Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-09 @ 3:27 AM
Study NCT ID:
NCT03844802
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Dry Needling in Chronic Neck Pain.
Sponsor:
University of Seville
Organization:
Study Overview
Official Title:
Effectiveness of Real or Placebo Dry Needling Combined With Therapeutic Exercise in Adults With Chronic Neck Pain
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives: To investigate the effect of combining real or placebo dry needling with therapeutic exercise in self-reported pain, pressure pain sensitivity, neck disability, global rating of change (GROC) scale, muscle viscoelastic properties (muscle tone and stiffness) and left/right discrimination ability in adults with chronic non-specific neck pain.
Design: Quantitative, experimental, longitudinal, prospective, and single blinded study.
Subjects: Participants aged between 18 and 60 years, and with non specific neck pain of at least 3 months of evolution.
Methods: Participants will be randomly allocated in four groups: a) isolated use of a home based therapeutic exercise (TE) program (TE Group); b) combination of the exercise program and the use of deep dry needling (DN) in neck shoulder muscles with active or latent myofascial trigger points (MTrPs) in order to elicit local twitch responses (LTR) (TE + local DN Group); c) therapeutic exercise combined with DN applied distally from the muscle areas with MTrPs and, therefore, without, eliciting LTRs (TE + distal DN Group); and d) therapeutic exercise program combined with placebo DN (TE + placebo DN Group).
Design: Quantitative, experimental, longitudinal, prospective, and single blinded study.
Subjects: Participants aged between 18 and 60 years, and with non specific neck pain of at least 3 months of evolution.
Methods: Participants will be randomly allocated in four groups: a) isolated use of a home based therapeutic exercise (TE) program (TE Group); b) combination of the exercise program and the use of deep dry needling (DN) in neck shoulder muscles with active or latent myofascial trigger points (MTrPs) in order to elicit local twitch responses (LTR) (TE + local DN Group); c) therapeutic exercise combined with DN applied distally from the muscle areas with MTrPs and, therefore, without, eliciting LTRs (TE + distal DN Group); and d) therapeutic exercise program combined with placebo DN (TE + placebo DN Group).
Detailed Description:
All groups will be instructed by a physiotherapist in the performance of protocol of neck-shoulder exercises. This program will be carried out at home for at least three days a week during three months. The exercise protocol includes active mobilization, stretching and strengthening (concentric/eccentric, isotonic, and isometric) exercises. All participants will be given a booklet with a detailed description of every single exercise.
Those participants included in any of the DN groups will undergo 3 sessions of treatment (1 session per week during 3 consecutive weeks). In each session, the physiotherapist in charge of the intervention will assess the presence of active or latent MTrPs in severa neck shoulder muscles. The selected muscles have been previously described as having a higher prevalence of MTrPs in adults with chronic neck pain: a) scalene muscles; b) levator scapulae; c) splenius cervicis; d) cervical multifidus; and e) upper trapezius trapezius. The location of the trigger points will be carried out following the recommendations and guidelines described in the literature.
Those in the TE + local DN group will receive deep DN, using a fast-in fast-out technique, as described by Hong. The needle, once inserted in the muscle with a 10 to 20 mm depth, will be mobilized in a quick ascending and descending motion, in order to evoke the so-called LTRs. A minimum of 3 to 6 LTRs will be elicited in each muscle.
For patients in the TE + distal DN group, the deep DN intervention will be carried out in those muscles with MTrPs, but at a remote location from the MTrP area. The same evaluation and intervention protocol previously described for the TE + local DN group will be carried out. The main difference is that, in this group, DN will not elicit LTRs. Instead, DN will be applied at a minimum distance of 1-1.5 cm from the MTrP locus.
Finally, in the TE + placebo DN group, the therapeutic exercise program will be combined with DN using using a Dong Bang placebo needle, similar to the Streitberger placebo needle. These needles are designed with a retractable system. Therefore, these placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.
Those participants included in any of the DN groups will undergo 3 sessions of treatment (1 session per week during 3 consecutive weeks). In each session, the physiotherapist in charge of the intervention will assess the presence of active or latent MTrPs in severa neck shoulder muscles. The selected muscles have been previously described as having a higher prevalence of MTrPs in adults with chronic neck pain: a) scalene muscles; b) levator scapulae; c) splenius cervicis; d) cervical multifidus; and e) upper trapezius trapezius. The location of the trigger points will be carried out following the recommendations and guidelines described in the literature.
Those in the TE + local DN group will receive deep DN, using a fast-in fast-out technique, as described by Hong. The needle, once inserted in the muscle with a 10 to 20 mm depth, will be mobilized in a quick ascending and descending motion, in order to evoke the so-called LTRs. A minimum of 3 to 6 LTRs will be elicited in each muscle.
For patients in the TE + distal DN group, the deep DN intervention will be carried out in those muscles with MTrPs, but at a remote location from the MTrP area. The same evaluation and intervention protocol previously described for the TE + local DN group will be carried out. The main difference is that, in this group, DN will not elicit LTRs. Instead, DN will be applied at a minimum distance of 1-1.5 cm from the MTrP locus.
Finally, in the TE + placebo DN group, the therapeutic exercise program will be combined with DN using using a Dong Bang placebo needle, similar to the Streitberger placebo needle. These needles are designed with a retractable system. Therefore, these placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: