Specific or Non-Specific Manipulation for Patients With Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Specific manipulation; Other: Non-specific manipulation

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 03071-000
    • Universidade Cidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: specific manipulation; Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination.	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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity will be measured using a 0-10 numerical rating scale	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity will be measured using a 0-10 numerical rating scale	3 and 6 months after randomization
Disability	Disability will be measured by the 0-24 Roland Morris Disability Questionnaire	4 weeks, 3 and 6 months after randomization
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
Pressure Pain Threshold	Pressure Pain Threshold will be measure by a digital pressure algomoter	4 weeks after randomization

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Study Chair: Leonardo Costa, PT, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: spinal manipulation; Back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UNICID10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are happy to share our data with researchers that would like to use it on an IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No