Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Universidade Cidade de Sao Paulo
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Pain Intensity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
Detailed Description
To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization. 148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).
Investigators
Ronaldo Fernando de Oliveira
PhD Student
Universidade Cidade de Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Patients with low back pain duration from 3 to 24 months.
- •Exclusion criteria:
- •Patients with a pain duration lower than 3 months and higher than 24 months.
- •Patients with nerve root compromise or with serious spinal pathology,
- •Pregnant patients,
- •Previous back surgery
- •Patients with any contra-indication to spinal manipulation.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 4 weeks
Pain intensity will be measured using a 0-10 numerical rating scale
Secondary Outcomes
- Pain Intensity(3 and 6 months after randomization)
- Pressure Pain Threshold(4 weeks after randomization)
- Disability(4 weeks, 3 and 6 months after randomization)
- Global Impression of Recovery(4 weeks, 3 and 6 months after randomization)