NCT02883634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

August 25, 2016

Last Update Submit

September 24, 2019

Conditions

Low Back Pain

Keywords

Back painspinal manipulation

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

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

    4 weeks

Secondary Outcomes (4)

  • Pain Intensity

    3 and 6 months after randomization

  • Disability

    4 weeks, 3 and 6 months after randomization

  • Global Impression of Recovery

    4 weeks, 3 and 6 months after randomization

  • Pressure Pain Threshold

    4 weeks after randomization

Study Arms (2)

specific manipulation

EXPERIMENTAL

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

Other: Specific manipulation

non-specific manipulation

EXPERIMENTAL

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

Interventions

Specific manipulationOTHER

Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.

specific manipulation
Non-specific manipulationOTHER

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.

non-specific manipulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients with low back pain duration from 3 to 24 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Cidade de São Paulo

São Paulo, 03071-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 32660919DERIVED

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonardo Costa, PT, PhD

    Universidade Cidade de São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

April 3, 2017

Primary Completion

November 23, 2018

Study Completion

November 23, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

BR(1)