Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion

Somatic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01123226
• Other study ID #: AECC05052010
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 13, 2010
• Last updated: May 13, 2010
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2010
• Source: Anglo-European College of Chiropractic
• Contact: Hugh A Gemmell, DC, EdD
• Phone: 44 1202436200
• Email: hgemmell[@]aecc.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatic Dysfunction
• Spinal Manipulable Lesion

Intervention

Procedure:
• spinal manipulation
A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint
• trigger point therapy
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.

Locations

Country	Name	City	State
United Kingdom	Anglo-European College of Chiropractic	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Anglo-European College of Chiropractic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of spinal manipulable lesion	Dichotomous data either lesion is corrected or not.	Immediate effect of one treatment	No
Secondary	Change in pressure pain threshold over the involved spinous process	The point at which sensation changes from that of pressure to pain is measured in Kg/cm2	Immediate effect of one treatment	No