scholarly journals Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache – a protocol of a pragmatic randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kiran Satpute ◽  
Nilima Bedekar ◽  
Toby Hall

Abstract Background Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH. Methods This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. An assessor blind to group allocation will measure outcomes pre-and post-intervention as well as 3 and 6 months after commencement of treatment. Participants will be allocated to one of the three groups: MMT and exercise; placebo and exercise; and exercise alone. The primary outcome measure is headache frequency. Secondary outcome measures are headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI). The intention-to-treat principle will be followed for statistical analysis. Between groups differences for all outcome measures at baseline and at reassessment points and 95% confidence intervals will be calculated using a mixed model ANOVA. Post hoc tests will be conducted to identify any significant difference between groups and over time. Discussion This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability. Limitations are that baseline evaluation of headache parameters may be affected by recall bias. External validity will be limited to the population with a minimum 1-year history of headache. The HADLI is not yet extensively evaluated for its psychometric properties and association between PPT and headache parameters is lacking. Performance bias is inevitable as a single therapist will be delivering all interventions. Trial registration The trial was registered prospectively under the Clinical Trial Registry India (Registration number: CTRI/2019/06/019506, dated on 03/06/2019). .

Cephalalgia ◽  
2017 ◽  
Vol 38 (10) ◽  
pp. 1672-1686 ◽  
Author(s):  
Maria-Eliza R Aguila ◽  
Trudy Rebbeck ◽  
Alun Pope ◽  
Karl Ng ◽  
Andrew M Leaver

Background Evidence on the medium-term clinical course of recurrent headaches is scarce. This study explored the six-month course and factors associated with non-improvement in migraine compared with tension-type headache and cervicogenic headache. Methods In this longitudinal cohort study, the six-month course of headaches was prospectively examined in participants (n = 37 with migraine; n = 42 with tension-type or cervicogenic headache). Participants underwent physical examination for cervical musculoskeletal impairments at baseline. Participants also completed questionnaires on pain, disability and other self-report measures at baseline and follow-up, and kept an electronic diary for 6 months. Course of headaches was examined using mixed within-between analyses of variance and Markov chain modeling. Multiple factors were evaluated as possible factors associated with non-improvement using regression analysis. Results Headache frequency, intensity, and activity interference in migraine and non-migraine headaches were generally stable over 6 months but showed month-to-month variations. Day-to-day variations were more volatile in the migraine than the non-migraine group, with the highest probability of transitioning from any headache state to no headache (probability = 0.82–0.85). The odds of non-improvement in disability was nearly six times higher with cervical joint dysfunction (odds ratio [95% CI] = 5.58 [1.14–27.42]). Conclusions Headache frequency, intensity, and activity interference change over 6 months, with day-to-day variation being more volatile in migraine than non-migraine headaches. Cervical joint dysfunction appears to be associated with non-improvement for disability in 6 months. These results may contribute to strategies for educating patients to help align their expectations with the nature of their headaches.


Cephalalgia ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 133-143 ◽  
Author(s):  
René F Castien ◽  
Daniëlle AWM van der Windt ◽  
Anneke Grooten ◽  
Joost Dekker

Objective: To evaluate the effectiveness of manual therapy (MT) in participants with chronic tension-type headache (CTTH). Subjects and Methods: We conducted a multicentre, pragmatic, randomised, clinical trial with partly blinded outcome assessment. Eighty-two participants with CTTH were randomly assigned to MT or to usual care by the general practitioner (GP). Primary outcome measures were frequency of headache and use of medication. Secondary outcome measures were severity of headache, disability and cervical function. Results: After 8 weeks ( n = 80) and 26 weeks ( n = 75), a significantly larger reduction of headache frequency was found for the MT group (mean difference at 8 weeks, −6.4 days; 95% CI −8.3 to −4.5; effect size, 1.6). Disability and cervical function showed significant differences in favour of the MT group at 8 weeks but were not significantly different at 26 weeks. Conclusions: Manual therapy is more effective than usual GP care in the short- and longer term in reducing symptoms of CTTH. Dutch Trial Registration no. TR 1074.


