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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual therapy + Dry needling | Experimental | Manual therapy + Dry needling: 2 sessions, after a 7 days interval |
|
| Manual therapy + Sham Dry needling | Other | Manual therapy + Sham Dry needling: after a 7 days interval |
|
| Untreated control | No Intervention | Natural history of the condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry needling | Device | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pressure Pain Threshold Measured by Algometer | Measured by algometer, with the standard measurement procedure | Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) |
| Change in the Cervical Range of Motion Measured by Goniometer |
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Inclusion criteria
Exclusion criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32202124 | Derived | 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. |
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No significant event here
Recruitment took place between May 2013 and June 2014 at Physios, a private physiotherapy practice in central Madrid (Spain)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Untreated Control | Natural history of the condition |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) |
|
30 days, from intervention 1 to follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gracia M. Gallego, M.Sc. | Physios & Universidad Europea de Madrid | +34 609036607 | gracia.maria.gallego@gmail.com |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Sham Dry needling | Device | 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 | Other | Standard manual therapy in the upper trapezius or the levator scapulae |
|
Measured by goniometer, with the standard measurement procedure |
| Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) |
| Change in the Neck Disability Index Questionnaire | Pre-intervention (Day 1); after 2nd intervention (7 days) |
| BG001 |
| 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 |
| BG002 | Untreated Control | Natural history of the condition |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Visual Analogue Scale | Mean | Standard Deviation | units on a scale |
|
| Pressure Pain Threshold at the most active trigger point | Mean | Standard Deviation | kg/cm2 |
|
| Range of Motion (Neck): Rotation Left | Mean | Standard Deviation | degrees |
|
| Range of Motion (Neck): Rotation Rigth | Mean | Standard Deviation | degrees |
|
| Range of Motion (Neck): Flexion | Mean | Standard Deviation | degrees |
|
| Range of Motion (Neck): Extension | Mean | Standard Deviation | degrees |
|
| Range of Motion (Neck): Inclination Left | Mean | Standard Deviation | degrees |
|
| Range of Motion (Neck): Inclination Rigth | Mean | Standard Deviation | degrees |
|
| OG001 | 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 |
| OG002 | Untreated Control | Natural history of the condition |
|
|
| Secondary | Change in the Pressure Pain Threshold Measured by Algometer | Measured by algometer, with the standard measurement procedure | Not Posted | Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) |
| Secondary | Change in the Cervical Range of Motion Measured by Goniometer | Measured by goniometer, with the standard measurement procedure | Not Posted | 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 | Not Posted | Pre-intervention (Day 1); after 2nd intervention (7 days) |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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 | 0 | 54 | 0 | 54 |
| EG002 | Untreated Control | Natural history of the condition | 0 | 30 | 0 | 30 |
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