Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dry needling
acupuncture needle 0,25 x 40mm
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial Pain Syndrome, Dry needling, Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- Assymetric shoulder pain (VAS on painful side : VAS on non painful side > 2:1)
- Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.
- Chronic pain, with duration of at least 3 months and VAS > 40/100
- Patients with pain at least 4 days in a week
- Patients without neurological pain, as in DN4 score less than 4
- Age over 18 years
- Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study
- Patients who read, understood and signed the Free and Clarified Consent Term
Exclusion Criteria:
- Patients with major depression, according to DSM-IV criteria
- History of bipolar mood disorder, panic syndrome or psychosis
- Intermittent pain history
- Refusal to sing the Consent Term
- Patients not able to attend all the follow-ups
- Patients with another pain syndrome in shoulders
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Dry needling
Sham needling
Arm Description
Dry needling for myofascial pain syndrome, in the trapezius muscle.
Superficial dry needling in the trapezius muscle
Outcomes
Primary Outcome Measures
Analgesic effects of dry needling
Maximum, average and lowest pain will be evaluated daily 7 days before the treatment, on the day of the treatment, and also 7 days after the treatment is done.
Secondary Outcome Measures
Neurologic effects of dry needling
Tactile, mechanical, static and thermal sensitivity will be evaluated with thermal quantitative sensorial testing, as well as hyperalgesia. The painful area will also be mapped to compara before and after treatment results.
Full Information
NCT ID
NCT02179320
First Posted
June 27, 2014
Last Updated
May 2, 2018
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02179320
Brief Title
Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Official Title
Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients.
Detailed Description
This study will be performed in patients with shoulder pain due to excess of nociception associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle trigger points.
Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S) (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will receive a sham treatment, with the needle inserted superficially in the skin, without reaching the muscle underneath it.
The duration and pain elicited during active and sham dry needling will be controlled for. Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0) and seven days after the procedure (D+7).
Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more accurately evaluate their daily pain before and after the treatment.
For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile, mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS), and also mapping of the painful area, before and after treatment in both D0 and D+7.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Myofascial Pain Syndrome, Dry needling, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Active Comparator
Arm Description
Dry needling for myofascial pain syndrome, in the trapezius muscle.
Arm Title
Sham needling
Arm Type
Sham Comparator
Arm Description
Superficial dry needling in the trapezius muscle
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
Intervention Type
Device
Intervention Name(s)
acupuncture needle 0,25 x 40mm
Primary Outcome Measure Information:
Title
Analgesic effects of dry needling
Description
Maximum, average and lowest pain will be evaluated daily 7 days before the treatment, on the day of the treatment, and also 7 days after the treatment is done.
Time Frame
Within the first 7 days after treatment
Secondary Outcome Measure Information:
Title
Neurologic effects of dry needling
Description
Tactile, mechanical, static and thermal sensitivity will be evaluated with thermal quantitative sensorial testing, as well as hyperalgesia. The painful area will also be mapped to compara before and after treatment results.
Time Frame
Within the first 7 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Assymetric shoulder pain (VAS on painful side : VAS on non painful side > 2:1)
Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.
Chronic pain, with duration of at least 3 months and VAS > 40/100
Patients with pain at least 4 days in a week
Patients without neurological pain, as in DN4 score less than 4
Age over 18 years
Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study
Patients who read, understood and signed the Free and Clarified Consent Term
Exclusion Criteria:
Patients with major depression, according to DSM-IV criteria
History of bipolar mood disorder, panic syndrome or psychosis
Intermittent pain history
Refusal to sing the Consent Term
Patients not able to attend all the follow-ups
Patients with another pain syndrome in shoulders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Andrade, M.D., P.h.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juliana T Toma, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irina Raicher, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manoel J Teixeira, M.D., P.h.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helena H Kaziyama, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
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Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
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