- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01736774
Exercise and Manipulative Therapy for Older Persons With Headache
2016년 1월 26일 업데이트: Sureeporn Uthaikhup, Chiang Mai University
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
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
65
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Chiang Mai, 태국
- Department of Physical Therapy, Faculty of Associated Medical Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Usual care intervention
Primary care as required including medication
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The usual care intervention will include appropriate primary care as required including medication
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실험적: Physiotherapy treatment
Exercise and manipulative therapy
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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)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Headache frequency
기간: Change from baseline in headache frequency at week 11 and 6 months after intervention
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The number of headache frequency in the past week
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Change from baseline in headache frequency at week 11 and 6 months after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Headache intensity
기간: Change from baseline in headache intensity at week 11 and 6 months after intervention
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An average intensity in the past week will be rated on a 1-10 VAS
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Change from baseline in headache intensity at week 11 and 6 months after intervention
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Headache duration
기간: Change from baseline in headache duration at week 11 and 6 months after intervention
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The number of hours of headache in the past week
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Change from baseline in headache duration at week 11 and 6 months after intervention
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Neck pain intensity
기간: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Intensity of neck pain will be measured using a 1-10 VAS
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Change from baseline in neck pain intensity at week 11 and 6 months after intervention
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Neck pain and disability
기간: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Neck pain and disability will be measured using neck disability index (NDI-Thai version)
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Change from baseline in neck pain and disability at week 11 and 6 months after intervention
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Quality of life
기간: Change from baseline in quality of life at week 11 and 6 months after intervention
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The Quality of life will be measured using SF-36 (Thai version)
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Change from baseline in quality of life at week 11 and 6 months after intervention
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Medication intake
기간: Change from baseline in medication intake at week 11 and 6 months after intervention
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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
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Change from baseline in medication intake at week 11 and 6 months after intervention
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Global assessment of treatment benefit
기간: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
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Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sureeporn Uthaikhup, Ph.D., Department of Physical Therapy, Faculty of Associated Medical Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 12월 1일
기본 완료 (실제)
2014년 12월 1일
연구 완료 (실제)
2015년 7월 1일
연구 등록 날짜
최초 제출
2012년 11월 22일
QC 기준을 충족하는 최초 제출
2012년 11월 26일
처음 게시됨 (추정)
2012년 11월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 1월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 1월 26일
마지막으로 확인됨
2016년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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