Neck Pain Clinical Trial
— CNPOfficial title:
Is Better the One Type of Manual Therapy Than Others for to Treat the Patients With Chronic Neck Pain? : A Randomized Clinical Trial
Verified date | October 2013 |
Source | Universidad Rey Juan Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | December 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical Diagnosis of Chronic neck pain Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Rey Juan Carlos | Alcorcon | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Rey Juan Carlos | Universidad Europea de Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction | The Global Rating Of Change Scale - GROC is also a commonly used scale in clinical research, particularly in patients with neck pain. It is designed to quantify the improvements or deterioration over time, and allows the patient to choose the aspects of life that he considers important. There is variability in the design of the scales, a systematic review in Cochrane quoted seven different designs in the eight studies using a scale of GROC. This scale goes from -7 (much worse) to +7 (much better) with 0 being the midpoint (equally). | The Patients will be followed for 12 weeks after treatment | Yes |
Other | Anxiety | All participants completed Spanish version 47 of trait subscale of State Trait Anxiety Inventory (STAI-T. The STAI-T has been found to possess adequate reliability (alpha coefficients of 0.93, test-retest reliability of 0.80) and validity. | pre-treatment | No |
Other | Depression | The level of depressive symptomatology was measured by the Spanish version50 of Beck depression Inventory (BDI-II), a self-report measure which assess affective, cognitive, and somatic symptoms of depression. The BDI has shown good internal consistency both in original sample (alpha coefficient 0.90) and in Spanish population (alpha coefficient 0.92). In addition, both versions has an adequate validity | pre-treatment | No |
Other | Kinesiophobia | The Tampa Scale for Kinesiophobia, developed by Miller was used to assess fear of movement and injury. We used the original 17-items version, which has showed good psychometric guarantees. | Pre-treatment | No |
Other | Catastrophizing | To evaluate the subject's propensity to catastrophize about pain we used the Spanish version of Pain Catastrophizing Scale (PCS). This scale is a 13-item questionnaire designed to measure the three components of catastrophizing: rumination, magnification and helplessness, resulting this evaluation in a unique score | Pre-Treatment | No |
Primary | 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. | The Patients will be followed for 12 weeks after treatment | Yes |
Secondary | 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. | The Patients will be followed for 12 weeks after treatment | Yes |
Secondary | 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. | The Patients will be followed for 12 weeks after treatment | No |
Secondary | 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. | pre-treatment and post-treatment | No |
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