Neck Pain
Conditions
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
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)
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
Standard manual therapy in the upper trapezius or the levator scapulae
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days | Pre-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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Pressure Pain Threshold Measured by Algometer | Pre-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 Goniometer | Pre-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 Questionnaire | Pre-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
| Arm | Count |
|---|---|
| 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 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Manual Therapy + Sham Dry Needling | Total | Manual Therapy + Dry Needling | Untreated Control |
|---|---|---|---|---|
| Age, Continuous | 34.64 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 point | 1.88 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): Extension | 55.67 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): Flexion | 69.24 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 Left | 55.43 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 Rigth | 49.03 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 Left | 73.81 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 Rigth | 74.60 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 Participants | 80 Participants | 34 Participants | 16 Participants |
| Sex: Female, Male Male | 24 Participants | 51 Participants | 13 Participants | 14 Participants |
| Visual Analogue Scale | 6.17 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 54 | 0 / 30 |
| serious Total, serious adverse events | 0 / 47 | 0 / 54 | 0 / 30 |
Outcome results
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Therapy + Dry Needling | Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days | 1.77 units on a scale | Standard Deviation 1.38 |
| Manual Therapy + Sham Dry Needling | Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days | 3.34 units on a scale | Standard Deviation 1.92 |
| Untreated Control | Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days | 8.83 units on a scale | Standard Deviation 1.64 |
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)
Change in the Neck Disability Index Questionnaire
Time frame: Pre-intervention (Day 1); after 2nd intervention (7 days)
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)