Cephalalgia ◽  
2006 ◽  
Vol 26 (8) ◽  
pp. 983-991 ◽  
Author(s):  
H van Ettekoven ◽  
C Lucas

We conducted a multicentre, randomized controlled trial with blinded outcome assessment. The treatment period was 6 weeks with follow-up assessment immediately thereafter and after 6 months. The objective was to determine the effectiveness of a craniocervical training programme combined with physiotherapy for tension-type headache. Eighty-one participants meeting the diagnostic criteria for tension-type headache were randomly assigned to an exercise group (physiotherapy and an additional craniocervical training programme) and a control group (physiotherapy alone). The primary outcome measure was headache frequency. Secondary outcomes included headache intensity and duration, Quality of Life (SF-36) and the Multidimensional Headache Locus of Control scale (MHLC). At 6 months' follow-up, the craniocervical training group showed significantly reduced headache frequency, intensity and duration ( P < 0.001 for all). Effect sizes were large and clinically relevant. Loss to follow-up amounted to 3.7±. Physiotherapy including craniocervical training reduces symptoms of tension-type headache significantly over a prolonged time frame.


Cephalalgia ◽  
2009 ◽  
Vol 29 (3) ◽  
pp. 365-372 ◽  
Author(s):  
SH Bø ◽  
EM Davidsen ◽  
P Gulbrandsen ◽  
E Dietrichs ◽  
G Bovim ◽  
...  

Cytokines have been measured in cerebrospinal fluid (CSF) from headache patients [infrequent episodic tension-type headache (TTH) and migraine with or without aura, all during attack, and cervicogenic headache] and compared with levels in pain-free individuals. Both proinflammatory [interleukin (IL)-1β, tumour necrosis factor-α and monocyte chemoattractant protein-1 (MCP-1)] and anti-inflammatory cytokines IL-1 receptor antagonist (IL-1ra), IL-4, IL-10 and transforming growth factor-β1 (TGF-β1)] were included. There were significant group differences in IL-1ra, TGF-β1 and MCP-1 in episodic TTH and migraine compared with controls, and a significant difference in MCP-1 between cervicogenic headache and migraine with aura. Intrathecal MCP-1 correlated with IL-1ra, IL-10 and TGF-β1 in episodic TTH, and MCP-1 with IL-10 in migraine with aura. Cytokine increases were modest compared with those often accompanying serious neurological conditions, and may represent a mild response to pain. We believe this to be the first comparative study of CSF cytokine levels in connection with headache.


2016 ◽  
Vol 33 (S1) ◽  
pp. S576-S576
Author(s):  
J. Connaughton ◽  
B. Wand

IntroductionHeadache is the most common pain reported by people with schizophrenia. Little research has been conducted into the characteristics and management of headaches in this population.ObjectivesDetermine the prevalence, type and management of headache in people with schizophrenia.AimsIdentify if best practice treatment of headache occurs and if changes are required to assure people receive appropriate management.MethodsOne hundred consecutive people with schizophrenia and schizoaffective disorder completed an extensive, reliable and valid headache questionnaire. Based on the questionnaire responses two clinicians independently classified each person's headache as either migraine headache (MH), tension type headache (TTH), cervicogenic headache (CGH) or other headache type (OH). Any discrepancies were resolved by consensus agreement.ResultsTwelve-month prevalence of headache (57%) was higher than the general population (46%) with no evidence of relationship between psychiatric clinical characteristics and presence of headache. Prevalence of CGH (5%) and MH (18%) were comparable to the general population. TTH (16%) had a lower prevalence. Nineteen percent of participant's headache was classified as OH type. No participant with MH was prescribed migraine specific medication. Only 1 of the 5 people whose headache was classified as CGH received manual therapy and none had been prescribed exercises. No people with TTH received manual therapy, exercise prescription or postural review.ConclusionsIt is recommended that education is required for patients and mental health workers about headache classification and the appropriate care pathways for different headache types.Disclosure of interestThe authors have not supplied their declaration of competing interest.


Cephalalgia ◽  
2010 ◽  
Vol 30 (12) ◽  
pp. 1426-1434 ◽  
Author(s):  
Jacques Bruijn ◽  
Hugo Duivenvoorden ◽  
Jan Passchier ◽  
Heiko Locher ◽  
Natascha Dijkstra ◽  
...  

