Clinical trial NCT02883634: Specific or Non-Specific Manipulation for Patients With Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Back pain
spinal manipulation
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 3 and 6 months after randomization
measure: Disability
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Global Impression of Recovery
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Pressure Pain Threshold
timeFrame: 4 weeks after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Cidade de São Paulo
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Leonardo Costa, PT, PhD
role: STUDY_CHAIR
References:
citation: de Oliveira RF, Costa LOP, Nascimento LP, Rissato LL. Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial. J Physiother. 2020 Jul;66(3):174-179. doi: 10.1016/j.jphys.2020.06.007. Epub 2020 Jul 10.