4 on the Numeric Pain Rating Scale. • Cervical radiculopathy based on the clinical diagnosis confirmed by the Magnetic Resonance Imaging (MRI through a medical specialist). The compression must be caused by a discus protrusion or herniation. • Written informed consent of the subject.
Healthy control group (research question (1)) Inclusion • Age between 18-65 years. • Asymptomatic for neck or shoulder pain and other musculoskeletal conditions in the past 3 months. • Written informed consent of the subject.
- Exclusion criteriaPersistent non-specific neck pain (research question (1)(2)(4))
A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy or postpartum for 9 months • Contra-indications for phlebotomy (e.g. phlebitis) • Underwent treatment for current complaints for the last 6 weeks (e.g. physiotherapy, manual therapy, GP etc.) • Having mental health disorders (> 74 points on the MHI-5) • Taken one of the following medication for the last 6 weeks: corticosteroids (e.g. prednisone), immunomodulatory medication (e.g. methotrexate, infliximab etc.) and the use of botox for the last 3 months. • Taken one of the following medication: NSAID’s (e.g. diclofenac, ibuprofen, naproxen etc.), Aspirin, Simvastatin (58) for the last two weeks. • Jet lag (within 7 days), ongoing shift work and hippocampal damage (59). • Having one of the following medical diseases o Neurological disorders (e.g. MS, myelopathie, cervical stenosis etc.) o Traumatic disorders (e.g. cervical fracture, surgery in the neck area etc.) o Having a history of malignity o Rheumatic or inflammatory disorders (e.g. Spondylitis Ankylpoetica, Crohn disease, sarcoidosis, colitis ulcerous, rheumatic arthritis, COPD, spastic colon, psoriasis etc.) o Cardiac diseases (e.g. history of myocardial infarction, abnormal heart rhythms) o Allergic reaction or auto immune diseases (e.g. type 1 diabetic, hay fever) o Metabolic disorders (e.g. type 2 diabetic) o Endocrinology disorders (e.g. Cushing Syndrome) o Haematological disorders (e.g. clothing problem) o Psychological/psychiatric disorders (e.g. depression, current high stress, , Alzheimer disease) o Physical trauma for the last six weeks o Having the flue
Cervical radiculopathy (research question (1)(4)) A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy or postpartum for 9 months • Contra-indications for phlebotomy (e.g. phlebitis) • Underwent treatment for current complaints for the last 6 weeks (e.g. physiotherapy, manual therapy, GP etc.) • Having mental health disorders (> 74 points on the MHI-5) • Taken one of the following medication for the last 6 weeks: corticosteroids (e.g. prednisone), immunomodulatory medication (e.g. methotrexate, infliximab etc.) and the use of botox for the last 3 months. • Taken one of the following medication: NSAID’s (e.g. diclofenac, ibuprofen, naproxen etc.), Aspirin, Simvastatin (58) for the last two weeks. • Having one of the following medical diseases o Neurological disorders (e.g. MS, myelopathie, cervical stenosis etc.) o Traumatic disorders (e.g. cervical fracture, surgery in the neck area etc.) o Having a history of malignity o Rheumatic or inflammatory disorders (e.g. Spondylitis Ankylpoetica, Crohn disease, sarcoidosis, colitis ulcerous, rheumatic arthritis, COPD, spastic colon, psoriasis etc.) o Cardiac diseases (e.g. history of myocardial infarction, abnormal heart rhythms) o Allergic reaction or auto immune diseases (e.g. type 1 diabetic, hay fever) o Metabolic disorders (e.g. type 2 diabetic) o Endocrinology disorders (e.g. Cushing Syndrome) o Haematological disorders (e.g. clothing problem) o Psychological/psychiatric disorders (e.g. depression, current high stress, Alzheimer disease) o Physical trauma for the last six weeks o Having the flue
Additional exclusion criteria for research question (3)(4) • Benzodiazepine (60) and opioid (61) use for the last six weeks. • Negative SPURLIN (62) and/or neurodynamic testing (62) (ULTTmedianus). • MRI contraindications, (e.g. claustrophobia, inability to lie still in the scanner or metal objects in or around the body) • Inability to undergo PET-CT with administration of radioligand [นนC]-R-PK11195. • Significant radiation exposure such that inclusion in this study will take the total dose >10mSv within the preceding 12 months. • In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/d • Current participation in another clinical trial. • Previous participation in a PET-CT study in the last 12 months.
