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Study Title and Description

Nonpharmacological management of headaches during pregnancy.



Key Questions Addressed
2 Direct Evidence (Primary Studies): KQ 2 - What are the (comparative) benefits and harms of interventions to treat acute attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding?
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Primary Publication Information
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TitleData
Title Nonpharmacological management of headaches during pregnancy.
Author Marcus DA., Scharff L., Turk DC.
Country Department of Anesthesiology, University of Pittsburgh School of Medicine, Pennsylvania 15213, USA.
Year 1995
Numbers Pubmed ID: 8600478

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction form for Direct Evidence (Primary Studies)
Arms
Number Title Description Comments
1 Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation
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2 Complementary therapies: Thermal biofeedback
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Design Details
Question... Follow Up Answer Follow-up Answer
Which KEY QUESTION (KQ) does this study address? KQ2: Treatment of primary headache
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KQ2: Treatment of primary headache
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What is the STUDY DESIGN? Randomized controlled trial (RCT).....Skip to Question 5
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In what COUNTRY was the study done? US
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US
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What was the FUNDING SOURCE of the study? ... Non-industry, specify name(s) of agency... ... National Headache Foundation
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Does the study have a NAME or ACRONYM? No/not reported
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Does the study have a CLINICALTRIALS.GOV IDENTIFICATION NUMBER? No/not reported
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What were the START and END YEARS of the study? NR
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NR
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What were the study INCLUSION criteria? 1st or 2nd trimester; migraine headache, tension headache, or coexisting migraine and tension headache; minimum of 1 headache per week or 5 headaches per month
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What were the study EXCLUSION criteria? NR
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Do you have any NOTES regarding the design or any overall aspects of this study?
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Baseline Characteristics
Question Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
What was the SAMPLE SIZE at baseline? 11 14 25
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What were the RACE/ETHNICITY of the women in the study? Not reported Not reported Not reported
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What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 28.6 Mean 29.2 Not reported
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Standard deviation (SD) 6.3 Standard deviation (SD) 4.8
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What was the AGE DISTRIBUTION of the women in the study? (CATEGORICAL data) No data entered.
In what PHASE were the women in the study? 1st trimester...% NR 1st trimester...% NR Not reported...%
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2nd trimester...% NR 2nd trimester...% NR
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What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data) Mean 17.6 Mean 19.8 Not reported
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Standard deviation (SD) 4.9 Standard deviation (SD) 4.4
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What was the UNIT for the gestational age you answered in the previous question? Weeks Weeks
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What was the GRAVIDITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported
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What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data) Not reported Not reported Not reported
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What were the TYPES of PRIMARY HEADACHE in the women in the study? Migraine...% 27.3 Migraine...% 42.9 Not reported...%
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Tension headache...% 36.4 Tension headache...% 21.4
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Other...% Migraine headache and tension headache combined...36.4 Other...% Migraine headache and tension headache combined...35.7
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What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE? Not reported Not reported Not reported
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Do you have any NOTES regarding the baseline characteristics in this study? No data entered.



Results & Comparisons


Results Data
Outcome: Medication use      Population: All Participants
Time Point Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback


Baseline N/A

N Analyzed 11 14
Counts 4 10
Percentage 36.4 71.4


2 months

N Analyzed 11 14
Counts 3 6
Percentage 27.3 42.9
P-Value
Outcome: Acute headache attacks - Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback Comparison Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation vs. Complementary therapies: Thermal biofeedback


Baseline N/A

N Analyzed 11 14
Mean 2.0 2.5
SD 0.77 1.80


2 months

N Analyzed 11 14 <0.001
Mean 0.44 1.8
SD 0.70 2.0
Within-Arm Comparisons
Comparison Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback
2 months vs. Baseline N/A Mean % change -81.2 -32.7
SD % change 28.9 41.8
Outcome: Acute headache attacks - Severity      Population: All Participants
Time Point Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback


Baseline N/A

N Analyzed 11 14
Mean 7.8 7.8
SD 2.1 1.5


2 months

N Analyzed 11 14
Mean 2.3 5.7
SD 3.1 3.3
Outcome: Acute headache attacks - Severity      Population: All Participants
Time Point Measure Combination of Physical Therapy, Complementary Therapies: Thermal biofeedback, and Behavioral therapies: Relaxation Complementary therapies: Thermal biofeedback


Baseline N/A

N Analyzed 11 14
Mean 11.2 10.4
SD 3.7 3.9


2 months

N Analyzed 11 14
Mean 2.9 7.7
SD 4.3


Quality Dimensions
Dimension Value Notes Comments
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear NR
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear NR
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High Interventions were different
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High Interventions were different
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Unclear NR
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High Self-reported outcomes
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low All outcomes reported
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High >30% loss to followup
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? Yes
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.