Skip to content

Dry Needling in Patients With Chronic Neck Pain

Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02435966
Enrollment
131
Registered
2015-05-06
Start date
2013-05-31
Completion date
2015-03-31
Last updated
2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

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.

Interventions

DEVICEDry 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)

DEVICESham 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

OTHERManual therapy

Standard manual therapy in the upper trapezius or the levator scapulae

Sponsors

European University of Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 DaysPre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)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

MeasureTime frameDescription
Change in the Pressure Pain Threshold Measured by AlgometerPre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)Measured by algometer, with the standard measurement procedure
Change in the Cervical Range of Motion Measured by GoniometerPre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)Measured by goniometer, with the standard measurement procedure
Change in the Neck Disability Index QuestionnairePre-intervention (Day 1); after 2nd intervention (7 days)

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

Participants by arm

ArmCount
Manual Therapy + Dry Needling
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
47
Manual Therapy + Sham Dry Needling
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
54
Untreated Control
Natural history of the condition
30
Total131

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject010

Baseline characteristics

CharacteristicManual Therapy + Sham Dry NeedlingTotalManual Therapy + Dry NeedlingUntreated Control
Age, Continuous34.64 years
STANDARD_DEVIATION 8.88
34.62 years
STANDARD_DEVIATION 8.51
34.13 years
STANDARD_DEVIATION 7.64
31.37 years
STANDARD_DEVIATION 9.33
Pressure Pain Threshold at the most active trigger point1.88 kg/cm2
STANDARD_DEVIATION 0.52
1.82 kg/cm2
STANDARD_DEVIATION 0.45
1.75 kg/cm2
STANDARD_DEVIATION 0.37
1.83 kg/cm2
STANDARD_DEVIATION 0.43
Range of Motion (Neck): Extension55.67 degrees
STANDARD_DEVIATION 11.54
55.38 degrees
STANDARD_DEVIATION 12.5
52.31 degrees
STANDARD_DEVIATION 14.56
59.66 degrees
STANDARD_DEVIATION 9.3
Range of Motion (Neck): Flexion69.24 degrees
STANDARD_DEVIATION 11.05
68.00 degrees
STANDARD_DEVIATION 11.56
67.89 degrees
STANDARD_DEVIATION 13.53
65.96 degrees
STANDARD_DEVIATION 8.82
Range of Motion (Neck): Inclination Left55.43 degrees
STANDARD_DEVIATION 10.99
54.09 degrees
STANDARD_DEVIATION 10.39
53.63 degrees
STANDARD_DEVIATION 10.83
52.43 degrees
STANDARD_DEVIATION 8.44
Range of Motion (Neck): Inclination Rigth49.03 degrees
STANDARD_DEVIATION 13.09
47.77 degrees
STANDARD_DEVIATION 12.4
47.72 degrees
STANDARD_DEVIATION 14.28
45.63 degrees
STANDARD_DEVIATION 6.78
Range of Motion (Neck): Rotation Left73.81 degrees
STANDARD_DEVIATION 11.82
74.09 degrees
STANDARD_DEVIATION 14.23
71.78 degrees
STANDARD_DEVIATION 17.73
78.20 degrees
STANDARD_DEVIATION 11.21
Range of Motion (Neck): Rotation Rigth74.60 degrees
STANDARD_DEVIATION 15.31
76.24 degrees
STANDARD_DEVIATION 15.49
74.27 degrees
STANDARD_DEVIATION 18.1
78.20 degrees
STANDARD_DEVIATION 11.21
Sex: Female, Male
Female
30 Participants80 Participants34 Participants16 Participants
Sex: Female, Male
Male
24 Participants51 Participants13 Participants14 Participants
Visual Analogue Scale6.17 units on a scale
STANDARD_DEVIATION 1.6
6.44 units on a scale
STANDARD_DEVIATION 1.46
6.66 units on a scale
STANDARD_DEVIATION 1.37
6.57 units on a scale
STANDARD_DEVIATION 1.33

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 470 / 540 / 30
serious
Total, serious adverse events
0 / 470 / 540 / 30

Outcome results

Primary

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

Time frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)

ArmMeasureValue (MEAN)Dispersion
Manual Therapy + Dry NeedlingChange in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days1.77 units on a scaleStandard Deviation 1.38
Manual Therapy + Sham Dry NeedlingChange in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days3.34 units on a scaleStandard Deviation 1.92
Untreated ControlChange in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days8.83 units on a scaleStandard Deviation 1.64
Secondary

Change in the Cervical Range of Motion Measured by Goniometer

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)

Secondary

Change in the Neck Disability Index Questionnaire

Time frame: Pre-intervention (Day 1); after 2nd intervention (7 days)

Secondary

Change in the Pressure Pain Threshold Measured by Algometer

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)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026