Ultrasound-Guided Miniscalpel-Needle Release versus Dry Needling for Chronic Neck Pain: A Randomized Controlled Trial (2024)

2.1. Subjects

This study was approved by the Institutional Review Board of Renji Hospital (Shanghai, China) and registered in the Chinese Clinical Trial Register (ChiCTR-TRC-10001609). Data collection, analysis, and reporting were performed in compliance with the CONSORT guidelines [17]. Written informed consent was obtained from all participants.

Consecutive adult (≥18 years old) outpatients with chronic neck pain seeking medical treatment at the Department of Pain Management, Renji Hospital, from January 2009 to February 2010 were recruited. Eligibility was determined at the preliminary interview. For inclusion in the study, patients had to meet all the following criteria: chronic neck pain for more than three months; a score > 3 on a 10-point visual analogue scale (VAS); and the presence of trigger points in the neck. Trigger points were established based on both physical signs (hypersensitive bundle or nodule of muscle fibers harder than normal upon palpation) and ultrasound imaging (hyperechoic skin, hyperechoic marbled appearance of the muscle, and mixed echogenicity). Patients were excluded if they were pregnant or if they had a history of acupuncture, DN, MSN release, or vertebral column surgery. They were also excluded if they had any of the following conditions: protrusion or prolapse of one or more intervertebral discs with concurrent neurological symptoms; infectious spondylopathy; chronic neck pain caused by inflammatory, malignant, or autoimmune disease; congenital deformation of spine except slight lordosis or scoliosis; compression fracture caused by osteoporosis; spinal stenosis and spondylolysis or spondylolisthesis.

2.2. Pain Management

Patients were randomly assigned to receive either UG-MSN release or UG-DN using a block design (n = 8). The allocation concealment was carried out using the SNOSE method (sequentially numbered, opaque, sealed envelopes). UG-MSN was performed using an MSN (Shenlong Medical Apparatus, Suzhou, China; see Supplementary Figures 1(a) and 1(b) in the Supplementary Material available online at http://dx.doi.org/10.1155/2014/235817) as described earlier [9, 10] (Supplementary Figure 2(a)). The ultrasound system (SonoSite, Bothell, Washington, USA) comprised a high-frequency linear array transducer (10–5 MHz) covered by a sterilized medical condom as a disposable sterile medical ultrasound sheath (Shanghai Medical Dressing Factory, Shanghai, China; Supplementary Figures 1(c) and 1(d)).

With the patient in a lateral decubitus position, trigger points were identified by palpation by one author (YJZ) and marked with indelible ink. The skin was sterilized by povidone iodine. The transducer was applied transversely to the lateral aspect of the neck to obtain a transverse axial view. The seventh cervical vertebra (C7) was used as a reference and identified by the rudimentary anterior tubercle and a prominent posterior tubercle on the transverse process (Figures 2(a)–2(c)) [16]. By moving the transducer cranially, C6 was easily identified (Figure 3). Trigger points were identified by the following features: hyperechoic skin, adipose tissue of mixed echogenicity, and hyperechoic marbled appearance of muscle (Figure 3(c)) [18]. After confirming the trigger points, intradermal anesthesia with 1% lidocaine was performed using a 25-gauge, 1.5-inch needle and 2 mL syringe, and either UG-MSN release or UG-DN was performed on each point.

One author (YJZ) performed the treatment (either MSN release or DN under ultrasound guidance). For MSN release, when the pinpoint needle reached the trigger point, the MSN was moved up and down 2-3 times longitudinally around the vertebral lamina and the posterior tubercle of the transverse processes of C6 (Figure 3(c)). The miniscalpel did not extend deeper than the posterior tubercle of the transverse processes of the cervical vertebrae, thereby avoiding important structures between the posterior and anterior tubercles of the cervical vertebrae [19]. MSN release was performed once for each trigger point. For UG-DN, the needle was inserted in the trigger point, longitudinal to the transducer at the level of C6 ((Supplementary Figure 2(b)) and Figure 4). Needle placement was verified by asking the patient to contract the muscle and observing the needle under ultrasound. The needle was moved up and down 2-3 times. Again, the needle was inserted no deeper than the posterior tubercle of the transverse processes of the cervical vertebrae. DN was performed once for each trigger point.

2.3. Outcomes

The primary outcome was pain intensity. Secondary outcomes included pain disability and health-related quality of life. Pain intensity was measured using the 10-point VAS [18]. Pain disability was measured using the neck disability index (NDI), consisting of 10 questions with six possible responses, each of which was assigned a different number of points. The total NDI score can range from 0 to 50 points, with 50 indicating the worst condition [20, 21]. Health-related quality of life was measured using the SF-36 health status scale [22, 23].

The survey instruments were administered by a pain management specialist blinded to the treatment (even whether a patient was in the study or not). Outcomes were assessed before the treatment and at 3 and 6 months after the treatment.

2.4. Sample Size

Sample size was calculated based on a preliminary RCT involving 60 patients with chronic neck pain, 30 of whom were treated by UG-MSN release and 30 by UG-DN. None of the 60 subjects in this preliminary study was included in the current study. Sample size (n) was calculated according to the following equation for repeated measures at a significance level of 0.05 and power of 80%: n = 2 × (μ_α/2+μ_β)² × δ² × (1 − ρ)/(m × s² × (β_1A−β_1B)²)  (μ_α/2 = 1.96, μ_β = 0.842) [24]. Based on the results of the preliminary study, the variance of repeated measurements (δ²) was 3.08; the symmetric correlation coefficient (ρ) was 0.38; the number of repetitions (m) was 3; s² = ∑(t_j−t)²/m = 8.25, where t_j is the time when repeated measures are performed and t is the average time of repeated measures; and β_1A − β_1B = 0.137, where β_1A and β_1B are the slopes (change in measurement over time) for the UG-MSN and UG-DN groups, respectively. This equation indicated the need for 64 participants per arm, so we recruited 80 patients for each arm to take into account a 20% dropout rate.

2.5. Randomization

Subjects were randomly allocated into UG-MSN or UG-DN group based on a computer-generated allocation sequence using a block design (n = 8). Allocation concealment was carried out using the SNOSE method (sequentially numbered, opaque, sealed envelopes). The next envelope in the sequence was opened after the participant had given informed consent.

2.6. Blinding

Patients were blinded to their treatment allocation and did not see the instruments during the procedure. The pain management specialist who conducted assessment was also blinded to the treatment condition. The same physician (YJZ) performed UG-MSN and UG-DN procedures on all participants. Data were analyzed by an independent statistician.

2.7. Statistical Analysis

All data were analyzed using SPSS 13.0 (IBM, Chicago, USA). Data for continuous variables showing a normal distribution were reported as means and standard deviations (SD); otherwise, data were reported as median. Intergroup differences were assessed for statistical significance using independent Student's t-test for normally distributed data and the Mann-Whitney test for nonnormally distributed data. Intergroup differences in categorical variables were assessed for significance using the χ² test or Fisher's exact test. Analysis of covariance was also used to assess differences between the two groups based on F-statistics. The baseline served as a covariate. The significance level for all tests was set at 0.05.

3.1. Participant Flow

From January 2009 to February 2010, 250 participants were approached, of which 81 were excluded, leaving 169 who were randomized into UG-MSN or UG-DN group (Figure 1). Each group received the corresponding treatment once a week for three weeks. Of the 169 patients, 14 (8.3%) dropped out, and the dropout rate was similar for the UG-MSN release and UG-DN groups (6.8% versus 9.9%, P = 0.5801, χ² test). In the UG-MSN group, 4 patients were lost to follow-up by 3 months posttreatment and 6 were lost by 6 months. In the UG-DN group, 4 patients were lost by 3 months and 8 were lost by 6 months.

Scores on the VAS, NDI, SF-36 PCS, and SF-36 MCS were measured immediately prior to the start of treatment and again at 3 and 6 months posttreatment. VAS scores at baseline were similar for the patients lost to follow-up from either group at 3 months and 6 months (P > 0.05, Mann-Whitney nonparametric tests). This suggests that losses to follow-up did not significantly affect the outcomes measured for the patients who completed the trial.

