HeadacheNCT01736774
Exercise and Manipulative Therapy for Older Persons With Headache
A study testing Physiotherapy treatment in people with Headache, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Headache
- What is being tested?
- Physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Physical Therapy, Faculty of Associated Medical Sciences
Chiang Mai
About this study
Official title: A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
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
Read the 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.
- Conditions
- Headache
- Being tested
- Usual care intervention, Physiotherapy treatment
- Keywords
- Manual therapy, Exercise
- Medical subject headings
- Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care interventionOther
The usual care intervention will include appropriate primary care as required including medication
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)
| Study group | Role | What they receive |
|---|---|---|
| Usual care intervention | Experimental | Primary care as required including medication Receives: Other: Usual care intervention |
| Physiotherapy treatment | Experimental | Exercise and manipulative therapy Receives: Other: Physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
The number of headache frequency in the past week
Measured: Change from baseline in headache frequency at week 11 and 6 months after intervention
Secondary outcomes (7)
Headache intensity
An average intensity in the past week will be rated on a 1-10 VAS
Measured: Change from baseline in headache intensity at week 11 and 6 months after intervention
Headache duration
The number of hours of headache in the past week
Measured: Change from baseline in headache duration at week 11 and 6 months after intervention
Neck pain intensity
Intensity of neck pain will be measured using a 1-10 VAS
Measured: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
Neck pain and disability
Neck pain and disability will be measured using neck disability index (NDI-Thai version)
Measured: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
Quality of life
The Quality of life will be measured using SF-36 (Thai version)
Measured: Change from baseline in quality of life at week 11 and 6 months after intervention
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
Measured: Change from baseline in medication intake at week 11 and 6 months after intervention
Global assessment of treatment benefit
Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
Measured: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sureeporn Uthaikhup, Chiang Mai University
- Investigators
- Sureeporn Uthaikhup, Ph.D., Principal investigator, Department of Physical Therapy, Faculty of Associated Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736774
- Sponsor's protocol ID
- MRG5580145
- Status last verified
- Jan 2016
- First submitted
- 22 Nov 2012
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Exercise and Manipulative Therapy for Older Persons With Frequent Intermittent Headaches Associated With Neck Pain and Impairment
- ClinicalTrials.gov ID
- NCT01736774
- Acronym / sponsor ID
- MRG5580145
- Conditions
- Headache
- Keywords
- Manual therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care intervention | Experimental | Other: Usual care interventionPrimary care as required including medication |
| Physiotherapy treatment | Experimental | Other: Physiotherapy treatmentExercise and manipulative therapy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care interventionThe usual care intervention will include appropriate primary care as required including medication | Other | Usual care intervention |
| Physiotherapy treatmentExercise 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) | Other | Physiotherapy treatment |
Primary outcome
Headache frequency
Time frame: Change from baseline in headache frequency at week 11 and 6 months after intervention
The number of headache frequency in the past week
7 secondary outcomes
Headache intensity
Time frame: Change from baseline in headache intensity at week 11 and 6 months after intervention
Headache duration
Time frame: Change from baseline in headache duration at week 11 and 6 months after intervention
Neck pain intensity
Time frame: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
Neck pain and disability
Time frame: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
Quality of life
Time frame: Change from baseline in quality of life at week 11 and 6 months after intervention
Medication intake
Time frame: Change from baseline in medication intake at week 11 and 6 months after intervention
Global assessment of treatment benefit
Time frame: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sureeporn Uthaikhup, Ph.D. principal investigator
Department of Physical Therapy, Faculty of Associated Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy treatment in people with Headache, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: Change from baseline in headache frequency at week 11 and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.