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Exercise and Manipulative Therapy for Older Persons With Headache

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Usual care intervention
Physiotherapy treatment
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Manual therapy, Exercise

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Physical Therapy, Faculty of Associated Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Usual care intervention

Physiotherapy treatment

Arm Description

Primary care as required including medication

Exercise and manipulative therapy

Outcomes

Primary Outcome Measures

Headache frequency
The number of headache frequency in the past week

Secondary Outcome Measures

Headache intensity
An average intensity in the past week will be rated on a 1-10 VAS
Headache duration
The number of hours of headache in the past week
Neck pain intensity
Intensity of neck pain will be measured using a 1-10 VAS
Neck pain and disability
Neck pain and disability will be measured using neck disability index (NDI-Thai version)
Quality of life
The Quality of life will be measured using SF-36 (Thai version)
Medication intake
type and dose of all medications taken by subjects will be recorded one week at baseline and prior to follow-up points on a medication diary
Global assessment of treatment benefit
Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)

Full Information

First Posted
November 22, 2012
Last Updated
January 26, 2016
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT01736774
Brief Title
Exercise and Manipulative Therapy for Older Persons With Headache
Official Title
A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Headache is a common health problem that affects quality of life in an older population and imposes substantial economic costs. Headache changes with age. Features of headache become less typical and neck pain is more frequently associated with headache in older persons. We recently demonstrated that the presence of cervical musculoskeletal impairment is not specific to cervicogenic headache (headache caused by the neck). Rather it was present in various frequent intermittent headache types in elders when compared to elders without headache. Changes in headache characteristics with age play an important role not only in diagnosis but also in treatment choice. Impairment in cervical musculoskeletal function found in older persons with headache has implications for headache management choices as the evidence indicates that physiotherapy management methods such as manual therapy and therapeutic exercise are an effective management approach for headache associated with the neck. Physiotherapy treatment would be a safe therapeutic option and may have a beneficial effect for elders with headache who have neck pain and concomitant cervical musculoskeletal dysfunction. This is particularly relevant as there are widespread concerns about medication overuse, adverse drug events and drug interactions in older persons. The effective management of older persons with headache in particular of those with atypical features of headache remains a challenge. Physiotherapy is indicated in those older persons diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headache. At present, 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. A clinical trial of treatment of cervical musculoskeletal impairment in older persons with various headache types may help guide management of headache in attempts to lesson medication use and cost in this population. Physiotherapy management may be a worthy treatment option particularly in older persons with headache who do not respond well to medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Manual therapy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care intervention
Arm Type
Experimental
Arm Description
Primary care as required including medication
Arm Title
Physiotherapy treatment
Arm Type
Experimental
Arm Description
Exercise and manipulative therapy
Intervention Type
Other
Intervention Name(s)
Usual care intervention
Intervention Description
The usual care intervention will include appropriate primary care as required including medication
Intervention Type
Other
Intervention Name(s)
Physiotherapy treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Headache frequency
Description
The number of headache frequency in the past week
Time Frame
Change from baseline in headache frequency at week 11 and 6 months after intervention
Secondary Outcome Measure Information:
Title
Headache intensity
Description
An average intensity in the past week will be rated on a 1-10 VAS
Time Frame
Change from baseline in headache intensity at week 11 and 6 months after intervention
Title
Headache duration
Description
The number of hours of headache in the past week
Time Frame
Change from baseline in headache duration at week 11 and 6 months after intervention
Title
Neck pain intensity
Description
Intensity of neck pain will be measured using a 1-10 VAS
Time Frame
Change from baseline in neck pain intensity at week 11 and 6 months after intervention
Title
Neck pain and disability
Description
Neck pain and disability will be measured using neck disability index (NDI-Thai version)
Time Frame
Change from baseline in neck pain and disability at week 11 and 6 months after intervention
Title
Quality of life
Description
The Quality of life will be measured using SF-36 (Thai version)
Time Frame
Change from baseline in quality of life at week 11 and 6 months after intervention
Title
Medication intake
Description
type and dose of all medications taken by subjects will be recorded one week at baseline and prior to follow-up points on a medication diary
Time Frame
Change from baseline in medication intake at week 11 and 6 months after intervention
Title
Global assessment of treatment benefit
Description
Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
Time Frame
Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sureeporn Uthaikhup, Ph.D.
Organizational Affiliation
Department of Physical Therapy, Faculty of Associated Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Faculty of Associated Medical Sciences
City
Chiang Mai
Country
Thailand

12. IPD Sharing Statement

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Exercise and Manipulative Therapy for Older Persons With Headache

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