Spinal Manipulation Effectiveness in Spinal Disorders

June 15, 2017 updated by: DAVID CRUZ DÍAZ

Spinal Manipulation Effectiveness in Pain, Disability and Range of Motion.

The aim of the present intervention study is to determine the effectiveness of manipulation techniques.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antonio Amat, PhD
  • Phone Number: +34953212121
  • Email: amamat@ujaen.es

Study Contact Backup

Study Locations

  • Spain
      • Jaen, Spain, 23009
        • University of Jaén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently suffering spinal related pain (neck, thoracic or lumbar).
  • Not receiving additional treatment for the treated condition.

Exclusion Criteria:

  • Presence of red flags such as tumors or infection.
  • Recent surgery.
  • Fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spinal manipulation
Spinal manipulation to the spine will be applied to participants enrolled in this group.
Other: Spinal Manipulation
Spinal manipulation based on orthopaedic manual therapy approach
Sham Comparator: Sham manipulation
Sham technique wich mimic the intervention manipulation with less force and different body location will be applied.
Other: Sham manipulation
Patients will receive simulated spinal manipulation without force application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogical scale
Time Frame: Change from baseline to 4 weeks and 6 months of follow up.
Pain was measured using a visual analogical scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate in the scale their current level of pain being higher values related with more intense pain
Change from baseline to 4 weeks and 6 months of follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: Change from baseline to 4 weeks and 6 months of follow up.
The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Change from baseline to 4 weeks and 6 months of follow up.
Range of Motion
Time Frame: Change from baseline to 4 weeks and 6 months of follow up.
The spinal range of motion will be assessed with a digital inclinometer which indicates the results in angular degrees.
Change from baseline to 4 weeks and 6 months of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DAVID CRUZ DÍAZ

Investigators

  • Principal Investigator: DAVID Curz DIAZ, PhD, University of Jaén

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2018

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ManipulationUja

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no intention to share the plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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