Effectiveness of Dry Needling in Chronic Neck Pain.

NCT03844802 | Completed DMC

• 1 other identifier: Dry Needling
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Neck Pain

Keywords

neck pain; randomized control trial; trigger points; dry needling; physical therapy; placebo; therapeutic exercise

Outcome Measures

Primary Outcomes (4)

• Change from baseline Self-reported neck pain intensity in neutral head position at 6 months.

  Current pain intensity in neutral head position, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.

  From Baseline to after treatment,with a 3-month and a 6- month follow up

• Change from baseline self-reported neck pain intensity associated to the most painful cervical rotation at 6 months

  Current pain intensity during the most painful passive cervical rotation, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

• Change from baseline mean self-reported neck pain intensity during the last week at 6 months.

  The subject is asked about the mean pain intensity during the previous week, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.

  From Baseline to after treatment,with a 3-month and a 6- month follow up.

• Change from baseline worst self-reported neck pain intensity in the last 24 hours at 6 months.

  The subject is asked about the highest neck pain intensity in the last 24 hours, as assessed with a numeric pain rating scale (NPRS).The subject is asked about theThe Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

Secondary Outcomes (5)

• Change from baseline self-reported neck related disability at 6 months.

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

• Change from baseline pressure pain sensitivity in neck shoulder muscles and brachial plexus nerve trunks at 6 months

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

• Global Rating of Change.

  After treatment, with a 3-month and a 6- month follow up.

• Change from baseline muscle viscoelastic properties (muscle tone and stiffness) at 6 months

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

• Change from baseline left-Right discrimination ability at 6 months.

  From Baseline to after treatment, with a 3-month and a 6- month follow up.

Study Arms (4)

Local dry needling and exercise

EXPERIMENTAL

The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 dry needling session a week during 3 consecutive weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months.

Other: Local Dry needling and exercise

Distal dry needling and exercise

ACTIVE COMPARATOR

The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in distant area from the location of active or latent myofascial trigger points of different neck-shoulder muscles. Therefore, dry needling will be applied in the same muscle but at a remote site from the locus of the myofascial trigger point, and, therefore, without evoking local twitch responses. Patients will receive 1 dry needling session a week during 3 weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months.

Other: Distal Dry needling and exercise

Sham/placebo dry needling and exercise

ACTIVE COMPARATOR

The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 "placebo dry needling" session a week during 3 weeks (3 sessions in total). Therefore, participants in this group will receive simulated dry needling (with sham placebo needles, that will not actually penetrate the skin) in those neck muscles with active or latent myofascial trigger points. As formerly stated, the placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.They will also undergo the neck exercise program at home during these three weeks, and for the next three months.

Other: Sham dry needling and exercise

Neck Exercise

ACTIVE COMPARATOR

The intervention protocol will consist only a home-based neck and shoulder exercise program. Participants in this group will be also assessed for the presence of active or latent myofascial trigger points in the neck-shoulder muscles. As in the other groups, they will be advised to carry out the exercise protocol for three weeks and the following three months.

Other: Exercise

Interventions

Local Dry needling and exercise OTHER

Deep dry needling will be applied bilaterally in the locus of active or latent myofascial trigger points of several neck shoulder muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius). The presence of active or latent myofascial trigger points will be assessed according to the diagnostic procedures described by Travell and Simons. The dry needling intervention technique will be the fast in-fast out Hong technique, with a minimum of 3 to 6 local twitch responses to be elicited. Patients will perform a home based therapeutic neck exercises program.

Local dry needling and exercise

Distal Dry needling and exercise OTHER

Patients in this group will undergo deep dry needling at a remote spot from the locus of the myofascial trigger point. As a result no local twitch response should be elicited. As in the previous group, dry needling will be carried out in the same assessed muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for these participants will be to insert the needle in a location in the same muscle, but far away (at least 1 to 1.5 cm) from the location of the myofascial trigger point. Likewise, the needle will be inserted without the intention to evoke local twitch responses. Therefore, the entry and exit of the needle will be performed in a slower fashion. Patients will perform a home based therapeutic neck exercises program.

Distal dry needling and exercise

Sham dry needling and exercise OTHER

Patients in this group will undergo sham-placebo dry needling. For that purpose, placebo dry needling will be carried out in the same muscles previously described (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points. The intervention technique will be carried out in the locus of the trigger point but using placebo needles. For this placebo group, a simulation needle procedure using a Dong Bang placebo needle, similar to the Streitberger needle, will be used. The placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle. Patients will perform a home based therapeutic neck exercises program.

Sham/placebo dry needling and exercise

Exercise OTHER

Patients will perform a home based therapeutic neck exercises program.

Neck Exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of non-specific mechanical neck pain.
• Pain lasting for more than 3 months of duration.
• Self-reported pain higher than 3 in the Numeric Pain Rating Scale.
• Self-reported neck disability higher than 5 in the Neck Disability Index.

You may not qualify if:

• Absence of pain during passive neck rotation.
• Higher pain intensity in neutral position than during passive neck rotation.
• Absence of ipsilateral pain during passive neck rotation.
• Previous history of surgery of the cervical spine or upper extremity.
• Previous history of whiplash, diagnosis of fibromyalgia, or any neurological, inflammatory or rheumatological disease.
• Presence of two or more positive signs indicative of neural compression (sensitivity disorders, myotomic weakness in the upper extremities, or alteration in deep tendon reflexes).
• Radiological signs of root compression or spinal stenosis.
• Having received physical therapy treatment in the month prior to the start of the study.
• Analgesic and / or anti-inflammatory treatment in the last 72 h.
• Diagnosis of psychiatric disorders with ongoing medical treatment.
• Pregnancy or breastfeeding.
• Pending litigation in progress.
• Any contraindication to the use of dry needling.

Sponsors & Collaborators

• University of Seville: lead
• Junta de Andalucia: collaborator

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alberto M Heredia-Rizo, PhD

  Physiotherapy Department, University of Sevilla, Spain

  STUDY DIRECTOR

• Fernando Piña-pozo, PT

  Physiotherapy Department, University of Sevilla, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The therapist in charge of the evaluation will remain unaware of participants' allocation group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: March 25, 2019
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)