Clinical trial NCT06689371: Dry Needling Versus Dry Cupping on Pain and Disability in Cervicogenic Headache Patients
Official title: Dry Needling Versus Dry Cupping on Pain and Disability in Cervicogenic Headache Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Needling
Dry Cupping
Cervicogenic Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical Range of Motion (CROM)
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: The Arabic Version Of Neck Disability Index (NDI).
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: Headache impact test 6 items
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: Numerical pain rating scale
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: Pressure Algometer
timeFrame: Pre- intervention and after 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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