NCT01796496

Brief Summary

The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2013

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

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 6, 2015

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

February 20, 2013

Last Update Submit

October 3, 2015

Conditions

Keywords

Low back pain.Manipulative therapy techniques.Randomized controlled trial.Chronic pain.

Outcome Measures

Primary Outcomes (1)

  • Roland Morris Disability Questionnaire (RMDQ)

    The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.

    At baseline, 3 weeks and 7 weeks

Secondary Outcomes (6)

  • Oswestry Disability Index (ODI)

    At baseline, 3 weeks and 7 weeks

  • Visual Analogue Scale (VAS)

    At baseline, 3 weeks and 7 weeks

  • Tampa Scale for Kinesiophobia (TSK)

    At baseline, 3 weeks and 7 weeks

  • Quality of Life

    At baseline, 3 weeks and 7 weeks

  • Isometric Resistance of Abdominal Muscles

    At baseline, 3 weeks and 7 weeks

  • +1 more secondary outcomes

Study Arms (2)

Manipulative Therapy Techniques

EXPERIMENTAL

Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.

Other: Manipulative Therapy Techniques

Functional Technique

ACTIVE COMPARATOR

Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.

Other: Functional Technique

Interventions

* Global Technical bilateral pelvis: The technique involves inserting a small spine rotation and make a slack in three stages. * Indirect technique of lumbar roll in rotation for bilateral L3: to reduce the slack and make the body drop simultaneously, together with a high speed contraction pectoral muscles and triceps, iliac crest leading caudad which produces a rotation of the vertebra underlying joint space opening. * Dog-technic on D12: this technique reduces the slack in the abdomen toward the hand in contact with D12. Next, the therapist conducted a thrust in the direction of the reduction.

Manipulative Therapy Techniques

The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique. Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively. These movements should be symmetrical and of equal duration in time.

Functional Technique

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Low back pain for ≥ 3 months.
  • Score ≥4 on the Roland Morris disability questionnaire.
  • No undergoing another physical therapy treatment.
  • Inability to achieve lumbar muscle flexion-relaxation in trunk flexion

You may not qualify if:

  • Clinical signs of radiculopathy.
  • Presence of lumbar stenosis.
  • Fibromyalgia.
  • Spondylolisthesis.
  • History of spinal surgery.
  • Treatment with corticosteroids in the past two weeks.
  • Disease of the central or peripheral nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (26)

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    PMID: 23159980BACKGROUND
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    PMID: 23047044BACKGROUND
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    PMID: 23047043BACKGROUND
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    PMID: 23040656BACKGROUND
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    PMID: 23018080BACKGROUND
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    PMID: 22972127BACKGROUND
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  • Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.

    PMID: 22925609BACKGROUND
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    PMID: 22904251BACKGROUND
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    PMID: 22858233BACKGROUND
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    PMID: 22802542BACKGROUND
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    PMID: 22796243BACKGROUND
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    PMID: 22739674BACKGROUND
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    PMID: 22703751BACKGROUND
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    PMID: 22658268BACKGROUND
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    PMID: 22622913BACKGROUND
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MeSH Terms

Conditions

Low Back PainChronic DiseaseChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Adelaida M Castro-Sánchez, PhD

    Universidad de Almeria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer-PhD

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 21, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

October 6, 2015

Record last verified: 2013-11

Locations