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Exercise and Manipulative Therapy for Older Persons With Headache

26 januari 2016 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

65

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Thailand
      • Chiang Mai, Thailand
        • Department of Physical Therapy, Faculty of Associated Medical Sciences

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Usual care intervention
Primary care as required including medication
Övrig: Usual care intervention
The usual care intervention will include appropriate primary care as required including medication
Experimentell: Physiotherapy treatment
Exercise and manipulative therapy
Övrig: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Headache frequency
Tidsram: Change from baseline in headache frequency at week 11 and 6 months after intervention
The number of headache frequency in the past week
Change from baseline in headache frequency at week 11 and 6 months after intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Headache intensity
Tidsram: Change from baseline in headache intensity at week 11 and 6 months after intervention
An average intensity in the past week will be rated on a 1-10 VAS
Change from baseline in headache intensity at week 11 and 6 months after intervention
Headache duration
Tidsram: Change from baseline in headache duration at week 11 and 6 months after intervention
The number of hours of headache in the past week
Change from baseline in headache duration at week 11 and 6 months after intervention
Neck pain intensity
Tidsram: Change from baseline in neck pain intensity at week 11 and 6 months after intervention
Intensity of neck pain will be measured using a 1-10 VAS
Change from baseline in neck pain intensity at week 11 and 6 months after intervention
Neck pain and disability
Tidsram: Change from baseline in neck pain and disability at week 11 and 6 months after intervention
Neck pain and disability will be measured using neck disability index (NDI-Thai version)
Change from baseline in neck pain and disability at week 11 and 6 months after intervention
Quality of life
Tidsram: Change from baseline in quality of life at week 11 and 6 months after intervention
The Quality of life will be measured using SF-36 (Thai version)
Change from baseline in quality of life at week 11 and 6 months after intervention
Medication intake
Tidsram: Change from baseline in medication intake at week 11 and 6 months after intervention
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
Change from baseline in medication intake at week 11 and 6 months after intervention
Global assessment of treatment benefit
Tidsram: Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention
Patients perceived benefit of treatment will be measured on a scale from 0 (no benefit) to 10 (maximum benefit)
Changes from baseline in global assessment of treatment benefit at week 11 and 6 months after intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chiang Mai University

Utredare

  • Huvudutredare: Sureeporn Uthaikhup, Ph.D., Department of Physical Therapy, Faculty of Associated Medical Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2012

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 juli 2015

Studieregistreringsdatum

Först inskickad

22 november 2012

Först inskickad som uppfyllde QC-kriterierna

26 november 2012

Första postat (Uppskatta)

29 november 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 januari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 januari 2016

Senast verifierad

1 januari 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MRG5580145

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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