- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190890
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
December 5, 2017 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial Pain
The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
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 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS
Exclusion Criteria:
- Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling: 4 local twitch responses
Deep dry needling in the active myofascial trigger point in the upper trapezius muscle.
The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.
|
|
Experimental: Dry needling: 6 local twitch responses
Deep dry needling in the active myofascial trigger point in the upper trapezius muscle.
The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.
|
|
Experimental: Dry needling: Until no more local twitch responses elicited
Deep dry needling in the active myofascial trigger point in the upper trapezius muscle.
The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.
|
|
Active Comparator: Control
The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 1 week
|
Visual analog scale.
A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
|
1 week
|
Postneedling soreness
Time Frame: 1 week
|
Visual analog scale.
A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold
Time Frame: 1 week
|
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
|
1 week
|
Cervical range of motion
Time Frame: 1 week
|
The subjects sat in a chair and a CROM goniometer was placed over the head.
They were asked to perform active neck movements to the fullest extent of their mobility.
Each movement was recorded three times and the average value was calculated.
|
1 week
|
Neck disability
Time Frame: 1 week
|
Neck Disability Index questionnarie was completed.
|
1 week
|
Pain in cervical range of motion
Time Frame: 1 week
|
Pain in a numerical pain rating scale during all cervical movements was recorded.
|
1 week
|
Psychological factors
Time Frame: Pre-intervention
|
State Trait Anxiety Inventory (STAI-T)
|
Pre-intervention
|
Psychological factors
Time Frame: Pre-intervention
|
Beck Depression Inventory (BDI-II)
|
Pre-intervention
|
Psychological factors
Time Frame: Pre-intervention
|
Tampa Scale for Kinesiophobia
|
Pre-intervention
|
Psychological factors
Time Frame: Pre-intervention
|
Pain Catastrophizing Scale
|
Pre-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 11, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Actual)
December 6, 2017
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/2013
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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