NCT05658627

Brief Summary

It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

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 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

December 12, 2022

Last Update Submit

April 7, 2023

Conditions

Keywords

active release technique and cervicogenic headache

Outcome Measures

Primary Outcomes (3)

  • Assess the change in pain intensity level

    The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in rehabilitation.VAS is typically composed of a 100 mm horizontal line attached with two opposed labels, the left end marked "no pain" and the right end "severe intolerable pain".Patients will mark a score on the scale by a vertical line.

    Before treatment and after 4 weeks treatment

  • Assess the change in headache severity

    The headache impact test (HIT-6) : is a tool that subjectively evaluates the frequency of a patient's headache. The lowest score is 36, and the highest score is 78 for six items.Usually, if the score is over 59, it means the patient's daily life is severely affected by the headache.

    Before treatment and after 4 weeks treatment

  • Assess the change in pressure pain threshold

    Pressure algometry will be used to evaluate the (PPT) for suboccipital and hamstring muscles.In the prone position, the physician will apply 1 kg/s of pressure directly to suboccipital and hamstring muscles, the participant will speak up at the point where the pressure evoke a painful sensation, and the instantaneous value will be recorded as the PPT.

    Before treatment and after 4 weeks treatment

Secondary Outcomes (2)

  • Assess the change in Cervical flexion rotation test

    Before treatment and after 4 weeks treatment

  • Assess the change in Hamstrings flexibility

    Before treatment and after 4 weeks treatment

Study Arms (2)

1- control group

ACTIVE COMPARATOR

conventional physical therapy (ultrasound therapy- stretching exercise- strengthening exercise)

Other: conventional therapy

2- Experimental group

EXPERIMENTAL

Active release technique for hamstring+ conventional physical therapy(ultrasound therapy- stretching exercise- strengthening exercise)

Other: active release techniqueOther: conventional therapy

Interventions

Hamstring active release technique-

2- Experimental group

ultrasound therapy - stretching Exercise - Strengthening Exercise -

1- control group2- Experimental group

Eligibility Criteria

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

You may qualify if:

  • Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months.
  • Pain and tenderness at the upper cervical segment's palpation.
  • Movement restriction in cervical region, especially in the upper cervical rotation.
  • Positive SLR test for hamstring muscle less than 80â—¦.

You may not qualify if:

  • Malignancy.
  • Other types of headaches, including migraine, tension type, other serious headaches.
  • History of head and neck trauma or surgery.
  • Pregnancy.
  • Physiotherapy for headache in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.

    PMID: 25642072BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Wadida H Elsayed, Professor

    Cairo University

    STUDY CHAIR
  • Ghada A Mousa, Ass.prof

    Cairo University

    STUDY DIRECTOR
  • Hanaa K Atta, Lecturer

    Cairo University

    STUDY DIRECTOR
  • Nabil H El Agooz, Professor

    Al-Azhar University

    STUDY DIRECTOR

Central Study Contacts

Samar A Mohammed, Msc

CONTACT

Wadida H Elsayed, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 21, 2022

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share