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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

Persistent non-specific neck pain (research question (1)(2)(3))
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.
* 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))
Inclusion
* Age between 18-65 years.
* Minimal score of 4 on the Numeric Pain Rating Scale.
* Pain should be present for a minimal of six weeks.
* 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 Criteria

Persistent non-specific neck pain (research question (1)(2)(3));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 for the last two weeks.
* Jet lag (within 7 days), ongoing shift work and hippocampal damage.
* 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)(3))
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 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 <br

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters in subprotocol (1) are potential differences in<br /><br>cytokine concentrations between the three groups.<br /><br>For subprotocol (2) the alteration in cytokine concentration from baseline to<br /><br>endpoint (immediately post-treatment and 120 minutes post-treatment) for the<br /><br>persistent non-specific neck pain group.<br /><br>In subprotocol (3), the main parameter is the Global Perceived Effect (GPE)<br /><br>scale score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes for subprotocol 1,2, are: differences in self-reported<br /><br>questionnaires (neck disability index (NDI), International physical activity<br /><br>questionnaire (IPAQ), painDETECT (PD-Q), central sensitization inventory (CSI))<br /><br>Visceral fat and Pain Pressure Threshold (PPT).<br /><br>Additional for subprotocol (2) differences in serum cortisol (baseline and<br /><br>immediately post-treatment) will be added as a secondary outcome.<br /><br>For subprotocol 1 and 2 phenotypic analysis of peripheral blood mononuclear<br /><br>cells will be compared.<br /><br>Subprotocol (2) the Association between painscore and change in immune<br /><br>response after the Intervention.</p><br>