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1.         Abstract
2.               Treatment
3.         Background
4.         Objectives
5.         Criteria for including studies
6.         Search strategy
7.         Data collection and evaluation of studies
8.         Description of studies
9.         Methodological quality
10.       Results
11.       Discussion of findings
12.       Conclusions
13.       References
 14.      Further Resources

1. Abstract
Headache is one of the most common medical complaints in the general population. Tension-type headache and migraine are the most common types of primary headache (headache that is not due to underlying disease). People with tension-type headache or migraine can experience considerable pain, disability and reduced quality of life

Many people with headache use non-invasive physical therapies, in addition to, or instead of, pharmacological treatments. There are a diverse range of physical therapies with various proposed modes of action. Some physical therapies are administered by health professionals while others are administered by practitioners of complementary medicine. Many physical therapies are self-administered.

There is some evidence from a Cochrane systematic review to suggest that certain physical therapies may be of some benefit in preventing migraine and tension-type headache. In particular, spinal manipulation may be of benefit, though it is not possible to make definitive conclusions.

The evidence to support various other physical therapies such as pulsating electromagnetic fields, transcutaneous electrical nerve stimulation (TENS), therapeutic touch, cranial electrotherapy and massage (or various combinations of these) is weak.

The studies in the Cochrane review were generally inadequately powered to evaluate safety. However, the limited evidence available suggests that non-invasive physical therapies are associated with little risk of serious adverse events.  

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2. Treatment
Type of treatment:
Non-invasive physical treatments for people with chronic or recurrent headache.

 Synonyms and Common names Treatments include (but are not limited to) therapeutic heat or cold, traction, electrical modalities (e.g. TENS, interferential therapy, electromagnetic therapy, microcurrent, ultrasound, laser), exercise, spinal manipulation or mobilisation, massage, reflexology, stretching and trigger-point therapy.

Indication Treatment of people with chronic or recurrent headache.

3. Background
Headache is among the most common medical complaints in the general population. Headaches are categorized as primary if there is no underlying medical condition to account for the headache, or secondary if the headache is due to an underlying medical condition.  

Tension-type headache is the most common primary headache and accounts for 90% of all headaches. Migraine is the second most frequently occurring primary headache (Steiner 2002). Tension-type headache and migraine can cause a significant amount of pain and disability, and can lead to a reduced quality of life. In addition, they are associated with a significant socioeconomic burden due to days of work lost. It should be noted that symptoms of migraine and tension-type headache often overlap and a diagnosis is sometimes difficult.

There are various treatment approaches for primary headaches. These commonly involve pharmacological therapy. Simple analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to relieve headache pain while more potent analgesics may sometimes be required. Various classes of medication are also used in a prophylactic capacity to prevent headaches in those with chronic or recurrent headache.

Many people use physical therapies in addition to (or instead of) pharmacological treatment to treat headache. There are many different types of physical treatments. Some of these include therapeutic heat or cold, traction, electrical modalities (e.g. TENS, interferential therapy, electromagnetic therapy, microcurrent, ultrasound, laser), exercise, spinal manipulation or mobilization, massage, reflexology, stretching and trigger-point therapy. Physical treatments are often used with the aim of avoiding the side effects of pharmacological treatment.

Some of these physical therapies are administered by health professionals such as physiotherapists or practitioners of complementary medicine, while others may be self-administered. For many physical treatments, the precise mode of action is poorly understood. Nevertheless, theories concerning their effects often relate to the observation that direct mechanical pressure and effects mediated by the nervous system may

reduce muscular and mental tension.

The aim of this review was to assess the effectiveness of non-invasive physical therapies in people with chronic or recurrent headache. A secondary objective was to evaluate the safety of these therapies.

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4. Objectives
To assess the potential benefits and harms of non-invasive physical therapies for people with chronic or recurrent headaches.

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5. Criteria for including studies

·        Types of study: published systematic reviews or randomised controlled trials (RCTs) and quasi-randomised trials of non-invasive physical treatments versus placebo, no treatment or any other treatment, in people with chronic or recurrent headache.

·        Types of participants: persons of any age with chronic or recurrent headache including (but not limited to) migraine, episodic and chronic tension-type headache, cluster headache and cervicogenic headache.

·        Types of intervention: non-invasive physical treatments including (but not limited) to therapeutic heat or cold, traction, electrical modalities (e.g. TENS, interferential therapy, electromagnetic therapy, microcurrent, ultrasound, laser), exercise, spinal manipulation or mobilization, massage, reflexology, stretching and trigger-point therapy.

·        Types of outcome measure: patient-related outcomes such as headache pain intensity, headache index, headache frequency, headache duration, analgesic use, activities of daily living, quality of life, functional health status or patient satisfaction. Side effects were reported, if data were available.  

·        Exclusions: Studies of acupuncture and psychological interventions as the primary intervention were excluded.

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6. Search strategy
The following databases were searched in May 2006: AMED, The Cochrane Library, MEDLINE, EMBASE, CINAHL. The reference lists of publications retrieved by the search for further relevant studies were checked.

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7. Data collection and evaluation of studies
We used the above search strategy to obtain titles and abstracts of studies that were potentially relevant to this review. Where studies met the criteria for inclusion, they were assessed in full text. The quality of each study was evaluated using the SIGN criteria (http://www.sign.ac.uk/methodology/checklists.html) for the evaluation of RCTs and systematic reviews. Where primary studies were included in a good quality systematic review, the systematic review was included rather than the individual primary studies.

The overall quality of the body of evidence (considering all the included studies) was graded according to the CEBM levels of evidence system (www.cebm.net/levels_of_evidence.asp).

 Relevant data were extracted from the studies selected for inclusion.

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8. Description of studies
Only a single Cochrane systematic review of randomised and quasi-randomised controlled trials of non-invasive physical treatments for chronic or recurrent headache (Bronfort et al. 2004) met the criteria for inclusion. Studies published since the Cochrane systematic review did not meet the criteria for inclusion.

Summary details of the trials included in the systematic review are as follows:

Study

Participants

Intervention & Comparison

Outcomes measured

Comment

Ahonen 1984

 

Finland

 

22 people with myogenic headache associated with tension-neck syndrome

Acupuncture

vs parafango (warm paraffin and mud) + massage followed by ultrasound

for 3 weeks

·     Headache pain intensity (VAS)

Parallel group design

Loss to follow up not specified

Side effects not specified

Ammer 1990

 

Austria

40 people with cervicogenic-like occipital headache

Spinal manipulative therapy + pulsed galvanic current to neck

vs direct galvanic current to forehead/neck + ultrasound and UV-light

vs moist herbal pack + massage of neck and shoulders

for 2 weeks

·      Patient-rated headache improvement

 

Parallel group design

16% loss to follow up (7/45)

Bitterli 1977

Switzerland

30 people with cervicogenic-like headache

Spinal manipulative therapy for 3 weeks

vs mobilization for 3 weeks

vs waiting for 3 weeks  followed by spinal manipulative therapy for 3 weeks,

with post-treatment follow up at 3 months

·      Headache pain intensity (VAS)

Parallel group design

23% (7/30) missing pain ratings at 3 months

Side effects not specified

Boline 1995

USA

150 people with tension-type headache

High velocity, low amplitude spinal manipulative therapy (preceded by moist heat and light massage to neck)

vs amitriptyline therapy

for 6 weeks

·      Headache pain intensity, headache frequency, and OTC medication use

Parallel group design

16% loss to follow up (24/150)

Side effects reported

Bove 1998

 

Denmark

75 people with tension-type headache

Soft tissue therapy (deep friction massage) and high velocity, low amplitude cervical spinal manipulative therapy

vs soft tissue therapy + low power (placebo) laser treatment

·      Headache pain intensity

·      Headache duration

·      Medication use

Parallel group design

7% loss to follow up (5/75)

 

Carlsson 1990

Sweden

48 people with tension-type headache

Relaxation, automassage, cryotherapy, TENS, stretching and education over 8-12 weeks

vs classical Chinese acupuncture over 2-8 weeks

·      Headache pain intensity

·      Headache frequency

 

16% loss to follow up (10/62)

Side effects reported

Howe
1993

UK

27 patients with neck-related, chronic, non-specified headache

NSAID + high velocity, low amplitude cervical spinal manipulative therapy

vs NSAID alone

·      Patient-rated degree of headache improvement

Parallel group design

Dosage and time not reported

Loss to follow up not specified

Side effects not reported

Hoyt
1979

22 people with chronic muscle tension headache

Palpatory examination of cervical spine + high velocity, low amplitude cervical manipulation + soft tissue procedures

vs palpatory examination of cervical spine without manipulation

vs supine rest

for 10 minutes

·      Headache pain intensity

Parallel group design

Loss to follow up not specified

No information about side effects

Location not specified

Jensen 1990

 

Denmark

23 people with post-traumatic headache

Manual therapy to cervical and upper thoracic spine often in combination with muscle energy technique

vs cold pack to neck and shoulders for 15-20 minutes

for 2 sessions (1 per week)

·      Headache pain intensity

Parallel group design

17% loss to follow up (4/23)

Side effects not specified

Jull
2002

 

Australia

200 people with cervicogenic headache

Manipulative therapy

vs therapeutic exercise

vs manipulative therapy + therapeutic exercise

vs no physical treatment

·      Headache pain intensity

·      Headache frequency

·      Headache duration

2х2 factorial design

3.5% loss to follow up (7/200)

Some information relating to side effects

Keller
1986

 

USA

60 people with tension headache

Therapeutic touch with intention to heal + rest and deep breathing

vs placebo touch without intention to heal + rest and deep breathing

for 1 session

·      Pain using 3 subscales from McGill-Melzack Pain Questionnaire assessed 5 minutes and 4 hours after treatment

Loss to follow up not specified

Side effects not specified

 

Marcus 1998

 

USA

88 people with migraine headache

Postural correction, cervical range-of-motion exercises, isometric neck strengthening exercises, self-mobilisation exercises, whole body stretching and conditioning, and ‘flare up’ management techniques such as heat, ice and trigger point treatment

vs progressive muscle relaxation, breathing exercises and thermal biofeedback training

·      Headache severity (used to calculated headache index score)

·      Medication use

22% loss to follow up (19/88)

Side effects not specified

Nelson 1998

USA

 

218 people with chronic migraine headache

High velocity, low amplitude cervical spine manipulation preceded by light massage +/- trigger point therapy

vs amitriptyline therapy

·      Headache index (calculated using pain intensity)

·      OTC medication use

26% loss to follow up (56/218)

Side effects reported

 

Nilsson 1997

Denmark

54 people with cervicogenic headache

High velocity, low amplitude spinal manipulation

vs deep friction massage + low level laser

for 6 sessions over 3 weeks

·      Headache pain intensity

·      Headache duration

·      Medication use

2% loss to follow up (1/54)

Side effects not reported

Parker 1980

Australia

85 people with migraine headache

Cervical spine manipulation + other spinal manipulation (all by chiropractors)

vs cervical spine manipulation + other manipulation techniques (all by doctors or physical therapists)

Up to 2 sessions per week for 2 months

·      Headache intensity

·      Headache frequency

·      Headache duration

·      Headache disability

4% loss to follow up (3/85)

Side effects not specified

Reich 1989

USA

703 people with vascular/migraine headache or muscle contraction headache

Relaxation

vs electrical modalities

vs biofeedback

vs combination of two of the above

·      Headache pain intensity

·      Headache duration

Loss to follow up not specified

Sherman 1998

USA

12 people with migraine

Pulsating electromagnetic field (PEMF) applied to medial thigh

vs placebo (inactive PEMF)

for 10 sessions (1 hour per day, 5 days per week)

·      Number of headaches per week

Double-blind crossover design

Data are presented for patients who received either treatment first as 5/6 patients declined to cross over

Sherman 1999

48 people with migraine

Pulsating electromagnetic field (PEMF) applied to medial thigh

vs placebo (inactive PEMF)

for 10 sessions (1 hour per day, 5 days per week)

·      Headache activity index (calculated from headache frequency, duration, intensity and medication use)

Parallel group design

Location not specified

13% loss to follow up (6/48)

Side effects not specified

Solomon 1985

USA

62 people with migraine headache, muscle-contraction headache or both

Cranial electrotherapy-perceived stimulus

vs cranial electrotherapy-subliminal stimulus

for one 15 minute session

·      Pain severity

·      Headache pain intensity improvement

6% loss to follow up (4/62)

No information about side effects

Solomon 1989

USA

112 people with muscle contraction headache

Cranial electrotherapy (CE)

vs placebo CE

·      Headache pain intensity

·      % of patients rating CE effective

Parallel group design

Placebo-controlled

11% loss to follow up (12/112) because of lack of headaches that could be evaluated

Side effects reported

Tuchin 2000

Australia

127 people with migraine headache 

High velocity, low amplitude spinal manipulative therapy  (up to 16 treatments)

vs detuned interferential therapy

·      Headache pain intensity

·      Headache duration

·      Headache frequency

·      Medication use

Parallel group design

Number of sessions of interferential therapy not specified

3% loss to follow up (4/127)

Side effects reported

Whittingham 1997

Australia

105 people with cervicogenic headache

Spinal manipulative therapy

vs placebo,

for 3 sessions per week for 3 weeks

·      Headache pain intensity

·      Headache disability from Neck Disability Index

·      Number of headache locations

3% loss to follow up (3/105)

Unexplained inconsistency between main outcomes and diary data

Effectiveness of blinding not adequately evaluated


9. Methodological quality
The Cochrane review (Bronfort et al. 2004) was of good quality. However, clinical heterogeneity of the trials in terms of headache type, patient characteristics, interventions, comparison therapies and outcome measures, prevented the pooling of results for meta-analysis. In addition, of the 22 studies with a total of 2628 patients (age 12 to 78 years) that met the inclusion criteria, 12 studies had questionable methodological quality.

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10. Results

Migraine headache

Spinal manipulation therapy
The systematic review identified three trials that evaluated spinal manipulation therapy in people with migraine (Nelson 1998; Parker 1980; Tuchin 2000). These trials were too dissimilar for their results to be pooled. There is evidence from a good quality study that spinal manipulation therapy is similar to amitriptyline (Nelson 1998). There is some evidence (without a high degree of reliability) that spinal manipulation therapy is superior to mobilization in people with migraine (Parker 1980).

Pulsating electromagnetic fields
The systematic review identified two trials that evaluated the effect of pulsating electromagnetic fields in people with migraine (Sherman 1998; Sherman 1999). These two trials were too dissimilar for their results to be pooled. There is some evidence (without a high degree of reliability) that treatment with pulsating electromagnetic fields is superior to placebo in people with migraine headache.

Physical treatment combinations
The systematic review identified two trials that evaluated physical treatment combinations in people with migraine (Marcus 1998; Reich 1989). The two trials were too dissimilar for their results to be pooled. There is limited evidence that a combination of home exercise, stretching, and heat/ice is inferior to biofeedback/relaxation (Marcus 1998). There is some evidence (without a high degree of reliability) that a combination of TENS and electrical neurotransmitter modulation is inferior to biofeedback and superior to relaxation (Reich 1989).

Tension-type headache

Spinal manipulation therapy
The systematic review identified two trials that evaluated spinal manipulation therapy in people with tension-type headache (Boline 1995; Hoyt 1979). The two studies were too dissimilar for their results to be pooled. There was moderate evidence that spinal manipulation therapy is generally inferior to amitriptyline during treatment but may be superior to amitriptyline post-treatment (Boline 1995). There is limited evidence to suggest that spinal manipulation therapy is superior to no treatment (Hoyt 1979).

Cranial electrotherapy
One trial evaluated cranial electrotherapy in people with tension-type headache (Solomon 1989). This trial found that cranial electrotherapy was superior to placebo. However, reliability was compromised due to uncertainly over the impact that group differences in important baseline characteristics had on the final outcomes. 

Therapeutic touch
The systematic review identified one trial that evaluated therapeutic touch in people with tension-type headache (Keller 1986). Large and statistically significant lower pain ratings were observed post-treatment in people receiving therapeutic touch compared with placebo.

Physical treatment combination
The systematic review identified four trials that evaluated physical treatment combinations in people with tension-type headache (Ahonen 1984; Bove 1998; Carlsson 1990; Reich 1989). The four studies were too dissimilar for their results to be pooled. There was some evidence (without a high degree of reliability) that a regimen of massage, ultrasound and hot packs was similar to acupuncture (Ahonen 1984). There was moderate evidence to show that spinal manipulation therapy plus massage was no more effective than massage alone (Bove 1998). There is limited evidence that a regimen of auto-massage, TENS and stretching is at least as effective as acupuncture (Carlsson 1990). There was some evidence (without a high degree of reliability) that a combination of TENS and electrical neurotransmitter modulation may be similar to biofeedback and to relaxation after 4 weeks of treatment (Reich 1989).

Cervicogenic headache

Spinal manipulation therapy
Five studies evaluated spinal manipulation therapy in people with cervicogenic headache (Bitterli 1977; Howe 1983; Jull 2002; Nilsson 1997; Whittingham 1997). The five studies were too dissimilar for their results to be pooled.

There is some evidence (without a high degree of reliability) that spinal manipulation therapy is at least as effective as mobilisation and to a wait-list control for pain reduction (Bitterli 1977). There is some evidence (without a high degree of reliability) that spinal manipulation therapy plus NSAIDs is at least as effective as NSAIDs alone (Howe 1983). There is moderate evidence that spinal manipulation therapy is superior to no treatment in reducing headache pain and frequency, but similar to no treatment for headache duration (Jull 2002). There is some evidence (without a high degree of reliability) that spinal manipulation therapy is similar to exercise for headache pain and frequency (Jull 2002). There is moderate evidence showing that spinal manipulation therapy is at least as effective as massage plus placebo laser treatment (Nilsson 1997). There is moderate evidence that spinal manipulation therapy is superior to placebo for pain, disability and number of headache sites (Whittingham 1997).

Massage
One trial evaluated the effect of massage in people with cervicogenic headache (Nilsson 1997). This trial found that massage plus placebo laser was inferior to spinal manipulation therapy for pain and headache hours.

Exercise therapy
One trial evaluated the effect of exercise therapy in people with cervicogenic headache (Jull 2002). This trial found that exercise was superior to no treatment in reducing headache pain and frequency at 1 week and 1 year after 6 weeks of treatment. Exercise was also at least as effective as manipulation.

Mobilisation
One trial evaluated mobilisation in people with cervicogenic headache (Bitterli 1977). This showed some evidence (without a high degree of reliability) that mobilisation is inferior to spinal manipulation after 3 weeks of treatment and similar to manipulation at 3 months. 

Physical treatment combinations
Two trials evaluated physical treatment combinations (Ammer 1990; Jull 2002). The two studies were too dissimilar for their results to be pooled. There is some evidence (without a high degree of reliability) that spinal mobilisation therapy plus galvanic current is superior to a combination of galvanic current, ultrasound and UV light, and to a combination of massage and moist herbal packs, for headache improvement after 2 weeks (Ammer 1990). There is moderate evidence that spinal manipulation therapy plus exercise is superior to no treatment (Jull 2002). There is some evidence (without a high degree of reliability) that spinal manipulation therapy plus exercise is generally similar to exercise alone for reducing headache pain and frequency (Jull 2002). There is some evidence (without a high degree of reliability) that spinal manipulation therapy plus exercise is similar to spinal manipulation therapy alone (Jull 2002).

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11. Discussion of findings
The evidence for different non-invasive physical therapies for the various types of headache rests on separate, generally small, individual trials. The clinical heterogeneity of the trials prevented statistical pooling of results for meta-analysis. Furthermore, complete-blinding for some of the treatments is inherently impossible or very difficult to achieve.

