NCT06733896

Brief Summary

Sternocleidomastoid syndrome is often characterized by referred pain in other areas. Like all muscles, the SCM can develop tight, and non-contracting bands called trigger points that can refer pain elsewhere. For the SCM, the trigger point referral areas are the eye and forehead, the back of the head (occiput), front of the neck, cheek, and side of the head. Trigger points can be treated by direct manual massage, dry needling, or platelet-poor plasma injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

December 5, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

trigger pointssternocleidomastoidheadaches

Outcome Measures

Primary Outcomes (1)

  • cervical neck pain

    visual analogue scale: This pain scale is most commonly used. A person rates their pain on a scale of 0 to 10 or 0 to 5. Zero means "no pain," and 5 or 10 means "the worst possible pain." These pain intensity levels may be assessed upon initial treatment, or periodically after treatment.

    4 weeks

Secondary Outcomes (2)

  • biodex balance system

    4 weeks

  • neck stability index

    4 weeks

Study Arms (2)

study group

EXPERIMENTAL
Other: trigger point pressure

control group

ACTIVE COMPARATOR
Other: neck exercises

Interventions

The midpoint of the sternocleidomastoid muscle with abundant nerve distribution and the onset and endpoint of the sternocleidomastoid muscle were used as acupoints, which can relieve localised muscle spasms and promote nerve nutrition.

study group

Manual Cervical Traction Technique and others

control group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of CGH ≥ 3 months at Baseline 1, ≥5 days of CGH per month
  • CGH intensity ≥3 (0-10 scale)
  • Cervical spine dysfunction (cervical joint tenderness and/or restricted segmental motion)
  • Clear temporal sequence linking the source of CGH to the neck: headache preceded by neck pain, stiffness, movement and/or awkward postures

You may not qualify if:

  • Other headaches within one year of enrollment (e.g. migraine occurring on \>1 day per month in the last year, medication overuse, daily, cluster, temporomandibular joint dysfunction related headaches, sinus, posttraumatic, tumor and glaucoma related, occipital neuralgia, metabolic/toxic/substance abuse related).
  • Spinal manipulative therapy, massage or exercise therapy for neck pain or headaches in the previous 3 months. Any other types of care by a licensed provider in the previous month for headaches or neck pain
  • Contraindications to study treatments (e.g., inflammatory arthropathies, cervical instability, severe osteoporosis, vertigo, dizziness)
  • Daily prescription or nonprescription pain medication; corticosteroid use in previous month
  • Cancer in the past five years
  • ear problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umm Al Qura University

Mecca, Saudi Arabia

Location

Related Links

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
associate professor hanan hosny M Battesha

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 13, 2024

Study Start

January 1, 2025

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations