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Specific or Non-Specific Manipulation for Patients With Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Specific manipulation
Non-specific manipulation
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Back pain, spinal manipulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidade Cidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

specific manipulation

non-specific manipulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain Intensity
Pain intensity will be measured using a 0-10 numerical rating scale

Secondary Outcome Measures

Pain Intensity
Pain intensity will be measured using a 0-10 numerical rating scale
Disability
Disability will be measured by the 0-24 Roland Morris Disability Questionnaire
Global Impression of Recovery
Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale
Pressure Pain Threshold
Pressure Pain Threshold will be measure by a digital pressure algomoter

Full Information

First Posted
August 25, 2016
Last Updated
September 24, 2019
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02883634
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
November 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Back pain, spinal manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
specific manipulation
Arm Type
Experimental
Arm Description
Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination.
Arm Title
non-specific manipulation
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Specific manipulation
Intervention Description
Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.
Intervention Type
Other
Intervention Name(s)
Non-specific manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity will be measured using a 0-10 numerical rating scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity will be measured using a 0-10 numerical rating scale
Time Frame
3 and 6 months after randomization
Title
Disability
Description
Disability will be measured by the 0-24 Roland Morris Disability Questionnaire
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Global Impression of Recovery
Description
Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Pressure Pain Threshold
Description
Pressure Pain Threshold will be measure by a digital pressure algomoter
Time Frame
4 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Costa, PT, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Cidade de São Paulo
City
São Paulo
ZIP/Postal Code
03071-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are happy to share our data with researchers that would like to use it on an IPD.
Citations:
PubMed Identifier
32660919
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.
Results Reference
derived

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Specific or Non-Specific Manipulation for Patients With Back Pain

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