Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion

Relative Effectiveness of Trigger Point Therapy Compared to Spinal Manipulation in Correcting a Thoracic Spinal Manipulable Lesion in Subjects With Mechanical Thoracic Back Pain: a Randomised Trial

There will be no difference between trigger point therapy and spinal manipulation in correcting a spine joint dysfunction in the back

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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

Study Locations

    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH5 2DF
        • Anglo-European College of Chiropractic
        • Contact:
        • Sub-Investigator:
          • Jacqueline Richards, MChiro

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mechanical thoracic back pain
  • age 18-64
  • presence of at least one spinal manipulable lesion
  • presence of a trigger point associated with the spinal manipulable lesion
  • able to lie prone on a treatment table for 15 minutes

Exclusion Criteria:

  • absolute contraindications to spinal manipulation
  • specific thoracic back pain
  • bleeding diathesis, use of anticoagulants, long-term corticosteroid use
  • involved in litigation for thoracic back pain
  • inability to read or write English fluently
  • treatment with manipulation or myofascial therapy within past three days

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diversified HVLA spinal manipulation
A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint
Active Comparator: Trigger point pressure release
The thumb will apply firm pressure to a trigger point in the paravertebral multifidus and rotatores muscles associated with the spine joint dysfunction using the barrier approach. This will be held until the barrier releases and this will continue until the trigger point is inactivated or 3 minutes has passed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of spinal manipulable lesion
Time Frame: Immediate effect of one treatment
Dichotomous data either lesion is corrected or not.
Immediate effect of one treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pressure pain threshold over the involved spinous process
Time Frame: Immediate effect of one treatment
The point at which sensation changes from that of pressure to pain is measured in Kg/cm2
Immediate effect of one treatment

Collaborators and Investigators

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

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

September 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • AECC05052010

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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