Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04060004
Other study ID # 1.0 14/12/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2019
Est. completion date May 27, 2021

Study information

Verified date July 2023
Source University of Valladolid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena. To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points. This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.


Description:

The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group. In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups. For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group. The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 27, 2021
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients with myofascial neck pain - Presence of at least one active myofascial trigger point on the superficial neck musculature - Neck pain of at least 3 months - Age 18-70 - Pain intensity between 20 and 100 mm in the Analog Visual Scale - Neck disability index (NDI) greater than or equal to 15 points - Spanish speakers - Patients who do not present contraindications for the use of dry needling (anticoagulants, nickel allergy or belenophobia) - Patients who have not received physiotherapy or pharmacological treatment for neck pain for the last three months Exclusion Criteria: - History of cervical trauma - Cervical spine surgery - Vertebral fracture - Cervical pain associated with whiplash - Red flags (tumor, metabolic disorders or rheumatoid arthritis) - Inflammatory lesion in the neck region - Pregnancy - Fibromyalgia diagnosis - Neck pain associated with radiculopathy - Patients pending legal litigation - Psychiatric pathology diagnosis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dry needling
Dry needling is a technique used by physiotherapists.
Sham dry needling
Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.
Electrotherapy + therapeutic exercise
Standard care of neck pain.

Locations

Country Name City State
Spain Facultad de Fisioterapia, Universidad de Valladolid Soria

Sponsors (1)

Lead Sponsor Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck pain The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline. Baseline.
Primary Neck pain The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days). Through study completion, an average of 11 days.
Primary Cervical disability The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline. Baseline.
Primary Cervical disability The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Primary Motor control The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline. Baseline.
Primary Motor control The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Secondary Neck range of motion The investigators measure the neck range of motion with an inclinometer at baseline. Baseline.
Secondary Neck range of motion The investigators measure the neck range of motion with an inclinometer at the end of the intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Secondary Pressure pain threshold The investigators measure the pressure pain threshold with a digital algometer at baseline. Baseline.
Secondary Pressure pain threshold The investigators measure the pressure pain threshold with a digital algometer at the end of the intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Secondary Kinesiophobia The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline. Baseline.
Secondary Kinesiophobia The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at the end of the intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Secondary Pain catastrophism The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline. Baseline.
Secondary Pain catastrophism The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at the end of intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
Secondary Anxiety and depression The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline. Baseline.
Secondary Anxiety and depression The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at the end of intervention (through study completion, an average 11 days). Through study completion, an average 11 days.
See also
  Status Clinical Trial Phase
Completed NCT05293847 - Postural Based Telerehabilitation in Mechanic Neck Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Active, not recruiting NCT05870371 - The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain N/A
Completed NCT06049316 - Scapular Stabilization vs Functional Exercises on Chronic Neck Pain N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Completed NCT02882061 - Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain N/A
Completed NCT02731014 - Dry Needling for Patients With Neck Pain N/A
Completed NCT02904668 - Self-management Program in Chronic Neck Pain N/A
Completed NCT03147508 - Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
Completed NCT02638987 - EMG Activity Before, During and After Dry Needling N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02225873 - The Effectiveness of Exercises Protocol in Management of Neck Pain N/A
Completed NCT02235207 - Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain N/A
Completed NCT02245425 - Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain N/A
Completed NCT02190890 - Dry Needling Dosage in the Treatment of Myofascial Neck Pain N/A
Completed NCT02051478 - Thoracic Manipulation and Mobilization for Neck Pain N/A
Completed NCT01938209 - A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT01233180 - Effects of Gua Sha and Thermotherapy on Chronic Neck Pain N/A