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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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
Arm/Group Description	Manual therapy + Dry needling: 2 se...	Manual therapy + Sham Dry needling:...	Natural history of the condition
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

Baseline Characteristics

Arm/Group Title		Manual Therapy + Dry Needling	Manual Therapy + Sham Dry Needling	Untreated Control	Total
Arm/Group Description		Manual therapy + Dry needling: 2 se...	Manual therapy + Sham Dry needling:...	Natural history of the condition	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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)

Outcome Measures

1.Primary Outcome


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 ...
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Manual Therapy + Dry Needling	Manual Therapy + Sham Dry Needling	Untreated Control
Arm/Group Description:	Manual therapy + Dry needling: 2 se...	Manual therapy + Sham Dry needling:...	Natural history of the condition
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
Description	Measured by algometer, with the standard measurement procedure
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
Description	Measured by goniometer, with the standard measurement procedure
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Pre-intervention (Day 1); after 2nd intervention (7 days)

Outcome Measure Data Not Reported

Adverse Events

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
Arm/Group Description	Manual therapy + Dry needling: 2 se...	Manual therapy + Sham Dry needling:...	Natural history of the condition
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	--/--	--/--	--/--
Serious Adverse Events 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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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