Specific or Non-Specific Manipulation for Patients With Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Non-specific manipulation; Other: Specific manipulation

• Registration Number: NCT02883634
• Lead Sponsor: Universidade Cidade de Sao Paulo

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).

Study Timeline

• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Study Start: 2017-04-03
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-specific manipulation	Non-specific manipulation	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.
specific manipulation	Specific manipulation	Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	4 weeks	Pain intensity will be measured using a 0-10 numerical rating scale

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	3 and 6 months after randomization	Pain intensity will be measured using a 0-10 numerical rating scale
Pressure Pain Threshold	4 weeks after randomization	Pressure Pain Threshold will be measure by a digital pressure algomoter
Disability	4 weeks, 3 and 6 months after randomization	Disability will be measured by the 0-24 Roland Morris Disability Questionnaire
Global Impression of Recovery	4 weeks, 3 and 6 months after randomization	Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale

Trial Locations

Locations (1)

Universidade Cidade de São Paulo; 🇧🇷 São Paulo, Brazil