Effectiveness of Dry Needling in People With Episodic Tension-type Headache

NCT05493098 | Unknown

• 1 other identifier: IR.IUMS.REC.1400.30
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tension-type headache is a widespread disorder, with a lifetime prevalence in the general population ranging between 30% and 78%. Tension-type headache also places a financial burden on society and individuals. Myofascial pain can reduce the range of motion and patterns of muscle activation and play an important role in tension-type headache. Based on the previous studies, dry needling can reduce local and referred pain, increase range of motion and improve patterns of muscle activation in patients with myofascial pain syndrome. The effectiveness of dry needling in patients with tension-type headache is not fully known. Objective: The aim of this study will be to investigate the effectiveness of dry needling on pain, active range of motion, functional disability, and frequency of headache in patients with episodic tension-type headache. Method: This study will be a double-blind randomized controlled trial. Thirty-six patients with episodic tension-type headache will be randomly divided into two groups: the experimental group (dry needling and routine physical therapy) and the control group (sham dry needling and routine physical therapy). The primary outcomes will be pain intensity and active range of motion of the craniocervical region. Functional disability and frequency of headache will be considered secondary outcomes. Outcomes will be assessed before and one week after the intervention.

Conditions

Episodic Tension-type Headache

Keywords

dry needling; tension-type headache; myofascial pain syndrome

Outcome Measures

Primary Outcomes (2)

• Pain level

  0-100 Numeric Pain Rating Scale will be used to evaluate changes in level of pain from the baseline to one week after the intervention. Zero indicates no pain and 100 indicates maximum pain that the patient experiences.

  Change between baseline and one week after intervention.

• Active craniocervical range of motion

  Active craniocervical range of motion of the participants with episodic tension-type headache will be measured using a SAEHAN plastic universal two-arm goniometer with 360° goniometer face and 30-cm (11.81- in) movable arms. For measuring active flexion, extension, lateral flexion, and rotation, the participants will be asked to sit upright on a chair with a padded backrest supporting the thoracic spine with their feet flat on the floor and arms positioned comfortably on the armrests beside them. To minimize the contribution of the thoracic spine, the participant will be securely strapped across the shoulders to the chair using an inelastic belt. All the measured angles will be documented by a third person. The movements will be measured in the following sequences: flexion, extension, left lateral flexion, right lateral flexion, left rotation, and right rotation.

  Change between baseline and one week after intervention.

Secondary Outcomes (2)

• Functional disability

  Change between baseline and one week after intervention.

• Frequency of headache:

  Change between baseline and one week after intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will include 18 participants with episodic tension-type headache. The treatment will include dry needling of the suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis, and cervicis, frontalis, and temporalis muscles and routine physical therapy. The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes. In each session, three muscles from one side will be needled. Routine physical therapy will include information on nature, management, course of episodic tension-type headaches, and Multimodal care that includes craniocervical exercises and postural correction. The treatment will last two weeks, six sessions, three times a week.

Other: dry needling

Control group

PLACEBO COMPARATOR

The control group will include 18 participants with episodic tension-type headache. The treatment will include "sham" dry needling of the suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis, and cervicis, frontalis and temporalis muscles and routine physical therapy. The sham dry needling method includes the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes. In each session, three muscles from one side will be needled. Routine physical therapy will include information on nature, management, course of episodic tension-type headaches, and Multimodal care that includes craniocervical exercises and postural correction. The treatment will last two weeks, six sessions, three times a week.

Other: sham (placebo) dry needling:

Interventions

dry needling OTHER

The method of performing the dry needling technique will be based on the methods presented by Dommerholt and Fernandez-de-Las-Penas. One length of sterile, disposable 0.30 mm x 30 mm solid filament needle (Tony, China) will be used. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted to obtain local twitch response, and this process will continue until no more Dry needling: The method of performing the dry needling technique will be based on the methods presented by Dommerholt and Fernandez-de-Las-Penas. One length of sterile, disposable 0.30 mm x 30 mm solid filament needle (Tony, China) will be used. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes.

Experimental group

sham (placebo) dry needling: OTHER

The sham dry needling method includes the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes.

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of CTTH based on the International Classification of Headache Disorders, 3rd edition
• At least one active trigger point in each of the muscles of the sub occipital, sternocleidomastoid, upper trapezius, temporalis, levator scapula, masseter, frontalis, and splenius cervicis and capitis
• Moderate pain intensity from 30 to 60 based on the numeric pain rating scale

You may not qualify if:

• Needle phobia
• History of surgery on head, neck, and shoulder
• pregnancy
• cancer, infectious diseases, or systemic diseases
• History of involvement with other types of primary headaches
• History of neck radiculopathy and other orthopedic neck injuries (including fractures, facet joint syndrome, etc.) in the past year.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Related Publications (18)

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MeSH Terms

Conditions

Tension-Type Headache; Myofascial Pain Syndromes

Interventions

Dry Needling; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Alireza Gandomidokht, bachelor

CONTACT

0098-09192454744; alirezagd76@gmail.com

Mohammadreza Pourahmadi, PhD

CONTACT

0098-09122245593; pourahmadipt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 9, 2022
• Study Start: June 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share