A Randomized, Placebo-Controlled Clinical Trial of Chiropractic and Medical Prophylactic Treatment of Adults With Tension-Type Headache: Results From a Stopped Trial
Notice bibliographique
Résumé
OBJECTIVES: Tension-type headache (TTH) is the most common headache experienced by adults in Western society. Only 2 clinical trials of spinal manipulation for adult tension-type headache have been reported, neither of which was fully controlled. In 1 trial, spinal manipulation was compared to amitriptyline. There is an urgent need for well-controlled studies of chiropractic spinal manipulation for TTH. This trial was stopped prematurely due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, as it contained several novel features, (2) to report the limited data set obtained from our sample of completed subjects, and (3) to discuss the problems that were encountered in conducting this study. METHODS: A randomized clinical trial was conducted with a factorial design in which adult TTH sufferers with more than 10 headaches per month were randomly assigned to four groups: real cervical manipulation + real amitriptyline, real cervical manipulation + placebo amitriptyline, sham cervical manipulation + real amitriptyline, and sham cervical manipulation + placebo amitriptyline. A baseline period of four weeks was followed by a treatment period of 14 weeks. The primary outcome was headache frequency obtained from a headache diary in the last 28 days of the treatment period. RESULTS: Nineteen subjects completed the trial. In the unadjusted analysis, a statistically significant main effect of chiropractic treatment was obtained (-2.2 [-10.2 to 5.8], P = .03) which was just below the 3-day reduction set for clinical importance. As well, a clinically important [corrected] effect of the combined therapies was obtained (-9 [-20.8 [corrected] to 2.9], P = .13), but this did not achieve statistical significance. In the adjusted analysis, neither the main effects of chiropractic nor amitriptyline were statistically significant or clinically important; however, the effect of the combined treatments was -8.4 (-15.8 to -1.1) which was statistically significant (P = .03) and reached our criterion for clinical importance. CONCLUSION: Although the sample size was smaller than initially required, a statistically significant and clinically important effect was obtained for the combined treatment group. There are considerable difficulties with recruitment of subjects in such a trial. This trial should be replicated with a larger sample.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».