Specific or Non-Specific Manipulation for Patients With Back Pain

Universidade Cidade de Sao Paulo

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Non-specific manipulation; Other: Specific manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02883634

UNICID10

Details and patient eligibility

About

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.

Full 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).

Enrollment: 148 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

specific manipulation

Experimental group

Description:

Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination.

Treatment:

Other: Specific manipulation

non-specific manipulation

Experimental group

Description:

Participants allocated to group "non-specific manipulation" will have their upper thoracic spine manipulated (also known as "global manipulation") regardless of the previous clinical examination.

Treatment:

Other: Non-specific manipulation