The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pain Intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Spinal Manipulation (Other)
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.
Intervention: Pain Education (Other)
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.
Intervention: Pain Education (Other)
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.
Intervention: Sham (Other)
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 4 weeks after randomization
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Secondary Outcomes
- Pressure Pain Threshold(4 weeks and 3 months after randomization)
- Health-related Quality of Life(4 weeks and 3 months after randomization)
- Cytokines(4 weeks after randomization)
- Disability(4 weeks and 3 months after randomization)
- Fear Avoidance Beliefs(4 weeks and 3 months after randomization)
- Kinesiophobia(4 weeks and 3 months after randomization)
- Pain Intensity(3 months after randomization)
Investigators
Marcelo Anderson Bracht
Principal Investigator
Santa Catarina Federal University