NCT02752620

Brief Summary

This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

April 23, 2016

Last Update Submit

October 11, 2016

Conditions

Low Back Pain

Keywords

osteopathic manipulative treatmentChronic nonspecific low back painlow back pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    VAS (VISUAL ANALOGUE SCALE)

    5 weeks

Secondary Outcomes (3)

  • Disability

    5 weeks

  • kinesiophobia

    5 weeks

  • Depression

    5 weeks

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

We selected two types of osteopathic techniques for this study: Technical articulation: rhythmic technique with low speed in which the goal is the full gain range of motion. Myofascial techniques (Neuromuscular): techniques involving lateral stretching, linear, deep pressures and pulls of the origins and insertions aiming at a myofascial relaxation. Sacroiliac articulatory technique; Dorsal articulatory technique; Lumbar paraspinal muscles stretching technique; Lumbar myofascial technique (inhibitory).

Other: Osteopathic Manipulative Treatment

Exercise Therapy

ACTIVE COMPARATOR

2 types of therapeutic exercises techniques were used: * Stabilization exercises * Stretches Stabilization exercises: Bridge on the ball 10 - 15 sec Side plank 10 - 15 sec Front board 10 - 15 sec active mobilization lumbopelvic 3 x 6 rep Squats with the ball on the wall 3 x 8 rep Static-passive stretch (2 x 30 sec): Paraspinal; Abdominals; Quadratus lumborum; Hip extenders; Hip flexors; Hip abductors; Hip adductors.

Other: Exercise Therapy

Interventions

Osteopathic Manipulative TreatmentOTHER
Osteopathic Manipulative Treatment
Exercise TherapyOTHER
Exercise Therapy

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain

You may not qualify if:

  • Subjects who have spine fractures,
  • Dislocations
  • Ligament ruptures
  • Muscle ruptures
  • Skin lacerations
  • Sacroiliitis
  • Vertebral osteomyelitis
  • Infection
  • Disc herniations with radicular symptoms
  • Rheumatic disorders
  • Cauda equina syndrome
  • Tumors
  • Referred pain visceral
  • Red flags
  • Lower limb discrepancy greater than 2 cm
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Estácio de Sá University

Rio de Janeiro, Rio de Janeiro, 21, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, OsteopathicExercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Frederico Meirelles, Master /PT

    UERJ

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 23, 2016

First Posted

April 27, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)