NCT05952115

Brief Summary

this study will be conducted to investigate the effect of lumbar motor control training exercise on headache frequency, duration, intensity and neck functional disability in cervicogenic headache patients

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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

July 11, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 16, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 11, 2023

Last Update Submit

July 11, 2023

Conditions

Keywords

lumbar motor controlcervicogenic hedachecervical stabilization exercises

Outcome Measures

Primary Outcomes (3)

  • Headache frequency:

    Headache frequency will measure as the number of days with headache in the last week, ranging from 0 to 7 days

    up to four weeks

  • Headache duration

    Headache duration will measure in total hours and average number of hours headaches lasted in the past week

    up to four weeks

  • Headache intensity

    The Visual Analog Scale will use to quantify the patient's pain level or intensity. these scale consists of line, usually 10 cm long, ranging from no pain at one end and worst pain at the other end

    up to four weeks

Secondary Outcomes (1)

  • neck disability

    up to four weeks

Study Arms (2)

lumbar motor control exercises

EXPERIMENTAL

patients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks

Other: lumbar motor control exercisesOther: Cervical stabilization exercises

cervical stabilization exercises

ACTIVE COMPARATOR

the patients will receive cervical stabilization exercises three times a week for four weeks

Other: Cervical stabilization exercises

Interventions

the patients will receive lumbar motor control exercises in the form of three exercises (Abdominal draw in maneuver, side-bridge, and quadruped) and the level of difficulty increased each week. For all exercises, the number of repetitions stayed the same, but the difficulty increased each week, and we progressed to the advanced level of each of the three exercises. This training achieves co-contraction of the local/deep stabilizing muscles (Transversus abdominis and multifidus) and strengthening the global/large spinal stabilizers (erector spinae and obliques).

lumbar motor control exercises

The exercise program consisted of an axial elongation exercise, cranio-cervical flexion exercise, cervical extension exercise, and cervical-scapulothoracic strengthening exercise. The exercise program progressed based on the exercise tolerance of the patients by increasing the repetition of the exercise (10 reps to 15 reps to 20 reps). And for the resistive exercise, the participants change to an elastic band with greater resistance (progress to the next color resistance band). Exercises were performed for 20 min/session, and an exercise log recording the date and repetition of the exercises was maintained by the therapist for each participant.

cervical stabilization exerciseslumbar motor control exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age of the subjects ranged from 20-40 years old, both genders.
  • Patients with chronic mechanical neck pain with frequent cervicogenic headaches persisting for more than 3 months.
  • Positive flexion rotation test.
  • Unilateral head pain without side shift or bilateral head pain with dominant side headache associated with neck pain and aggravated by neck movement and/or sustained awkward head positioning
  • Joint tenderness in at least one of the upper three cervical joints or the occipital region as detected by manual palpation.
  • Intensity of headache is moderate to severe.
  • Abnormal performance in CCFT \< = 26 mmHg
  • Body mass index range from 18 to 25 km/m2

You may not qualify if:

  • Fracture or previous surgery on the vertebral column.
  • Spinal stenosis.
  • Disc prolapsed.
  • TMJ dysfunction.
  • Headache with autonomic involvement, dizziness, or visual disturbance.
  • Congenital condition of the cervical spine.
  • Neck pain of less than three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: lumbar motor control and cervical stabilization exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator hagar Abd El basset Ismail Marzouk

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

July 16, 2023

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07