Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain
NCT ID: NCT06453408
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2024-06-25
2024-10-31
Brief Summary
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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.
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Detailed Description
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Objective: The main objective of this study is to validate a placebo dry needling protocol. The secondary objective is to examine whether the patient's previous experience with dry needling influences their ability to discern between having received a real or placebo needling and how this impacts on the outcomes of the intervention.
Material and method: 70 participants aged 18-65 years with non-specific neck pain who meet the inclusion criteria will be recruited. They will be assigned to one of two groups, those who have previously received dry needling and those who have not. Thereafter, members of each group will be randomised and assigned to either the real dry needling or placebo group. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo, sin experiencia
Group of patients with no previous experience in dry needling, will be given placebo dry needling
Punción seca con aguja retráctil
The placebo dry needling protocol will be performed in the same position, with identical antiseptic measures and the same number of simulated incisions as the real dry needling protocol, using DONGBANG AcuPrime® 0.30 x 30mm blunt-tipped placebo needles with a retractable handle. These needles simulate the sensation of needle contact without penetrating the skin. The therapist will hold the needle and guide tube, pressing the tube against the skin and simulating needle manipulation. Changes in pressure direction will mimic the real technique. The protocol will end with compression using an alcohol swab and an upper trapezius stretch.
Participants in both groups will receive the same information about the sensations of the dry needling procedure. At the beginning, they will be informed that they may or may not feel the needle insertion. They will also be told that the physiotherapist will manually manipulate the needle multiple times during the procedure.
Placebo, con experiencia
Group of patients with previous experience in dry needling, will be given placebo dry needling
Punción seca con aguja retráctil
The placebo dry needling protocol will be performed in the same position, with identical antiseptic measures and the same number of simulated incisions as the real dry needling protocol, using DONGBANG AcuPrime® 0.30 x 30mm blunt-tipped placebo needles with a retractable handle. These needles simulate the sensation of needle contact without penetrating the skin. The therapist will hold the needle and guide tube, pressing the tube against the skin and simulating needle manipulation. Changes in pressure direction will mimic the real technique. The protocol will end with compression using an alcohol swab and an upper trapezius stretch.
Participants in both groups will receive the same information about the sensations of the dry needling procedure. At the beginning, they will be informed that they may or may not feel the needle insertion. They will also be told that the physiotherapist will manually manipulate the needle multiple times during the procedure.
Real, sin experiencia
Group of patients with no previous experience in dry needling, real dry needling will be applied
Punción seca con aguja normativa.
To perform the actual SP, patients shall be asked to lie prone with arms close to the body. The dry needling shall be performed with a 0,30 × 30 mm DN needle (APS Regular Agupunt) with a guide tube. The therapist shall first clean the area with alcohol. The trapezius muscle is then firmly grasped with a clamp between the thumb and index finger, so that the needle is directed deep into the index finger until the tip of the needle is felt to be approaching (33). This procedure involves an approximate insertion of the needle to a depth of 30 mm and ensures the intramuscular penetration necessary for dry needling. Puncture of the PGM shall be performed using the Hong technique (34), performing up to 12 inlets and outlets, at a frequency of 1 Hz. When the needle is withdrawn, the area is firmly compressed with cotton wool for 60 seconds. Finally, the upper trapezius muscle is stretched, following the technique originally described by Simons (35).
Real, con experiencia
Group of patients with previous experience in dry needling, real dry needling will be applied.
Punción seca con aguja normativa.
To perform the actual SP, patients shall be asked to lie prone with arms close to the body. The dry needling shall be performed with a 0,30 × 30 mm DN needle (APS Regular Agupunt) with a guide tube. The therapist shall first clean the area with alcohol. The trapezius muscle is then firmly grasped with a clamp between the thumb and index finger, so that the needle is directed deep into the index finger until the tip of the needle is felt to be approaching (33). This procedure involves an approximate insertion of the needle to a depth of 30 mm and ensures the intramuscular penetration necessary for dry needling. Puncture of the PGM shall be performed using the Hong technique (34), performing up to 12 inlets and outlets, at a frequency of 1 Hz. When the needle is withdrawn, the area is firmly compressed with cotton wool for 60 seconds. Finally, the upper trapezius muscle is stretched, following the technique originally described by Simons (35).
Interventions
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Punción seca con aguja retráctil
The placebo dry needling protocol will be performed in the same position, with identical antiseptic measures and the same number of simulated incisions as the real dry needling protocol, using DONGBANG AcuPrime® 0.30 x 30mm blunt-tipped placebo needles with a retractable handle. These needles simulate the sensation of needle contact without penetrating the skin. The therapist will hold the needle and guide tube, pressing the tube against the skin and simulating needle manipulation. Changes in pressure direction will mimic the real technique. The protocol will end with compression using an alcohol swab and an upper trapezius stretch.
Participants in both groups will receive the same information about the sensations of the dry needling procedure. At the beginning, they will be informed that they may or may not feel the needle insertion. They will also be told that the physiotherapist will manually manipulate the needle multiple times during the procedure.
Punción seca con aguja normativa.
To perform the actual SP, patients shall be asked to lie prone with arms close to the body. The dry needling shall be performed with a 0,30 × 30 mm DN needle (APS Regular Agupunt) with a guide tube. The therapist shall first clean the area with alcohol. The trapezius muscle is then firmly grasped with a clamp between the thumb and index finger, so that the needle is directed deep into the index finger until the tip of the needle is felt to be approaching (33). This procedure involves an approximate insertion of the needle to a depth of 30 mm and ensures the intramuscular penetration necessary for dry needling. Puncture of the PGM shall be performed using the Hong technique (34), performing up to 12 inlets and outlets, at a frequency of 1 Hz. When the needle is withdrawn, the area is firmly compressed with cotton wool for 60 seconds. Finally, the upper trapezius muscle is stretched, following the technique originally described by Simons (35).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Alcala
OTHER
Responsible Party
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Leire Vázquez Casar
Leire Vázquez Casar
Principal Investigators
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Leire Vazquez-Casar
Role: PRINCIPAL_INVESTIGATOR
University of Alcala
Central Contacts
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References
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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.
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.
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.
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.
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.
Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
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.
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.
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.
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.
Other Identifiers
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PS-Leire
Identifier Type: -
Identifier Source: org_study_id
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