3.2. Baseline Characteristics

Baseline demographic data, disease duration, previous treatments, and scores on the VAS, NDI, SF-36 PCS, and SF-36 MCS are shown in Table 1. None of these parameters differed significantly between the two treatment groups.

3.3. Outcome Measures

The final analysis included data for 82 of 88 patients (93.2%) in the UG-MSN release group and for 73 of 81 patients (90.1%) in the UG-DN group. Analyses of covariance were performed in which the score on the VAS, NDI, SF-36 PCS, or SF-36 MCS at 3 and 6 months served as the response variable (outcome) and treatment served as the explanatory variable; results were adjusted for baseline differences in the response variable.

At 3 months posttreatment, the adjusted mean VAS was 0.9 points higher in the UG-DN group than in the UG-MSN release group (β = 0.9, SD = 0.2, P < 0.0001); at 6 months, this difference had grown to 2.0 points (β = 2.0, SD = 0.2, P < 0.0001; Table 2). Group-level analysis showed that mean VAS decreased by 51.5% from baseline to 3 months in the UG-MSN release group, compared to 40.8% in the UG-DN group. Mean VAS decreased by 44.1% from baseline to 6 months in the UG-MSN release group, compared to 18.3% in the UG-DN group. Patient-level analysis showed that 50 of 84 patients in the UG-MSN release group showed a >50% reduction in VAS from baseline to 3 months, compared to 38 of 84 patients in the UG-DN group. The corresponding proportions at 6 months were 35 of 82 patients in the UG-MSN release group, compared to 15 of 82 patients in the UG-DN group.

At 3 months posttreatment, the adjusted average NDI was 2.4 points higher in the UG-DN group than in the UG-MSN release group (β = 2.4, SD = 0.7, P < 0.0001); at 6 months, this difference had grown to 5.3 points (β = 5.3, SD = 0.7, P < 0.0001; Table 2). Group-level analysis showed that mean NDI decreased by 64.3% from baseline to 3 months in the UG-MSN release group, compared to 45% in the UG-DN group. Mean NDI decreased by 60.3% from baseline to 6 months in the UG-MSN release group, compared to 23.8% in the UG-DN group. Patient-level analysis showed that 55 of 84 patients in the UG-MSN release group showed a >50% reduction from baseline to 3 months, compared to 40 of 84 patients in the UG-DN group. The corresponding proportions at 6 months were 50 of 82 patients in the UG-MSN release group, compared to 17 of 82 patients in the UG-DN group.

At 3 months posttreatment, the adjusted mean SF-36 PCS was 5.5 points lower in the UG-DN group than in the UG-MSN release group (β = 5.5, SD = 2.2, P = 0.013); at 6 months, this difference had grown to 7.5 points (β = 7.5, SD = 3.3, P = 0.024; Table 2). Group-level analysis showed that mean SF-36 PCS improved by 19.1% from baseline to 3 months in the UG-MSN release group, compared to 1.1% in the UG-DN group. Mean SF-36 PCS improved by 33.4% from baseline to 6 months in the UG-MSN release group, compared to 9.9% in the UG-DN group. However, the two treatment groups showed similar SF-36 MCS scores at 6 months.

3.4. Treatment Adherence

Treatment adherence rates were similar between the two treatment groups: 82 of 88 subjects (93.2%) in the UG-MSN release group completed the study protocol, compared to 73 of 81 (90.1%) in the UG-DN group (P = 0.5801, χ² test).

3.5. Adverse Events

Six participants in the UG-MSN release group (7.3%) and 7 in the UG-DN group (9.6%) reported mild reactions during treatment, mainly slight pain and somatic reactions such as sweating. However, all these participants agreed to continue the treatment. No serious adverse complications, such as spinal injury or nerve injury, were recorded.

• 1.Hogg-Johnson S., van der Velde G., Carroll L. J., Holm L. W., Cassidy J. D., Guzman J., Côté P., Haldeman S., Ammendolia C., Carragee E., Hurwitz E., Nordin M., Peloso P. The burden and determinants of neck pain in the general population: Results of the Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders. Spine. 2008;33(4):S39–S51. doi: 10.1097/BRS.0b013e31816454c8. [DOI] [PubMed] [Google Scholar]
• 2.Borghouts J. A. J., Koes B. W., Vondeling H., Bouter L. M. Cost-of-illness of neck pain in The Netherlands in 1996. Pain. 1999;80(3):629–636. doi: 10.1016/S0304-3959(98)00268-1. [DOI] [PubMed] [Google Scholar]
• 3.Alvarez D. J., Rockwell P. G. Trigger points: diagnosis and management. American Family Physician. 2002;65(4):653–660. [PubMed] [Google Scholar]
• 4.Furlan A. D., van Tulder M. W., Cherkin D. C., Tsukayama H., Lao L., Koes B. W., Berman B. M. Acupuncture and dry-needling for low back pain. Cochrane Database of Systematic Reviews. 2005;25(1) doi: 10.1002/14651858.CD001351.pub2.CD001351 [DOI] [PubMed] [Google Scholar]
• 5.Irnich D., Behrens N., Gleditsch J. M., Stör W., Schreiber M. A., Schöps P., Vickers A. J., Beyer A. Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized, double-blind, sham-controlled crossover trial. Pain. 2002;99(1-2):83–89. doi: 10.1016/S0304-3959(02)00062-3. [DOI] [PubMed] [Google Scholar]
• 6.Irnich D., Behrens N., Molzen H., König A., Gleditsch J., Krauss M., Natalis M., Senn E., Beyer A., Schöps P. Randomised trial of acupuncture compared with conventional massage and “sham” laser acupuncture for treatment of chronic neck pain. British Medical Journal. 2001;322(7302):1574–1578. doi: 10.1136/bmj.322.7302.1574. [DOI] [PMC free article] [PubMed] [Google Scholar]
• 7.Hsieh Y.-L., Kao M.-J., Kuan T.-S., Chen S.-M., Chen J.-T., Hong C.-Z. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. American Journal of Physical Medicine and Rehabilitation. 2007;86(5):397–403. doi: 10.1097/PHM.0b013e31804a554d. [DOI] [PubMed] [Google Scholar]
• 8.Tough E. A., White A. R., Cummings T. M., Richards S. H., Campbell J. L. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. European Journal of Pain. 2009;13(1):3–10. doi: 10.1016/j.ejpain.2008.02.006. [DOI] [PubMed] [Google Scholar]
• 9.Ma C., Wu S., Li G., Xiao X., Mai M., Yan T. Comparison of miniscalpel-needle release, acupuncture needling, and stretching exercise to trigger point in myofascial pain syndrome. The Clinical Journal of Pain. 2010;26(3):251–257. doi: 10.1097/AJP.0b013e3181b8cdc8. [DOI] [PubMed] [Google Scholar]
• 10.Wang C., Xiong Z., Deng C., Yu W., Ma W. Miniscalpel-needle versus trigger-point injection for cervical myofascial pain syndrome: a randomized comparative trial. Journal of Alternative and Complementary Medicine. 2007;13(1):14–16. doi: 10.1089/acm.2006.6128. [DOI] [PubMed] [Google Scholar]
• 11.Chao M., Wu S., Yan T. The effect of miniscalpel-needle versus steroid injection for trigger thumb release. Journal of Hand Surgery: European Volume. 2009;34(4):522–525. doi: 10.1177/1753193409100961. [DOI] [PubMed] [Google Scholar]
• 12.Ding Y., Duan Y., Li Y., Zhang L. The analysis of complications caused by the treatment of tenosynovitis by miniscalpel-needle. Journal of Hebei North University (Medical Edition) 2007;24:67–68. [Google Scholar]
• 13.Zhang Y., Guo C. Discussion on security of acupotomology. Chinese Archives of Traditional Chinese Medicine. 2011;29:2214–2215. [Google Scholar]