Control group (research question (1)) A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy or postpartum for 9 months • Contra-indications for phlebotomy (e.g. phlebitis) • Having mental health disorders (> 74 points on the MHI-5) • Taken one of the following medication for the last 6 weeks: corticosteroids (e.g. prednisone), immunomodulatory medication (e.g. methotrexate, infliximab etc.) and the use of botox for the last 3 months. • Taken one of the following medication: NSAID’s (e.g. diclofenac, ibuprofen, naproxen etc.), Aspirin, Simvastatin (58) for the last two weeks. • Having one of the following medical diseases o Neurological disorders (e.g. MS, myelopathie, cervical stenosis etc.) o Traumatic disorders (e.g. cervical fracture, surgery in the neck area etc.) o Having a history of malignity o Rheumatic or inflammatory disorders (e.g. Spondylitis Ankylpoetica, Crohn disease, sarcoidosis, colitis ulcerous, rheumatic arthritis, COPD, spastic colon, psoriasis etc.) o Cardiac diseases (e.g. history of myocardial infarction, abnormal heart rhythms) o Allergic reaction or auto immune diseases (e.g. type 1 diabetic, hay fever) o Metabolic disorders (e.g. type 2 diabetic) o Endocrinology disorders (e.g. Cushing Syndrome) o Haematological disorders (e.g. clothing problem) o Psychological/psychiatric disorders (e.g. depression, current high stress, Alzheimer disease) o Physical trauma for the last six weeks o Having the flue
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-apr-2018
- planned closingdate1-okt-2019
- Target number of participants150
- InterventionsPatients with non-specific neck pain in study 2 who are allocated to the intervention group will receive a single highvelocity low-amplitude distraction manipulation at the cervico-thoracic region (C7-T4) and a low-velocity low-amplitude cervical mobilization at all of the restricted cervical segments (C0-C7). The intervention in study (3) consists of cervical lateral glide techniques, neural mobilization techniques, home exercises and brief education for the MP group and a soft neck collar with home exercises and instructions for the control group.
- Primary outcomeThe main study parameters in study (1) are potential differences in cytokine concentrations between the three groups. For study (2) the alteration in cytokine concentration from baseline to endpoint (immediately post-treatment and 120 minutes post-treatment) for the persistent non-specific neck pain group. In study (3), the main study parameter is the [นนC]-R-PK11195 binding potential (BP) in the brain and the [นนC]-RPK11195 standardised uptake value (SUV) in the cervical spinal cord and affected spinal root. [นนC]-R-PK11195 BP and SUV are assessments of microglia activation, and will be studied from baseline to endpoint (after 4 weeks of MP intervention or neck collar). In study (4), the main parameter is the Global Perceived Effect (GPE) scale score.
- Secondary outcomeThe secondary outcomes for study 1,2,3 are: differences in self-reported questionnaires (neck disability index (NDI), International physical activity questionnaire (IPAQ), painDETECT (PD-Q), treatment expectation, central sensitization inventory (CSI)) and Pain Pressure Threshold (PPT). Additional for study (2) differences in serum cortisol (baseline and immediately post-treatment) will be added as a secondary outcome. In study (3) potential differences of cytokine concentration (baseline and endpoint) will be studied. For study 1 and 2 phenotypic analysis of peripheral blood mononuclear cells will be compared.
- Timepoints
- Trial web sitehttps://project-motion.nl/index.html
- status[default]
- CONTACT FOR PUBLIC QUERIESDr. G.G.M. Scholten-Peeters
- CONTACT for SCIENTIFIC QUERIESDr. G.G.M. Scholten-Peeters
- Sponsor/Initiator Vrije Universiteit Amsterdam, Nederlandse Vereniging voor Manuele Therapie (NVMT)
- Funding
(Source(s) of Monetary or Material Support)
Vrije Universiteit Amsterdam, Nederlandse Vereniging voor Manuele Therapie (NVMT)
- Publications
- Brief summary Neck pain is a major public health problem alleged in its high prevalence, substantial impact on daily life and huge societal costs. Musculoskeletal Physiotherapy (MP) is an effective treatment for patients with persistent non-specific neck pain and cervical radiculopathy for reducing pain intensity. The effects of MP are often immediately noticeable after treatment. However, it is currently unknown which working mechanism might cause these effects. In persistent neck pain patients, the immune response - cytokines concentration - identified through whole blood lipopolysaccharide stimulation is elevated compared to healthy control. MP is able to attenuate the in vitro immune response in healthy volunteers. Thereby, a potential mechanism of MP might be attenuation of the immune response. In a subgroup of neck pain patients, namely patients with cervical radiculopathy, an additional and specific mechanism is expected. Increasing evidence indicates a significant role for neuroinflammation in the pathophysiology of nerve injury, especially for activation of resident macrophages of the central nervous system: the microglia. In animal models, MP seems to be able to attenuate glial cell activation. However, the role of glial cells in cervical radiculopathy patients and influence of MP on glial cells in vivo is unknown. Therefore, the overall aim of this study is to gain insight into the immune response in patients with neck pain and cervical radiculopathy, the influence of MP on this immune response and the role of neuroinflammation in patients with cervical radiculopathy
- Main changes (audit trail)
- RECORD18-jan-2018 - 28-jan-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl