NCT06689371

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 13, 2024

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Cervical Range of Motion (CROM)

    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).

    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

    used to assess headache severity.

    Pre- intervention and after 4 weeks of treatment

  • Numerical pain rating scale

    used to assess headache pain intenisty.

    Pre- intervention and after 4 weeks of treatment

  • Pressure Algometer

    used to assess trigger points pain pressure threshold

    Pre- intervention and after 4 weeks of treatment

Study Arms (3)

Group A (Dry needling): The 15 patients will receive three dry needling sessions per week for four

EXPERIMENTAL
Other: Group A (Dry Needling)

Group B (Dry cupping): The 15 patients will receive three dry cupping sessions per week for four we

EXPERIMENTAL
Other: Group B (Dry cupping)

Group C (control): The 15 patients will receive standard exercise three sessions per week for four w

ACTIVE COMPARATOR
Other: Group C (control)

Interventions

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

Group A (Dry needling): The 15 patients will receive three dry needling sessions per week for four

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

Group B (Dry cupping): The 15 patients will receive three dry cupping sessions per week for four we

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

Group C (control): The 15 patients will receive standard exercise three sessions per week for four w

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (44)

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MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Mariam samara Shahen, Demonstrator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrater

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 14, 2024

Study Start

November 13, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

November 14, 2024

Record last verified: 2024-11