Introduction
Methods
Cervicogenic Headache International Study Group [3] | ||
Major criteriaa | 1. | Symptoms and signs of neck involvement |
a. Precipitation of head pain, similar to the usually occurring one: | ||
i. By neck movement and/or sustained awkward head positioning, and/or: | ||
ii. By external pressure over the upper cervical or occipital region on the symptomatic side | ||
b. Restriction of range of motion (ROM) in the neck | ||
c. Ipsilateral neck, shoulder, or arm pain of a rather vague nonradicular nature or, occasionally, arm pain of a radicular nature. | ||
2. | Confirmatory evidence by diagnostic anesthetic blockade | |
3. | Unilaterality of the head pain, without side shift | |
Head pain characteristics | 4. | a. Moderate-severe, non-throbbing, and non-lancinating pain, usually starting in the neck. |
b. Episodes of varying duration | ||
c. Fluctuating, continuous pain | ||
Other characteristics of some importance | 5. | a. Only marginal effect or lack of effect of indomethacin |
b. Only marginal effect or lack of effect of ergotamine and sumatriptan | ||
c. Female sex | ||
d. Not infrequent occurrence of head or indirect neck trauma by history, usually of more than only medium trauma | ||
Other features of lesser importance | 6. | a. Nausea |
b. Phonophobia and photophobia | ||
c. Dizziness | ||
d. Ipsilateral “blurred vision” | ||
e. Difficulties swallowing | ||
f. Ipsilateral edema, mostly in the periocular area | ||
International Classification of Headache Disorders-II [5] | ||
A. Pain, referred from a source in the neck and perceived in one or more regions of the head and/or face, fulfilling criteria C and D | ||
B. Clinical, laboratory and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck known to be, or generally accepted as, a valid cause of headache | ||
C. Evidence that the pain can be attributed to the neck disorder or lesion based on at least one of the following: | ||
i. Demonstration of clinical signs that implicate a source of pain in the neck | ||
ii. Abolition of headache following diagnostic blockade of a cervical structure or its nerve supply using placebo- or other adequate controls | ||
D. Pain resolves within 3 months after successful treatment of the causative disorder or lesion |
1. Study population (30 points) |
a) Description of inclusion and exclusion criteria (1 point). Restriction to a homogeneous study population (1 point) |
b) Comparability of relevant baseline characteristics: duration of complaint (1 point), value of outcome measures (1 point), age (1 point), recurrences (1 point), and radiating complaints/associated symptoms (1 point) |
c) Description of the randomization procedure (2 points). Randomization procedure which excluded bias, i.e. random numbers table (2 points) |
d) Description of dropouts for each group and their reasons (3 points) |
e) Loss to follow-up: less than 20 % loss to follow-up (2 points), OR less than 10 % loss to follow-up (4 points) |
f) Sample size: greater than 50 subjects in the smallest group after randomization (6 points), OR greater than 100 subjects in the smallest group after randomization (12 points) |
2. Interventions (30 points) |
g) Correct description of the manual intervention (5 points). All interventions described (5 points) |
h) Pragmatic study: comparison with an existing treatment modality (5 points) |
i) Co-interventions avoided in the design of the study (5 points) |
j) Comparison with a placebo control group (5 points) |
k) Mention of the experience of the therapist (5 points) |
3. Measurement of effect (30 points) |
l) Placebo controlled studies: patients blinded (3 points), blinding evaluated and fully successful (2 points) OR Pragmatic studies: patients fully naive, evaluated and fully successful (3 points), time restriction of no manual treatments for at least 1 year (2 points) |
m) Outcome measures: pain assessment (2 points), global measure of improvement (2 points), functional status (2 points), spinal mobility (2 points), medical consumption (2 points) |
n) Each blinded outcome measure mentioned under item M earns 2 points |
o) Analysis of post-treatment data (3 points), inclusion of a follow-up period longer than 6 months (2 points) |
4. Data presentation and analysis (10 points) |
p) Intention-to-treat analysis when loss to follow-up is less than 10 % OR intention-to-treat analysis as well as worst-case analysis for missing values when loss to follow-up is greater than 10 % (5 points) |
q) Corrected presentation of the data: mean or median with a standard deviation or percentiles for continuous variables (5 points) |
Results
Methodological quality of the RCTs
Study | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Piekartz and Lüdtke [30] | 2 | 3 | 4 | 3 | 2 | 0 | 10 | 5 | 0 | 0 | 5 | 2 | 6 | 6 | 3 | 0 | 5 | 56 |
Nilsson [24] | 2 | 2 | 4 | 3 | 4 | 0 | 10 | 5 | 5 | 0 | 0 | 2 | 4 | 4 | 3 | 0 | 5 | 53 |
Nilsson et al. [25] | 2 | 2 | 4 | 3 | 4 | 0 | 10 | 5 | 5 | 0 | 0 | 2 | 4 | 4 | 3 | 0 | 5 | 53 |
Jull et al. [26] | 2 | 5 | 4 | 3 | 4 | 0 | 10 | 5 | 5 | 5 | 5 | 2 | 8 | 8 | 5 | 5 | 5 | 81 |
Haas et al. [27] | 2 | 4 | 4 | 3 | 4 | 0 | 10 | 5 | 0 | 0 | 5 | 2 | 6 | 0 | 3 | 5 | 5 | 58 |
Borusiak et al. [28] | 2 | 2 | 4 | 0 | 4 | 0 | 10 | 0 | 5 | 5 | 5 | 2 | 6 | 0 | 0 | 0 | 5 | 50 |
Haas et al. [29] | 2 | 4 | 4 | 3 | 4 | 0 | 10 | 5 | 0 | 5 | 5 | 2 | 6 | 0 | 3 | 5 | 5 | 63 |
Randomized controlled trials (RCT)
Country | Study population | Method | Intervention | Results |
---|---|---|---|---|
Physiotherapy
| ||||
The Netherland [30] | 43 participants (16M, 27F) Age 18–65 years Mean age 36 years CEH mean duration >6 months and at least one of four signs of temporomandibular disorder (TMD) CEH diagnosed by neurologist | RCT of 7–7½ months duration conducted by a physiotherapist, i.e. Baseline evaluation 3- to 6-week treatment 6-month follow-up Comparison of baseline, post-treatment and at 6-month follow-up | Six interventions ≤30-min within 3–6 weeks The physiotherapist selected the technique and treatment and exercise he or she considered to be beneficial for the participant The experimental group received accessory (translatory) movements of temporomadibular region and/or masticatory muscle techniques such as trigger point treatment and muscle stretching. Active and passive movement facilitating optimal function of cranial nerve tissue, coordination exercises and home exercises. The therapist could also opt for additionally neuromusculoskeletal treatments for cervical region (n = 20) (7M, 13F) Conventional physiotherapy including manual techniques at the cranio-cervical region and exercises (n = 18) (6M, 12F) Drop outs (n = 5) | The experimental group showed a significant reduction in headache intensity 3- and 6-month post-treatment as compared to conventional physiotherapy (p < 0.001) The pain intensity was seven on a colored analog scale (comparable to VAS) at baseline and reduced to 3.2 and 2.1 at 3- and 6-month post-treatment in the experimental group, while the pain was stable around 6.8 in the conventional physiotherapy group at the three recordings |
Spinal manipulative therapy (SMT)
| ||||
Denmark [24] | 39 participants (17M, 22F) Age 20–57 years Mean 39 years Headache ≥5 days per month for at least 3 months CEH diagnosed by a physician and chiropractor | RCT of 6-week duration conducted by a chiropractor, i.e. 2-week baseline 3-week treatment 1-week follow-up Comparison of pre-treatment at week 2 and post-treatment at week 6 Headache diary | Cervical SMT by chiropractor i.e. toggle recoil at upper cervical and diversified technique at lower cervical determined by the chiropractor (n = 20) (9M, 11F) Soft tissue (ST) work including deep friction massage at cervico-thoracic area and laser therapy at upper cervical region (n = 18) (8M, 10F) Drop outs (n = 1) | Mean headache duration was reduced in both the CSMT and ST group (p < 0.0001 and p < 0.002, respectively), i.e. a 59 and 52 % reduction from pre- to post-treatment. Mean headache duration reduction was not statistically significant in the two groups Mean headache intensity was reduced in the cervical SMT group (p < 0.001), but not in ST group, i.e. a 36 and 22 % reduction from pre- to post-treatment Mean headache intensity reduction was not statistically significant in the two groups |
Denmark [25] | 54 participants (23M, 31F) Age 20–60 years Mean 37 years Headache ≥5 days per month for at least 3 months CEH diagnosed by physician and chiropractor | RCT of 5-week duration conducted by a chiropractor, i.e. 1-week baseline 3-week treatment 1-week follow-up Comparison of pre-treatmen at week 1 and post-treatment at week 5 Headache diary | Cervical SMT by chiropractor i.e. toggle recoil at upper cervical and diversified technique at lower cervical determined by the chiropractor (n = 28) (13M, 15F) Soft tissue (ST) work including deep friction massage at cervico-thoracic area and laser therapy at upper cervical region (n = 25) (10M, 15F) Drop outs (n = 1) | Median headache duration was reduced in both cervical SMT and ST group (p < 0.0001 and p < 0.04, respectively), i.e. a 69 and 37 % reduction from pre- to post-treatment Median headache duration was reduced more in the cervical SMT than in the ST group (p < 0.03) Median headache intensity was reduced in the cervical SMT group (p < 0.0015), but not in ST group, i.e. a 36 and 17 % reduction from pre- to post-treatment. Median headache intensity was reduced more in the cervical SMT than in the ST group (p < 0.04) |
Australia [26] | 200 participants (60M, 140F) Age 18–60 years Mean 36.7 years Mean headache duration 6.1 years CEH diagnosed by GPs or physiotherapists | RCT of 12-month duration conducted by physiotherapists i.e. 2-week baseline 6-week treatment 3-, 6- and 12-month follow-up Comparison of baseline, immediately following post-treatment and 12-month follow-up Headache diary recording | Cervico-scapular muscle exercise twice a day (n = 52) (9M, 43F) Cervical SMT a total of 8-12 treatments ≤30-min (n = 51) (19M, 32F) Combined cervical SMT and cervico-scapular muscle exercise (n = 49) (21M, 28F) Control group (no treatment) (n = 48) (11M, 37F) Drop outs (n = 7) | Headache frequency and intensity were reduced immediately following post-treatment and at 12-month follow-up in all intervention groups as compared to the control group (p < 0.001–0.05) A 50 % reduction in headache frequency was noted in 76 % in cervico-scapular muscle excercise group, 71 %, in the cervical SMT group, 81 % in the combined cervical SMT and exercise group and 29 % of the control group, while 100 % reduction was observed in 31, 33, 42 and 4 % of the four groups Headache duration was reduced in the cervical SMT and the combined cervical SMT and exercise group immediately following post-treatment (p < 0.05 and 0.001 respectively) and in the combined cervical SMT and exercise group at 12-month follow-up (p < 0.05) |
USA [27] | 24 participants (4M, 19F, 1 unknown) Mean age 40.3 years Mean headache duration >3 months CEH diagnosed by chiropractor | RCT of 12-week duration conducted by three chiropractors, i.e. baseline evaluation 3-week treatment Follow-up at weeks 4 and 12 Comparison of baseline, 4 (1 week post-treatment) and 12-week follow-up Headache diary recording | All participants received cervical SMT by the diversified technique, with an option for additional two physical modalities, i.e. heat and soft tissue therapy including massage and trigger point therapy. Treating chiropractor could also recommend modifications of daily activities and rehabilitative exercises SMT 1 time per week (n = 7) (2M, 5F) SMT 3 times per week (n = 8) (2M, 8F) SMT 4 times per week (n = 8) (8F) Drop outs (n = 1) | At 4-week follow-up headache intensity (see result text for details) was significantly reduced in SMT 4 times a week group as compared to SMT one time a week group, and at 12-week follow-up headache intensity was significantly reduced in both the SMT 3 and 4 times a week groups as compared to the SMT 1 time a week group At 4- and 12-week follow-up the mean headache intensity was reduced 21 and 4 % in the SMT 1 time a week group, 49 and 44 % in the SMT 3 times a week group and 58 and 38 % in the SMT 4 times a week group At 4- and 12-week follow-up the mean headache frequency improved 41, 45, 61 %, and 14, 36, 53 % in the SMT 1, 3 and 4 groups, respectively |
Germany [28] | 52 participants (21M, 31F) Age 7–15 years Mean age 11.6 years At least headache once a week for at least 6 months CEH diagnosed by physician | Prospective RCT of 4-month duration conducted by a physician, i.e. 2-month baseline One treatment 2-month follow-up Comparison of baseline, post-treatment, follow-up Headache diary recording | Cervical SMT by physician (n = 24) Sham cervical manipulation (Placebo) (n = 28) Drop outs (n = 4) | Both the treatment and sham group had a statistically significant reduction in headache days from baseline to 2-month follow-up (p = 0.009 and p = 0.027), i.e. from 40.4 to 30.7 % days with headache, and from 41.2 to 31.8 % days with headache Headache frequency, total duration and intensity showed no statistical significant change in neither of the two groups No statistically significant differences were found between the two group in relation to the headache variables described above |
USA [29] | 80 participants (16M, 64F) Mean age 36 years Mean headache duration >3 months CEH diagnosed by chiropractor | Prospective RCT of 6-month duration conducted by four chiropractors, i.e. Baseline evaluation 8-week treatment Follow-up at weeks 12 and 24 Comparison of baseline, 12- and 24-week follow-up Headache diary recording | All interventions received 10 min visits by chiropractors One cervical and upper thoracic SMT treatment every week, with prior optional 5 min moist heat pack and 2 min light massage and 8 visit including control physical examinations but no treatment (n = 20) (4M, 16F) Two cervical and upper thoracic SMT every week, with prior optional 5 min moist heat pack and 2 min light massage (n = 20) (4M, 16F) One 5 min of moist heat followed by 5 min light massage every week and eight control physical examination but no treatment (n = 20) (5M, 15F) Two 5 min of moist heat followed by 5 min light massage every week (n = 20) (3M, 17F) Drop outs (n = 7) | Headache intensity at 4, 12 and 24 weeks improved more in the SMT group than in light massage group that received treatment twice a week (p < 0.05), while a similar comparison among those whom received treatment once a week was not statistical significant At 24 weeks mean headache intensity was reduced 35 and 45 % in the SMT groups treated once or twice a week, while it was reduced 27 and 17 % in the similar light massage groups At 24 weeks a 50 % reduction in pain intensity was achieved by 28 and 47 % in the SMT groups treated once or twice a week, while it was 28 and 16 % in the similar light massage groups At 24 weeks mean headache frequency was reduced 48 and 56 % in the SMT groups treated once or twice a week, while it was reduced 35 and 31 % in the similar light massage groups |