NCT01608633

Brief Summary

Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

May 27, 2012

Last Update Submit

September 3, 2013

Conditions

Pain After Dry Needling

Outcome Measures

Primary Outcomes (1)

  • Pain

    Visual analogue scale

    72 hours

Secondary Outcomes (2)

  • Pain

    48 hours

  • Psychological factors

    72 hours after needling

Study Arms (2)

Spray and stretch

EXPERIMENTAL
Other: Spray and stretch

Control

NO INTERVENTION

Interventions

Spray and stretchOTHER

Physiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin.

Spray and stretch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects presenting latent trigger points in the trapezius muscle

You may not qualify if:

  • Subjects with active trigger points or absence of trigger points.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU San Pablo University

Madrid, Madrid, 28668, Spain

Location

MeSH Terms

Interventions

pentafluoropropane-tetrafluoroethane

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2012

First Posted

May 31, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

ES(1)