Dataset Information

Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial.

ABSTRACT:

Background

The effectiveness of manipulation versus mobilization for the management of spinal conditions, including cervicogenic headache, is conflicting. However, a pragmatic approach comparing manipulation to mobilization has not been examined in a patient population with cervicogenic headache.

Objectives

To evaluate the effectiveness of manipulation compared to mobilization applied in a pragmatic fashion for patients with cervicogenic headache.

Methods

Forty-five (26 females) patients with cervicogenic headache (mean age 47.8 ± SD 16.9 years) were randomly assigned to receive either pragmatically selected manipulation or mobilization. Outcomes were measured at baseline, the second visit, discharge, and 1-month follow-up and included the Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), the Headache Impact Test (HIT-6), the Global Rating of Change (GRC), the Patient Acceptable Symptoms Scale (PASS). The primary aim (effects of treatment on disability and pain were examined with a mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization) as the between subjects variable and time (baseline, 48 hours, discharge and follow-up) as the within subjects variable.

Results

The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89). There was no significant difference between groups for the GRC or PASS.

Discussion and conclusion

The results suggest that manipulation has similar effects on disability, pain, GRC, and cervical range of motion as mobilization when applied in a pragmatic fashion for patients with cervicogenic headaches.

Clinicaltrials.gov

NCT03919630.

SUBMITTER: Lerner-Lentz A

PROVIDER: S-EPMC8491670 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Although commonly utilized interventions, no studies have directly compared the effectiveness of cervical and thoracic manipulation to mobilization and exercise in individuals with cervicogenic headache (CH). The purpose of this study was to compare the effects of manipulation to mobilization and exercise in individuals with CH.One hundred and ten participants (n = 110) with CH were randomized to receive both cervical and thoracic manipulation (n = 58) or mobilization and exercise (n = 52). The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale (NPRS). Secondary outcomes included headache frequency, headache duration, disability as measured by the Neck Disability Index (NDI), medication intake, and the Global Rating of Change (GRC). The treatment period was 4 weeks with follow-up assessment at 1 week, 4 weeks, and 3 months after initial treatment session. The primary aim was examined with a 2-way mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between subjects variable and time (baseline, 1 week, 4 weeks and 3 months) as the within subjects variable.The 2X4 ANOVA demonstrated that individuals with CH who received both cervical and thoracic manipulation experienced significantly greater reductions in headache intensity (p < 0.001) and disability (p < 0.001) than those who received mobilization and exercise at a 3-month follow-up. Individuals in the upper cervical and upper thoracic manipulation group also experienced less frequent headaches and shorter duration of headaches at each follow-up period (p < 0.001 for all). Additionally, patient perceived improvement was significantly greater at 1 and 4-week follow-up periods in favor of the manipulation group (p < 0.001).Six to eight sessions of upper cervical and upper thoracic manipulation were shown to be more effective than mobilization and exercise in patients with CH, and the effects were maintained at 3 months.NCT01580280 April 16, 2012.

Project description:BACKGROUND CONTEXT:The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown. PURPOSE:The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control. STUDY DESIGN/SETTING:This is a two-site, open-label randomized controlled trial. PATIENT SAMPLE:Participants were 256 adults with chronic CGH. OUTCOME MEASURES:The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. METHODS:Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest. RESULTS:A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome. CONCLUSIONS:There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control.

Project description:BackgroundTo investigate the feasibility and effect of a multimodal program for improving chronic cervicogenic headache (CGH) via the addition of sagittal cervical spine alignment correction.DesignPilot, parallel-group, randomized controlled trial.Participants60 patients with CGH, straightening of the cervical lordosis, and forward head posture (FHP) were randomly assigned using permuted-block randomization either to a control (n = 30) or an experimental group (n = 30).InterventionsSubjects in both groups received a multimodal program where the denneroll cervical spine extension traction orthotic was added to the experimental group only. Feasibility was assessed through recruitment rate, compliance rate, adherence rate, safety, and global satisfaction in addition to clinical outcome measures: FHP distance, cervical lordosis, headache frequency, headache disability inventory (HDI), headache impact test-6 (HIT-6), and daily defined dose (DDD). Evaluations were performed at: baseline, 10 weeks, 1 year follow up, and 2-year follow up. The assessor was blind to group allocation for all measured outcomes.ResultsThe recruitment rate was 60%, 78 % out of them completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded and greater overall satisfaction with the interventions was reported. Greater improvements were found for the experimental group's cervical lordosis (f = 259.9, P< < .001) and FHP (f = 142.5, P< < .001). At 10 weeks, both groups showed equal improvements in CGH outcomes: headache frequency (P = 0.07), HDI (P = 0.07), HIT-6 (P = .2), and DDD (P = .3). In contrast, at the 1-year and 2-year follow up, between group differences were found for all CGH outcomes, P < .00, indicating greater improvement in the experimental group.ConclusionThe results indicated feasibility for recruitment rate, compliance rate, exercise session adherence, safety, and global satisfaction. At 1-year and 2-year follow-up, the addition of the denneroll orthotic device revealed positive influence on CGH management outcomes.Trial registrationThe trial was retrospectively registered with the Pan African Clinical Trial Registry (PACTR201605001650300).

Project description:STUDY DESIGN:Pilot randomized controlled trial. BACKGROUND:Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. METHODS:Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. RESULTS:Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. CONCLUSIONS:Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. TRIAL REGISTRATION:Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true.