NCT01123226

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

May 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

9 months

First QC Date

May 13, 2010

Last Update Submit

May 13, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correction of spinal manipulable lesion

    Dichotomous data either lesion is corrected or not.

    Immediate effect of one treatment

Secondary Outcomes (1)

  • Change in pressure pain threshold over the involved spinous process

    Immediate effect of one treatment

Study Arms (2)

Diversified HVLA spinal manipulation

EXPERIMENTAL
Procedure: spinal manipulation

Trigger point pressure release

ACTIVE COMPARATOR
Procedure: trigger point therapy

Interventions

A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint

Diversified HVLA spinal manipulation

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.

Trigger point pressure release

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anglo-European College of Chiropractic

Bournemouth, Dorset, BH5 2DF, United Kingdom

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Central Study Contacts

Hugh A Gemmell, DC, EdD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 14, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations