Neck Pain Clinical Trial
Official title:
Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain: a Randomised Controlled Clinical Trial
This study aims to validate a placebo dry needling protocol for patients with non-specific neck pain and investigate whether prior experience with dry needling affects their ability to distinguish between real and placebo treatments, and how this impacts outcomes. Seventy participants aged 18-65 will be recruited and divided into two groups based on their previous dry needling experience, then randomized into real or placebo needling groups. Assessment will be carried out before treatment, immediately after the procedure and one week later. Pain intensity, pain threshold to pressure, cervical range of motion, level of disability and presence of central sensitisation will also be measured.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | October 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Non-specific neck pain, unilateral or bilateral. - Neck pain lasting = 3 months. - Presence of active myofascial trigger point (MTrP) in the upper trapezius muscle, left, right or bilateral, in relation to the patient's neck pain. Exclusion Criteria: - Fear or phobia of needles - Skin lesions, infection or inflammation in the area to be pricked - Specific alterations of the cervical region in the medical history - Coagulation disorders - Surgical intervention of the cervical or anterior shoulder region - Undergoing pharmacological treatment with analgesics, anti-inflammatory drugs or anticoagulants in the week prior to the study. - Having received physiotherapy treatment in the neck region in the 6 months prior to the intervention. - Infiltration of corticosteroids or local anaesthetics up to one year prior to the study. - Cognitive deficits in the medical history. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Alcala |
Andrade Ortega JA, Delgado Martinez AD, Almecija Ruiz R. [Validation of a Spanish version of the Neck Disability Index]. Med Clin (Barc). 2008 Feb 2;130(3):85-9. doi: 10.1157/13115352. Spanish. — View Citation
Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78. — View Citation
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016. — View Citation
Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118. — View Citation
Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. doi: 10.1089/acm.2006.12.303. — View Citation
Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93. — View Citation
Cuesta-Vargas AI, Roldan-Jimenez C, Neblett R, Gatchel RJ. Cross-cultural adaptation and validity of the Spanish central sensitization inventory. Springerplus. 2016 Oct 21;5(1):1837. doi: 10.1186/s40064-016-3515-4. eCollection 2016. — View Citation
Hafliethadottir SH, Juhl CB, Nielsen SM, Henriksen M, Harris IA, Bliddal H, Christensen R. Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects. Trials. 2021 Jul 26;22(1):493. doi: 10.1186/s13063-021-05454-8. — View Citation
Pariente J, White P, Frackowiak RS, Lewith G. Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage. 2005 May 1;25(4):1161-7. doi: 10.1016/j.neuroimage.2005.01.016. — View Citation
Rodriguez-Huguet M, Vinolo-Gil MJ, Gongora-Rodriguez J. Dry Needling in Physical Therapy Treatment of Chronic Neck Pain: Systematic Review. J Clin Med. 2022 Apr 23;11(9):2370. doi: 10.3390/jcm11092370. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful identification rate of group assignment | A Questionnaire of its own, designed to record participants' perceptions of the perceived intervention, will be used. Participants will be asked to select which group they believe they belong to by choosing one of five possible responses:
I strongly believe I was assigned to the treatment group. I believe to some extent that I was assigned to the treatment group. I believe to some extent that I was assigned to the control group. I strongly believe that I was assigned to the control group. I am not sure |
Immediately after the intervention and one week later, in order to see if any participants change their response. | |
Secondary | Pain intensity | Visual Analogic Scale | Before and immediately after the intervention, and a new assessment will be carried out one week later. | |
Secondary | Neck disability | neck disability index | Before and one week after the intervention. | |
Secondary | Cervical Range of Motion | Grades | Before intervention, immediately after intervention and after one week. | |
Secondary | central sensitisation | The Central Sensitisation Inventory (CSI) | Before the intervention and one week after | |
Secondary | Pressure pain threshold | kg/sec | Before the intervention, immediately after the intervention and one week afterwards |
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