Dry Needling Versus Dry Cupping on Pain and Disability in Cervicogenic Headache Patients

November 13, 2024 updated by: Mariam Samara Elsaeed Shahen, Cairo University

This study aims to compare the added effects of dry needling and dry cupping to conventional physical therapy on headache pain intensity, headache frequency, headache duration, upper cervical range of motion, and disability levels in patients with cervicogenic headache.

It will be assumed that:

  • All patients will follow all the given instructions strictly during the study duration, regarding the assessment and the treatment procedure.
  • All participants will be evaluated under the same environmental conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neck pain is a highly popular musculoskeletal complain and the second most common musculoskeletal condition affecting people in their adolescence after low back pain. It is a common condition affecting general populations with high economic burden for neck pain including raised treatment costs, reduced productivity, and job-related problems. Headache is one of the most common disorders associated with neck pain with a potential for major disability.

Migraine, tension-type headache (TTH), and cervicogenic headache (CGH) are common types of headaches that negatively affect the quality of life, work activities, and family life. It has a direct or indirect economic burden on society.

Cervicogenic headache (CH) is a secondary headache caused by a disorder of the cervical spine and its disc or bony and/or periarticular components. In this type, pain originates from the back of neck and radiates towards the front of the head and eye on the same side. CGH can last from a few hours to days. The prevalence rate of CGH was estimated to be from 0.4% to 2.5% in the adult population and appears to affect women more than men.

The physiological mechanism of pain in CGH headache is the convergence of upper cervical spinal nerves (C1, C2, and C3) afferents and trigeminal afferents in the trigeminocervical nucleus caudalis. This convergence allows the bidirectional referral of painful sensations between the neck and trigeminal sensory receptive fields of the face and head.

Another cause of CGH is myofascial trigger points in the muscles. These trigger points, which are innervated by C1 to C3 (specifically in the suboccipital, semispinalis capitis, splenius cervices, trapezius, and sternocleidomastoid), can cause referral pain in various parts of the head.

Systematic review concluded that patients with CGH have significantly decreased cervical ROM and muscle function. Those patients have deep neck flexor weakness and tightness of the Sternocleidomastoid (SCM), trapezius and other muscles in the scapular region.

Management of CGH can involve a wide variety of therapeutic techniques, including medication, anesthetic and corticosteroid blocks, pulsed radiofrequency, cognitive therapy, relaxation therapy and physical therapy. Physical therapy interventions are recommended as nonpharmacological approaches for the treatment of CGH patients. These interventions include spinal manipulation, mobilization, manual therapy, dry needling, and therapeutic exercise.

Dry needling (DN) is an intervention method commonly used by physiotherapists for treatment of muscle pain associated with Trigger points (TrPsA). Acupuncture needles are placed directly into Muscle Trigger points (MTrPs) during this minimally invasive treatment. The benefits of DN include immediate relief in local, referred, and widespread pain and a restoration of range of motion and muscle activation patterns.

A previous study reported that the DN into the MTrPs of the suboccipital and upper trapezius muscles decreased headache index (HI), MTrP tenderness, increased functional rating index, and the range of motions in patients with CGH.

Cupping therapy (CT) is a physical traditional Chinese medicine (TCM) practiced by ancient Chinese, Egyptians, and Greeks and currently used by therapists and acupuncturists in the treatment of a wide range of medical conditions and played a vital role in human health. This alternative therapy involves creating a vacuum inside a cup positioned over the surface of the skin, using the local negative pressure to improve blood flow.

It has been used to treat various medical conditions, such as musculoskeletal injuries, dermatologic conditions, and chemical imbalances within the body. The most common use is reducing musculoskeletal or myofascial pain. It has been used to treat fibromyalgia, rheumatoid arthritis, neck and shoulder pain, and low back pain.

Cupping produces localized hyperemia to the applied area, The dilation of capillaries improves microcirculation which decreases muscle tone and promotes healing via metabolic changes.

Cupping therapy was the most preferred treatment method after herbal treatments in headache patients. Acupuncture and wet cupping method has a beneficial effect on pain intensity and cervical ROM in cervical headache patients when compared to shame acupuncture.

Moreover, a systematic review concluded that the evidence for dry needling and cupping is not greater than placebo in treatment of myofascial pain.

There is no study compare between effect of dry needling and dry cupping on cervicogenic headache patients.

Therefore, this study aims to compare between the effect of dry needling versus dry cupping on pain, Range of Motion (ROM) and level of disabilities in patients of cervicogenic headache.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The patients will be included in our study if they meet the following criteria:

    • Age between 25-45 years old for both genders.
    • No physiotherapy intervention for the last three months.
    • Intermittent headaches of varying duration and pain level at the rate of one headache per week for greater than 2 months.
    • Ipsilateral neck, shoulder, or arm pain.
    • Provocation of usual head pain by neck movement, sustained awkward neck positions or external pressure over the upper cervical or occipital region on the symptomatic side.
    • Limited neck ROM > 10 degrees confirmed by a positive Flexion Rotation Test.
    • Active trigger points (TrPs) within the suboccipital, upper trapezius or sternocleidomastoid muscles.

The diagnosis of active TrPs will be based on the major criteria proposed by):

  • Presence of a palpable taut band in a skeletal muscle
  • presence of a hypersensitive point in the taut band
  • local twitch response elicited by the snapping palpation of the taut band
  • reproduction of the referred pain in response to compression
  • patient recognition of the referred pain as a familiar symptom

Exclusion Criteria:

  • The patients will be excluded if they have:

    • Cervical radiculopathy.
    • History of neck, shoulder trauma or surgery.
    • Physical therapy intervention in the neck and shoulder region in the previous 3 months.
    • Vertebrobasilar insufficiency or vestibular dysfunctions.
    • Evidence of cognitive deficits.
    • Presence of any needle contraindication.
    • Presence of any cupping contraindication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Dry needling): The 15 patients will receive three dry needling sessions per week for four
Other: Group A (Dry Needling)
The patient will receive dry needling on suboccipital, upper trapezius and SCM muscles with conventional therapy 3 sessions per week for 4 weeks.
Experimental: Group B (Dry cupping): The 15 patients will receive three dry cupping sessions per week for four we
Other: Group B (Dry cupping)
Patients will receive dry cupping on suboccipital, upper trapezius and SCM muscles weeks with conventional therapy 3 sessions per week for 4 weeks.
Active Comparator: Group C (control): The 15 patients will receive standard exercise three sessions per week for four w
Other: Group C (control)
will receive standard exercise three sessions per week for four weeks. This standard regimen consists of the same exercises as group A and B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Range of Motion (CROM)
Time Frame: Pre- intervention and after 4 weeks of treatment
CROM device will be used for the assessment of upper cervical ROM.
Pre- intervention and after 4 weeks of treatment
The Arabic Version Of Neck Disability Index (NDI).
Time Frame: Pre- intervention and after 4 weeks of treatment
to assess the level of disabilities in patients with cervicogenic headache, in % points.
Pre- intervention and after 4 weeks of treatment
Headache impact test 6 items
Time Frame: Pre- intervention and after 4 weeks of treatment
used to assess headache severity.
Pre- intervention and after 4 weeks of treatment
Numerical pain rating scale
Time Frame: Pre- intervention and after 4 weeks of treatment
used to assess headache pain intenisty.
Pre- intervention and after 4 weeks of treatment
Pressure Algometer
Time Frame: Pre- intervention and after 4 weeks of treatment
used to assess trigger points pain pressure threshold
Pre- intervention and after 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 13, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.T.REC/012/005277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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