Exercise and Manipulative Therapy for Older Persons With Headache

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Chiang Mai University
Sponsor:
Information provided by (Responsible Party):
Sureeporn Uthaikhup, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01736774
First received: November 22, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Headache
Other: Usual care intervention
Other: Physiotherapy treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: Change from baseline in headache frequency at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    The number of headache frequency in the past week


Secondary Outcome Measures:
  • Headache intensity [ Time Frame: Change from baseline in headache intensity at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    An average intensity in the past week will be rated on a 1-10 VAS

  • Headache duration [ Time Frame: Change from baseline in headache duration at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    The number of hours of headache in the past week

  • Neck pain intensity [ Time Frame: Change from baseline in neck pain intensity at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    Intensity of neck pain will be measured using a 1-10 VAS

  • Neck pain and disability [ Time Frame: Change from baseline in neck pain and disability at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    Neck pain and disability will be measured using neck disability index (NDI-Thai version)

  • Quality of life [ Time Frame: Change from baseline in quality of life at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    The Quality of life will be measured using SF-36 (Thai version)

  • Medication intake [ Time Frame: Change from baseline in medication intake at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention ] [ Designated as safety issue: No ]
    Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual care intervention
Primary care as required including medication
Other: Usual care intervention
The usual care intervention will include appropriate primary care as required including medication
Experimental: Physiotherapy treatment
Exercise and manipulative therapy
Other: Physiotherapy treatment
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)

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736774

Locations
Thailand
Department of Physical Therapy, Faculty of Associated Medical Sciences
Chiang Mai, Thailand
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Sureeporn Uthaikhup, Ph.D. Department of Physical Therapy, Faculty of Associated Medical Sciences
  More Information

No publications provided

Responsible Party: Sureeporn Uthaikhup, Principal Investigator, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01736774     History of Changes
Other Study ID Numbers: MRG5580145
Study First Received: November 22, 2012
Last Updated: November 28, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chiang Mai University:
Manual therapy
Exercise

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014