- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927977
Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain
Dry-needling Added to Physical Therapy for Treating Patients With Chronic Non-specific Neck Pain: a Randomized Controlled Trial
Study Overview
Detailed Description
Background: Neck pain is a costly and high prevalent problem. Current evidences show that pain education, exercises and manual therapy are recommended to treat patients with chronic non-specific neck pain, but the use of dry needling has not been studied adequately when in combination with these therapies.
Previous trials have shown that dry needling have effectiveness in reducing neck pain in the short and medium term. However, these studies have some limitations as a small sample size and follow-up time reduced. A clinical trial with multimodal treatment method and consistent with clinical practice is needed to determine the effects of dry needling on individuals with non-specific neck pain.
Purpose: The purpose of this randomized clinical trial is to verify the effectiveness of the addition of the dry needling in individuals with non-specific neck pain who receive a multimodal physical therapy rehabilitation program and compare to individuals who received the multimodal physical therapy rehabilitation program without the use of the dry needling.
Design: a randomized single blind placebo controlled trial will be conducted trial in accordance with the CONSORT guidelines. Patients (n=116) with non-specific neck pain will be randomized to receive 1) pain education, manual therapy, and exercise (n=58) or 2) pain education, manual therapy, exercise and dry needling (n=58). Participants will receive 4-6 treatments during 4 weeks. Clinical outcomes (pain intensity, disability,global perceived effect, self-efficacy, quality of sleep and catastrophizing) will be obtained at follow-up appointments at four, twelve and twenty-four weeks after randomisation.
Methods: The primary outcome will be pain (measured by 11-point numerical pain rating scale) and disability (measured by the Neck Disability Index) measure four weeks after randomization. Secondary outcome will be pain and disability in twelve and twenty-four weeks after randomization and global perceived effect (measured by global perceived rating scale), self-efficacy (measured by pain self-efficacy questionnaire), quality of sleep (measure by Pittsburgh quality index), catastrophizing (measure by pain catastrophizing scale) measured four weeks, twelve weeks and twenty-four weeks after randomization and and registration of adverse events (24h, 27h and four weeks after randomization).
Data Analysis: All outcomes will be assessed following intention-to-treat principles. For each outcome, linear mixed models will be employed containing terms for participant, treatment center, group, time and group by time interaction. Known prognostic factors for increased disability in chronic neck pain will be treated as potential confounders and, in the presence of group imbalance despite random allocation, they will be treated as covariates for all outcomes. For the primary outcomes, a p < 0.05 will be considered statistically significant. For all secondary outcomes, a p < 0.01 will be considered statistically significant.
Significance: the results of this study will provide new information about the clinical application of dry needling in additional component for the management of non-specific neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil
- UFCSPA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- able to speaking and reading in Portuguese, severity of the symptoms at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index.
Exclusion Criteria:
- history of whiplash associated injuries, fibromyalgia, cervical spine symptoms of radiculopathy or myelopathy, use of anticoagulant medication, pregnancy, history of spinal surgeries and "red flags" (spinal fracture, inflammatory diseases, tumor, fracture, rheumatoid arthritis, osteoporosis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy.
Participants will receive 4-6 treatments during 4 weeks.
|
Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy.
Participants will receive 4-6 treatments during 4 weeks.
Other Names:
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Experimental: dry needling
Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles.
Participants will receive 4-6 treatments during 4 weeks.
Participants will receive 4-6 treatments during 4 weeks.
|
Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles.
Participants will receive 4-6 treatments during 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: 4 weeks after randomisation
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measured by 11-point numeric rating scale
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4 weeks after randomisation
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disability
Time Frame: 4 weeks after randomisation
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measured by neck disability index
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4 weeks after randomisation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: 12, 24 weeks after randomisation
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measured by 11-point numeric rating scale
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12, 24 weeks after randomisation
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disability
Time Frame: 12, 24 weeks after randomisation
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measured by neck disability index
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12, 24 weeks after randomisation
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global perceived effect
Time Frame: 4,12, 24 weeks after randomisation
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measured by global perceived rating scale
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4,12, 24 weeks after randomisation
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quality of sleep
Time Frame: 4,12, 24 weeks after randomisation
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measure by Pittsburgh quality index
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4,12, 24 weeks after randomisation
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catastrophizing
Time Frame: 4,12, 24 weeks after randomisation
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measure by pain catastrophizing scale
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4,12, 24 weeks after randomisation
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self-efficacy
Time Frame: 4,12, 24 weeks after randomisation
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measured by The Pain Self-Efficacy Questionnaire
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4,12, 24 weeks after randomisation
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adverse events
Time Frame: 24h, 72h and four weeks after randomisation
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record of the adverse events
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24h, 72h and four weeks after randomisation
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Collaborators and Investigators
Investigators
- Principal Investigator: Fábio F Stieven, Master, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRY01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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