As such, while there is some evidence to suggest that certain types of physical therapy may be of benefit in some types of headache, it is impossible to make definitive conclusions. The best available evidence relates to the use of spinal manipulation therapy in people with migraine. In a good quality RCT in people with migraine, spinal manipulation therapy was an effective treatment option, with a short-term effect similar to that of amitriptyline, a commonly used, effective drug. Weaker evidence suggests that various other physical treatments may also be effective, but results from these trials are not reliable enough to make firm conclusions.

There was no consistent evidence in these studies of any serious adverse events associated with non-invasive physical therapies, but the trials were probably underpowered to adequately assess adverse events. The relative cost-effectiveness of these physical therapies is not known.

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12. Conclusion
There is level 3 evidence from a Cochrane review that some physical therapies may be effective in people with certain types of chronic or recurrent headache. The best evidence relates to the use of spinal manipulation therapy in people with migraine, although weaker evidence suggests that various other physical treatments may also be of benefit to people with a range of headache types. Overall, physical treatments for people with chronic or recurrent headache do not appear to be associated with serious adverse events. More trials are needed to establish a firmer basis for considering physical treatments as viable options to pharmacological therapy.

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13. References

Ahonen E, Hakumäki M, Mahlamäki S, Partanen J, Riekkinen P, Sivenius J. Acupuncture and physiotherapy in the treatment of myogenic headache patients: pain relief and EMG activity. In: Bonica JJ, Lindblom U, Iggo A editor(s). Advances in Pain Research and Therapy. Vol. 5, New York: Raven Press, 1983:571-6. 

Ahonen E, Hakumäki M, Mahlamäki S, Partanen J, Riekkinen P, Sivenius J. Effectiveness of acupuncture and physiotherapy on myogenic headache: a comparative study. Acupuncture & Electro-Therapeutics Research 1984;9(3):141-50.   

Ammer K, Rathkolb O. Physical therapy in occipital headaches [Physikalische Therapie bei Hinterhauptkopfschmerzen]. Manuelle Medizin 1990;28:65-8.

Bitterli J, Graf R, Robert F, Adler R, Mumenthaler M. Objective criteria for the evaluation of chiropractic treatment of spondylotic headache [Zur Objektivierung der manualtherapeutischen Beeinflussbarkeit des spondylogenen Kopfschmerzes]. Nervenarzt 1977;48(5):159-62.   

Boline PD, Kassak K, Bronfort G, Nelson C, Anderson AV. Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial. Journal of Manipulative & Physiological Therapeutics 1995;18(3):148-54. 

Bove G, Nilsson N. Spinal manipulation in the treatment of episodic tension-type headache: a randomized controlled trial. JAMA 1998;280(18):1576-9.

Carlsson J, Augustinsson LE, Blomstrand C, Sullivan M. Health status in patients with tension headache treated with acupuncture or physiotherapy. Headache 1990;30(9):593-9. 

Carlsson J, Fahlcrantz A, Augustinsson LE. Muscle tenderness in tension headache treated with acupuncture or physiotherapy. Cephalalgia 1990;10(3):131-41.

Carlsson J, Rosenhall U. Oculomotor disturbances in patients with tension headache treated with acupuncture or physiotherapy. Cephalalgia 1990;10(3):123-9.

Carlsson J, Wedel A, Carlsson GE, Blomstrand C. Tension headache and signs and symptoms of craniomandibular disorders treated with acupuncture or physiotherapy. The Pain Clinic 1990;3(4):229-38.

Howe DH, Newcombe RG, Wade MT. Manipulation of the cervical spine--a pilot study. Journal of the Royal College of General Practitioners 1983;33(254):574-9.

Hoyt WH, Shaffer F, Bard DA, Benesler JS, Blankenhorn GD, Gray JH, et al. Osteopathic manipulation in the treatment of muscle-contraction headache. Journal of the American Osteopathic Association 1979;78(5):322-5.

Jensen OK, Nielsen FF, Vosmar L. An open study comparing manual therapy with the use of cold packs in the treatment of post-traumatic headache. Cephalalgia 1990;10(5):241