• 14.Galiano K., Obwegeser A. A., Bodner G., Schatzer R., Schocke M., Gruber H. Ultrasound is not the only technique to visualize third occipital nerve blockade. Anesthesiology. 2006;105(4):858. doi: 10.1097/00000542-200610000-00043. [DOI] [PubMed] [Google Scholar]
• 15.Galiano K., Obwegeser A. A., Walch C., Schatzer R., Ploner F., Gruber H. Ultrasound-guided versus computed tomography-controlled facet joint injections in the lumbar spine: a prospective randomized clinical trial. Regional Anesthesia and Pain Medicine. 2007;32(4):317–322. doi: 10.1016/j.rapm.2007.03.010. [DOI] [PubMed] [Google Scholar]
• 16.Narouze S. N., Vydyanathan A., Kapural L., Sessler D. I., Mekhail N. Ultrasound-guided cervical selective nerve root block: a fluoroscopy-controlled feasibility study. Regional Anesthesia and Pain Medicine. 2009;34(4):343–348. doi: 10.1097/AAP.0b013e3181ac7e5c. [DOI] [PubMed] [Google Scholar]
• 17.Lepage L., Altman D. G., Schulz K. F., Moher D., Egger M., Davidoff F., Elbourne D., Gøtzsche P. C., Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine. 2001;134(8):663–694. doi: 10.7326/0003-4819-134-8-200104170-00012. [DOI] [PubMed] [Google Scholar]
• 18.Huskisson E. C. Measurement of pain. The Lancet. 1974;2(7889):1127–1131. doi: 10.1016/s0140-6736(74)90884-8. [DOI] [PubMed] [Google Scholar]
• 19.Narouze S. Sonoanatomy of the cervical spinal nerve roots: implications for brachial plexus block. Regional Anesthesia and Pain Medicine. 2009;34(6):616. doi: 10.1097/AAP.0b013e3181b4d0aa. [DOI] [PubMed] [Google Scholar]
• 20.Vernon H., Mior S. The neck disability index: a study of reliability and validity. Journal of Manipulative and Physiological Therapeutics. 1991;14:409–415. [PubMed] [Google Scholar]
• 21.Wu S., Ma C., Mai M., Li G. Translation and validation study of Chinese versions of the neck disability index and the neck pain and disability scale. Spine. 2010;35(16):1575–1579. doi: 10.1097/BRS.0b013e3181c6ea1b. [DOI] [PubMed] [Google Scholar]
• 22.Ware J. E., Jr., Sherbourne C. D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care. 1992;30(6):473–483. doi: 10.1097/00005650-199206000-00002. [DOI] [PubMed] [Google Scholar]
• 23.Li L., Wang H. M., Shen Y. Chinese SF-36 Health Survey: translation, cultural adaptation, validation, and normalisation. Journal of Epidemiology and Community Health. 2003;57(4):259–263. doi: 10.1136/jech.57.4.259. [DOI] [PMC free article] [PubMed] [Google Scholar]
• 24.Ma B., Li K. Medical Statistics. Beijing, China: People's Medical Publishing House; 2008. [Google Scholar]
• 25.Ghia J. N., Mao W., Toomey T. C., Gregg J. M. Acupuncture and chronic pain mechanisms. Pain. 1976;2(3):285–299. doi: 10.1016/0304-3959(76)90006-3. [DOI] [PubMed] [Google Scholar]
• 26.Scott N. A., Guo B., Barton P. M., Gerwin R. D. Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. Pain Medicine. 2009;10(1):54–69. doi: 10.1111/j.1526-4637.2008.00526.x. [DOI] [PubMed] [Google Scholar]
• 27.Kalawokalani D. Malpractice claims for non-operative pain management: a growing pain for anesthesiologists? ASA Professional Information. 1999;63(6):16–18. [Google Scholar]
• 28.Botwin K. P., Sharma K., Saliba R., Patel B. C. Ultrasound-guided trigger point injections in the cervicothoracic musculature: a new and unreported technique. Pain Physician. 2008;11(6):885–889. [PubMed] [Google Scholar]
• 29.Dincer F., Linde K. Sham interventions in randomized clinical trials of acupuncture—a review. Complementary Therapies in Medicine. 2003;11(4):235–242. doi: 10.1016/S0965-2299(03)00124-9. [DOI] [PubMed] [Google Scholar]

Supplementary Materials