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Dry Needling in Patients With Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT02435966
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Gracia Gallego Sendarrubias, European University of Madrid

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Neck Pain
Interventions Device: Dry needling
Device: Sham Dry needling
Other: Manual therapy
Enrollment 131
Recruitment Details Recruitment took place between May 2013 and June 2014 at Physios, a private physiotherapy practice in central Madrid (Spain)
Pre-assignment Details No significant event here
Arm/Group Title Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Hide Arm/Group Description

Manual therapy + Dry needling: 2 sessions, after a 7 days interval

Dry needling: 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)

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Manual therapy + Sham Dry needling: after a 7 days interval

Sham Dry needling: 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

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Natural history of the condition
Period Title: Overall Study
Started 47 54 30
First Intervention 47 54 30
Second Intervention 47 53 30
Follow-up 47 53 30
Completed 47 53 30
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control Total
Hide Arm/Group Description

Manual therapy + Dry needling: 2 sessions, after a 7 days interval

Dry needling: 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)

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Manual therapy + Sham Dry needling: after a 7 days interval

Sham Dry needling: 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

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Natural history of the condition Total of all reporting groups
Overall Number of Baseline Participants 47 54 30 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 54 participants 30 participants 131 participants
34.13  (7.64) 34.64  (8.88) 31.37  (9.33) 34.62  (8.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 54 participants 30 participants 131 participants
Female
34
  72.3%
30
  55.6%
16
  53.3%
80
  61.1%
Male
13
  27.7%
24
  44.4%
14
  46.7%
51
  38.9%
Visual Analogue Scale  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 54 participants 30 participants 131 participants
6.66  (1.37) 6.17  (1.60) 6.57  (1.33) 6.44  (1.46)
Pressure Pain Threshold at the most active trigger point  
Mean (Standard Deviation)
Unit of measure:  Kg/cm2
Number Analyzed 47 participants 54 participants 30 participants 131 participants
1.75  (0.37) 1.88  (0.52) 1.83  (0.43) 1.82  (0.45)
Range of Motion (Neck): Rotation Left  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
71.78  (17.73) 73.81  (11.82) 78.20  (11.21) 74.09  (14.23)
Range of Motion (Neck): Rotation Rigth  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
74.27  (18.10) 74.60  (15.31) 78.20  (11.21) 76.24  (15.49)
Range of Motion (Neck): Flexion  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
67.89  (13.53) 69.24  (11.05) 65.96  (8.82) 68.00  (11.56)
Range of Motion (Neck): Extension  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
52.31  (14.56) 55.67  (11.54) 59.66  (9.30) 55.38  (12.50)
Range of Motion (Neck): Inclination Left  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
53.63  (10.83) 55.43  (10.99) 52.43  (8.44) 54.09  (10.39)
Range of Motion (Neck): Inclination Rigth  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 47 participants 54 participants 30 participants 131 participants
47.72  (14.28) 49.03  (13.09) 45.63  (6.78) 47.77  (12.40)
1.Primary Outcome
Title Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Hide Arm/Group Description:

Manual therapy + Dry needling: 2 sessions, after a 7 days interval

Dry needling: 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)

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Manual therapy + Sham Dry needling: after a 7 days interval

Sham Dry needling: 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

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Natural history of the condition
Overall Number of Participants Analyzed 47 54 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.77  (1.38) 3.34  (1.92) 8.83  (1.64)
2.Secondary Outcome
Title Change in the Pressure Pain Threshold Measured by Algometer
Hide 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)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in the Cervical Range of Motion Measured by Goniometer
Hide 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)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in the Neck Disability Index Questionnaire
Hide Description [Not Specified]
Time Frame Pre-intervention (Day 1); after 2nd intervention (7 days)
Outcome Measure Data Not Reported
Time Frame 30 days, from intervention 1 to follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Hide Arm/Group Description

Manual therapy + Dry needling: 2 sessions, after a 7 days interval

Dry needling: 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)

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Manual therapy + Sham Dry needling: after a 7 days interval

Sham Dry needling: 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

Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae

Natural history of the condition
All-Cause Mortality
Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/54 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Manual Therapy + Dry Needling Manual Therapy + Sham Dry Needling Untreated Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/54 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gracia M. Gallego, M.Sc.
Organization: Physios & Universidad Europea de Madrid
Phone: +34 609036607
EMail: gracia.maria.gallego@gmail.com
Layout table for additonal information
Responsible Party: Gracia Gallego Sendarrubias, European University of Madrid
ClinicalTrials.gov Identifier: NCT02435966    
Other Study ID Numbers: University European of Madrid
First Submitted: March 27, 2015
First Posted: May 6, 2015
Results First Submitted: August 8, 2015
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015