Background: Riboflavin seems to have a promising effect on migraine in adults. The present study examines whether riboflavin has a prophylactic effect on migraine in children. Objective: To investigate whether riboflavin in a dosage of 50 mg/day has a prophylactic effect on migraine attacks in young children. Subjects and methods: This randomised, placebo-controlled, double-blind, cross-over trial included 42 children (aged 6–13 years) with migraine of whom 14 children were also suffering from tension-type headache. Following a 4-week baseline period, all children received placebo for 16 weeks then riboflavin for 16 weeks (or vice versa) with a washout period of 4 weeks in between. The primary outcome measure was reduction in mean frequency of migraine attacks and tension-type headache in the last 4 weeks at the end of the riboflavin and placebo phase, compared with the preceding baseline or wash-out period. Secondary outcome measures were mean severity and mean duration of migraine and tension-type headaches in the last 4 weeks at the end of the riboflavin and placebo phase, compared with the preceding baseline or wash-out period. Results: No significant difference in the reduction of mean frequency of migraine attacks in the last month of treatment was found between placebo and riboflavin ( P = 0.44). However, a significant difference in reduction of mean frequency of headaches with a tension-type phenotype was found in favour of the riboflavin treatment ( P = 0.04). Conclusions: In this group of children with migraine, there is no evidence that 50 mg riboflavin has a prophylactic effect on migraine attacks. We found some evidence that 50 mg riboflavin may have a prophylactic effect on interval headaches that may correspond to mild migraine attacks or tension-type headache attacks in children with migraine.


2019 ◽  
Vol 47 (7) ◽  
pp. 1654-1661 ◽  
Author(s):  
Alex Scott ◽  
Robert F. LaPrade ◽  
Kimberly G. Harmon ◽  
Giuseppe Filardo ◽  
Elizaveta Kon ◽  
...  

Background: A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. Purpose/Hypothesis: To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures—Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change—were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients’ global rating of change. Results: Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P—58 (29), 71 (20), and 80 (18); pain—4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change—4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). Conclusion: Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. Registration: NCT02116946 (ClinicalTrials.gov identifier).


2017 ◽  
Vol 25 (2) ◽  
pp. 246-255 ◽  
Author(s):  
Justin B McKee ◽  
Charles L Cottriall ◽  
John Elston ◽  
Simon Epps ◽  
Nikos Evangelou ◽  
...  

Background: Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel (ASIC). Objective: To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON). Methods: A total of 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial. Scanning laser polarimetry (GDx) at 6 months was the primary outcome measure and optical coherence tomography (OCT) and visual and electrophysiological measures were secondary outcome measures. Participants aged 18–55 years, ≤28 days of onset of first episode unilateral ON, were randomised to amiloride (10 mg daily for 5 months) or placebo ( clinicaltrials.gov , NCT 01802489). Results: Intention-to-treat (ITT) cohort consisted of 43 patients; 23 placebo and 20 amiloride. No significant drug-related adverse events occurred. No significant differences were found in GDx ( p = 0.840). Visual evoked potentials (VEP) were significantly prolonged in the amiloride group compared to placebo ( p = 0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer. Conclusion: Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm, but future neuroprotective trials in ON should target the window of opportunity to maximise potential neuroprotective benefit.


Author(s):  
Veena Bembalgi ◽  
Karkal Ravishankar Naik

AbstractTension type headache is the most widespread and most common primary headache disorder accounting for nearly 90% of all headaches. Efficacy of electromyography biofeedback in patients with tension type headache has been proven but efficacy of galvanic skin resistance biofeedback has not been studied adequately. The aim of the present study was to compare the efficacy of electromyography biofeedback and galvanic skin resistance biofeedback in patients with tension type headache.We performed a randomized single blinded controlled study. Out of 116 recruited subjects, 91 (59 females and 32 males) were randomly assigned to three groups receiving electromyography biofeedback (n=30), galvanic skin resistance biofeedback (n=30), and a control group (n=31). Each subject (except the control group) received 15 biofeedback sessions for 30 min each in an isolated room. The control group received only medication prescribed by their physician. Each patient was blinded to the type of biofeedback being given. Pain variables, SF-36 quality of life scores, and analgesic usage were recorded at baseline, 1 month, 6 months, and 1 year after therapy.There was a significant difference in frequency and duration of headache in electromyography and galvanic skin resistance groups (p<0.01), whereas the control group showed significant differences in intensity (p=0.05) and duration (p<0.001). Significant improvement was seen only in total SF-36 scores after 1 year in the electromyography and control groups (p=0.03 and p=0.00, respectively). A significant drop in analgesic usage was seen in all groups at 1 year (p<0.001).Electromyography and galvanic skin resistance biofeedback are effective in the treatment of tension type headache, with electromyography biofeedback being more effective than galvanic skin resistance biofeedback.


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