NCT01736774

Brief Summary

The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache but other various frequent intermittent headache types (i.e. migraine and tension-type headache) in the elderly population. There has been no trial to date which has investigated the effectiveness of physiotherapy treatment specifically for older persons with various types of headache with associated neck pain and cervical musculoskeletal impairment. Thus, the purpose of study investigate the efficacy of physiotherapy treatment for older persons who have headache concomitant with neck pain and musculoskeletal impairment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration 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

November 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

November 22, 2012

Last Update Submit

January 26, 2016

Conditions

Headache

Keywords

Manual therapyExercise

Outcome Measures

Primary Outcomes (1)

  • Headache frequency

    The number of headache frequency in the past week

    Change from baseline in headache frequency at week 11 and 6 months after intervention

Secondary Outcomes (7)

  • Headache intensity

    Change from baseline in headache intensity at week 11 and 6 months after intervention

  • Headache duration

    Change from baseline in headache duration at week 11 and 6 months after intervention

  • Neck pain intensity

    Change from baseline in neck pain intensity at week 11 and 6 months after intervention

  • Neck pain and disability

    Change from baseline in neck pain and disability at week 11 and 6 months after intervention

  • Quality of life

    Change from baseline in quality of life at week 11 and 6 months after intervention

  • +2 more secondary outcomes

Study Arms (2)

Usual care intervention

EXPERIMENTAL

Primary care as required including medication

Other: Usual care intervention

Physiotherapy treatment

EXPERIMENTAL

Exercise and manipulative therapy

Other: Physiotherapy treatment

Interventions

Usual care interventionOTHER

The usual care intervention will include appropriate primary care as required including medication

Usual care intervention
Physiotherapy treatmentOTHER

Exercise and manipulative therapy treatment for 10 weeks:The treatment intervention consists of two visits per week for the first four weeks (8 treatments) and one visit per week for the last six weeks (6 treatments)

Physiotherapy treatment

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers suffering from frequent intermittent headache (either migraine, tension-type headache or cervicogenic headache) at least one per month over a period of 3 months or longer
  • Aged 50 years or older, female or male
  • A score of ≥ 3/10 on visual analogue scale (VAS) of neck pain
  • Evidence of cervical musculoskeletal impairment: restriction in active range of cervical motion in extension and rotation and join tenderness in at least one of the upper joint as detected by manual palpation

You may not qualify if:

  • Headache diagnosed as following: temporal arteritis, trigeminal neuralgia, cluster headache, chronic paroxysmal hemicrania/hemicranias continua, temporomandibular joint dysfunction
  • Other diagnosed disorders: cerebrovascular disease, Parkinson disease, cognitive disturbance
  • Previous history of head or neck surgery
  • Lack of willingness to receive either pragmatic treatment or usual care
  • Physiotherapy or chiropractic treatment for headache in previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

HeadacheMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Sureeporn Uthaikhup, Ph.D.

    Department of Physical Therapy, Faculty of Associated Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 29, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

TH(1)