Dry Needling in Patients With Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry needling
Sham Dry needling
Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion criteria
- Neck pain for at least three months (or more)
- An active trigger point in either the upper trapezius or the levator scapulae
Exclusion criteria
- Treatment for neck pain within the previous six months
- Neck Whiplash
- Fibromyalgia
- Infection in the area under treatment
- Pharmacological treatment with anti-coagulants
- Fear to needles
- Degenerative conditions
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
No Intervention
Arm Label
Manual therapy + Dry needling
Manual therapy + Sham Dry needling
Untreated control
Arm Description
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Manual therapy + Sham Dry needling: after a 7 days interval
Natural history of the condition
Outcomes
Primary Outcome Measures
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
Secondary Outcome Measures
Change in the Pressure Pain Threshold Measured by Algometer
Measured by algometer, with the standard measurement procedure
Change in the Cervical Range of Motion Measured by Goniometer
Measured by goniometer, with the standard measurement procedure
Change in the Neck Disability Index Questionnaire
Full Information
NCT ID
NCT02435966
First Posted
March 27, 2015
Last Updated
August 8, 2015
Sponsor
European University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02435966
Brief Title
Dry Needling in Patients With Chronic Neck Pain
Official Title
Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University of Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.
Detailed Description
A prospective single-blind randomized controlled trial, designed to assess the efficacy of dry needling in the treatment of chronic neck pain. The treatment regimes simulate the standard physiotherapy administered in real clinical settings. Patients in the intervention group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles). There are two control groups. In the first one, patients receive a combination of manual therapy and sham dry needling. In the second control group, patients receive no treatment in order to assess the natural history of the disease.
Patients receive two treatment sessions with an interval of 7 days and are followed up after 30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS). Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized questionnaire). Measurements are taken pre and post-test after the first and the second treatment sessions, plus once more at the follow-up, except for the Neck Disability Index (only at the beginning and after the second treatment). In the non-treated group, patients were measured at the same time intervals.
The sample size was calculated to detect a VAS difference of 2 points, the minimally clinically important difference established in the literature. Then it was doubled in order to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios, c/Valverde 26). Patients are randomized by a computer program.
Patients are explored for active trigger points in the upper trapezius and the levator scapulae. They should meet the criteria of identification established by Travell & Simons in their Trigger point manual. The investigators also seek for trigger points following Travell & Simons' pain maps for these two muscles, where they identify five trigger point areas. The investigators select the most active, taking pressure pain threshold measurements of all the active trigger point, normalizing the values according to normal thresholds for each of the five areas in the two muscles. The normal thresholds were assessed in a pilot study with healthy patients. The investigators administer either dry or sham dry needling to the most active (the one with the lowest pain threshold) throughout the trial.
Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a physiotherapist with 4 years of experience in the technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy + Dry needling
Arm Type
Experimental
Arm Description
Manual therapy + Dry needling: 2 sessions, after a 7 days interval
Arm Title
Manual therapy + Sham Dry needling
Arm Type
Other
Arm Description
Manual therapy + Sham Dry needling: after a 7 days interval
Arm Title
Untreated control
Arm Type
No Intervention
Arm Description
Natural history of the condition
Intervention Type
Device
Intervention Name(s)
Dry needling
Intervention Description
Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
Intervention Type
Device
Intervention Name(s)
Sham Dry needling
Intervention Description
Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Standard manual therapy in the upper trapezius or the levator scapulae
Primary Outcome Measure Information:
Title
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
Description
The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS
Time Frame
Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Secondary Outcome Measure Information:
Title
Change in the Pressure Pain Threshold Measured by Algometer
Description
Measured by algometer, with the standard measurement procedure
Time Frame
Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Title
Change in the Cervical Range of Motion Measured by Goniometer
Description
Measured by goniometer, with the standard measurement procedure
Time Frame
Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)
Title
Change in the Neck Disability Index Questionnaire
Time Frame
Pre-intervention (Day 1); after 2nd intervention (7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Neck pain for at least three months (or more)
An active trigger point in either the upper trapezius or the levator scapulae
Exclusion criteria
Treatment for neck pain within the previous six months
Neck Whiplash
Fibromyalgia
Infection in the area under treatment
Pharmacological treatment with anti-coagulants
Fear to needles
Degenerative conditions
Pregnancy
12. IPD Sharing Statement
Citations:
PubMed Identifier
32202124
Citation
Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
Results Reference
derived
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Dry Needling in Patients With Chronic Neck Pain
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