AzTrials
AzTrials

Dry NeedlingNCT06689371

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

A study testing Group A (Dry Needling) and Group B (Dry cupping) in people with Dry Needling and Dry Cupping, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Dry Needling, Dry Cupping, Cervicogenic Headache
What is being tested?
Group A (Dry Needling) and Group B (Dry cupping)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
13 Nov 2024to 1 Feb 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mariam samara Shahen, Demonstrator contact

+201024909968

msamara@horus.edu.eg

About this study

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.
Read the 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.

Being tested
Group A (Dry Needling), Group B (Dry cupping), Group C (control)
Medical subject headings
Post-Traumatic Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A (Dry Needling)Other

    The patient will receive dry needling on suboccipital, upper trapezius and SCM muscles with conventional therapy 3 sessions per week for 4 weeks.

  • Group B (Dry cupping)Other

    Patients will receive dry cupping on suboccipital, upper trapezius and SCM muscles weeks with conventional therapy 3 sessions per week for 4 weeks.

  • Group C (control)Other

    will receive standard exercise three sessions per week for four weeks. This standard regimen consists of the same exercises as group A and B.

Study groups in NCT06689371
Study groupRoleWhat they receive
Group A (Dry needling): The 15 patients will receive three dry needling sessions per week for fourExperimentalNot described
Receives: Other: Group A (Dry Needling)
Group B (Dry cupping): The 15 patients will receive three dry cupping sessions per week for four weExperimentalNot described
Receives: Other: Group B (Dry cupping)
Group C (control): The 15 patients will receive standard exercise three sessions per week for four wActive comparatorNot described
Receives: Other: Group C (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical Range of Motion (CROM)

    CROM device will be used for the assessment of upper cervical ROM.

    Measured: Pre- intervention and after 4 weeks of treatment

  2. The Arabic Version Of Neck Disability Index (NDI).

    to assess the level of disabilities in patients with cervicogenic headache, in % points.

    Measured: Pre- intervention and after 4 weeks of treatment

  3. Headache impact test 6 items

    used to assess headache severity.

    Measured: Pre- intervention and after 4 weeks of treatment

  4. Numerical pain rating scale

    used to assess headache pain intenisty.

    Measured: Pre- intervention and after 4 weeks of treatment

  5. Pressure Algometer

    used to assess trigger points pain pressure threshold

    Measured: Pre- intervention and after 4 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start13 Nov 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689371
Sponsor's protocol ID
R.T.REC/012/005277
Status last verified
Nov 2024
First submitted
13 Nov 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ahmed SM, Madbouly NH, Maklad SS, Abu-Shady EA. Immunomodulatory effects of blood letting cupping therapy in patients with rheumatoid arthritis. Egypt J Immunol. 2005;12(2):39-51.

    PubMed 17977209
  • Al-Bedah AMN, Elsubai IS, Qureshi NA, Aboushanab TS, Ali GIM, El-Olemy AT, Khalil AAH, Khalil MKM, Alqaed MS. The medical perspective of cupping therapy: Effects and mechanisms of action. J Tradit Complement Med. 2018 Apr 30;9(2):90-97. doi: 10.1016/j.jtcme.2018.03.003. eCollection 2019 Apr.

    PubMed 30963043
  • Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.

    PubMed 20436238
  • Berger AA, Liu Y, Mosel L, Champagne KA, Ruoff MT, Cornett EM, Kaye AD, Imani F, Shakeri A, Varrassi G, Viswanath O, Urits I. Efficacy of Dry Needling and Acupuncture in the Treatment of Neck Pain. Anesth Pain Med. 2021 Apr 3;11(2):e113627. doi: 10.5812/aapm.113627. eCollection 2021 Apr.

    PubMed 34336626
  • Bravo Petersen SM, Vardaxis VG. The flexion-rotation test performed actively and passively: a comparison of range of motion in patients with cervicogenic headache. J Man Manip Ther. 2015 May;23(2):61-7. doi: 10.1179/2042618614Y.0000000085.

    PubMed 26109826
  • Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.

    PubMed 23801002
  • Cardoso R, Seixas A, Rodrigues S, Moreira-Silva I, Ventura N, Azevedo J, Monsignori F. The effectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache: A Systematic Review of Randomized Trials. Arch Physiother. 2022 Sep 1;12(1):20. doi: 10.1186/s40945-022-00144-3.

    PubMed 36045409
  • Chys M, De Meulemeester K, De Greef I, Murillo C, Kindt W, Kouzouz Y, Lescroart B, Cagnie B. Clinical Effectiveness of Dry Needling in Patients with Musculoskeletal Pain-An Umbrella Review. J Clin Med. 2023 Feb 2;12(3):1205. doi: 10.3390/jcm12031205.

    PubMed 36769852
  • Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.

    PubMed 25143704
  • Ekhator C, Urbi A, Nduma BN, Ambe S, Fonkem E. Safety and Efficacy of Radiofrequency Ablation and Epidural Steroid Injection for Management of Cervicogenic Headaches and Neck Pain: Meta-Analysis and Literature Review. Cureus. 2023 Feb 13;15(2):e34932. doi: 10.7759/cureus.34932. eCollection 2023 Feb.

    PubMed 36938280
  • Fernandez-de-las-Penas C, Cuadrado ML, Arendt-Nielsen L, Simons DG, Pareja JA. Myofascial trigger points and sensitization: an updated pain model for tension-type headache. Cephalalgia. 2007 May;27(5):383-93. doi: 10.1111/j.1468-2982.2007.01295.x. Epub 2007 Mar 14.

    PubMed 17359516
  • France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.

    PubMed 24623124
  • Ge W, Leson C, Vukovic C. Dry cupping for plantar fasciitis: a randomized controlled trial. J Phys Ther Sci. 2017 May;29(5):859-862. doi: 10.1589/jpts.29.859. Epub 2017 May 16.

    PubMed 28603360
  • Ghods R, Sayfouri N, Ayati MH. Anatomical Features of the Interscapular Area Where Wet Cupping Therapy Is Done and Its Possible Relation to Acupuncture Meridians. J Acupunct Meridian Stud. 2016 Dec;9(6):290-296. doi: 10.1016/j.jams.2016.06.004. Epub 2016 Sep 15.

    PubMed 28010830
  • Gugliotti M, Tau J, Gallo K, Sagliocca N, Horan M, Sussman N, Wisnewski R. Between-week reliability of the cervical range of motion (CROM) device for upper cervical rotation. J Man Manip Ther. 2021 Jun;29(3):176-180. doi: 10.1080/10669817.2020.1805691. Epub 2020 Aug 18.

    PubMed 32808588

Questions about this trial

What is this clinical trial studying?

A study testing Group A (Dry Needling) and Group B (Dry cupping) in people with Dry Needling and Dry Cupping, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariam samara Shahen, Demonstrator (+201024909968, msamara@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Range of Motion (CROM) (time frame: Pre- intervention and after 4 weeks of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06689371, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in