Chen 2007.
Methods |
Design: randomised controlled trial, parallel design Setting: outpatients and hospitalised patients, single centre Country: Republic of China |
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Participants |
Sample size/available for analysis: 70/70 Gender: 30 females/40 males Age (years, mean and SD): 42.47 (± 14.07) years Duration of disease (months, mean and SD): 18.51 (± 8.43) months Inclusion criteria: "cervicogenic headache in accordance with the diagnostic criteria of Sjaastad; and at the same time one of the following conditions: course ≥ 6 months; nearly 3 months without any medication; cervical spine X‐ray inspection shows that the cervical spine has no degenerative changes." Exclusion criteria: "neurological diagnosis of other types of headache; cervical spine fracture, dislocation or discectomy and severe osteoporosis are not suitable for manipulation or nerve stimulation therapy." |
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Interventions |
Group 1: TENS (n = 34) Group 2: manipulation treatment (n = 36) Treatment duration: 4 weeks Follow‐up duration: 6 weeks Schemes of TENS: two 75 mm × 115 mm electrodes were placed in the upper cervical spine on both sides, symmetrical two‐way square wave output, frequency 100 Hz, pulse width 250 μs, 20 min each time during the course of treatment (10 sessions) |
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Outcomes |
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Notes |
Funding sources: not reported Conflict of interest: not reported Full text language: Chinese |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...with cervicogenic headache were randomly allocated to receive manipulation treatment and TENS treatment". Comment: information provided is not sufficient. |
Allocation concealment (selection bias) | Unclear risk | Quote: "...with cervicogenic headache were randomly allocated to receive manipulation treatment and TENS treatment". Comment: information provided is not sufficient. |
Blinding of participants | High risk | Comment: different interventions (TENS and manipulation therapy) were compared and blinding was not possible. |
Blinding of personnel/providers | High risk | Comment: due to the nature of the intervention, it was not possible to blind the physician who provided the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no available information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no losses of participants. |
ITT analysis | Low risk | No losses |
Selective reporting (reporting bias) | Unclear risk | Comment: the study protocol was not available. |
Group similarity at baseline | Low risk | Comment: the three groups seem to be similar at baseline. |
Cointerventions | Low risk | No cointerventions |
Compliance | Unclear risk | Comment: compliance with the intervention was not reported. |
Timing of outcome assessments | Low risk | Comment: timing of outcome assessment is identical for all intervention groups and for all primary outcome measures. |
Other bias | Low risk | Comment: no other biases were identified. |