The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
- Conditions
- Neck Pain
- Interventions
- Other: Spinal ManipulationOther: Pain EducationOther: Sham
- Registration Number
- NCT02982369
- Lead Sponsor
- Santa Catarina Federal University
- Brief Summary
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Main complaint of Neck Pain for at least six (6) months;
- Score of at least 10 points in NDI (Neck Disability Index);
- Pain and / or restriction of cervical movements;
- Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
- The definition of the term Neck Pain follows the classification of TFNP.
- Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
- History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
- Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
- Red flags contraindicating spinal manipulation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spinal Manipulation Spinal Manipulation High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. Spinal Manipulation Pain Education High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. Pain Education Pain Education Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. Pain Education Sham Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
- Primary Outcome Measures
Name Time Method Pain Intensity 4 weeks after randomization Intensity of pain will be measured by the numeric pain rating scale (NPRS)
- Secondary Outcome Measures
Name Time Method Cytokines 4 weeks after randomization Level of concentration of pro and anti-inflammatory cytokines
Pressure Pain Threshold 4 weeks and 3 months after randomization Pressure pain Threshold will be measured with a digital algometer
Disability 4 weeks and 3 months after randomization Disability will be measured by the Neck Disability Index (NDI)
Fear Avoidance Beliefs 4 weeks and 3 months after randomization Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)
Health-related Quality of Life 4 weeks and 3 months after randomization Quality of Life will be measured by the 12-Item Health Survey (SF-12)
Kinesiophobia 4 weeks and 3 months after randomization Kinesiophobia will be measured byTampa Scale for Kinesiophobia
Pain Intensity 3 months after randomization Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Trial Locations
- Locations (1)
Santa Catarina Federal University
🇧🇷Florianopolis, Santa Catarina, Brazil