Specific or Non-Specific Manipulation for Patients With Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883634
• Other study ID #: UNICID10
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: November 23, 2018

Study information

• Verified date: September 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Specific manipulation
Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.
• Non-specific manipulation
Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.

Locations

Country	Name	City	State
Brazil	Universidade Cidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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