Clinical Effectiveness of Laser Acupuncture: A Systematic Review

Article Outline

• Abstract
• 1.. Introduction
• 2.. Methods
• 3.. Selection Criteria
  • 3.1.. Types of study
  • 3.2.. Types of participants
  • 3.3.. Types of intervention
  • 3.4.. Types of outcome
  • 3.5.. Search strategy and selection of studies
  • 3.6.. Assessment of methodological quality
  • 3.7.. Data extraction and analysis
    • 3.7.1.. Nature of disorder
    • 3.7.2.. Control group
    • 3.7.3.. Outcome measures
    • 3.7.4.. Follow up
    • 3.7.5.. Outcomes
    • 3.7.6.. Levels of evidence
  • 3.8.. Adequacy of treatment/clinical appropriateness
• 4.. Results
  • 4.1.. Study selection
  • 4.2.. Study quality (Table 1)
  • 4.3.. Study characteristics
  • 4.4.. Outcome measures
  • 4.5.. Clinical appropriateness of laser acupuncture treatments
  • 4.6.. Clinical effectiveness of laser acupuncture: musculoskeletal pain (see Table 2)
    • 4.6.1.. Myofascial pain/musculoskeletal trigger points
    • 4.6.2.. Lateral epicondylitis (Tennis elbow)
  • 4.7.. Clinical effectiveness of laser acupuncture: other conditions (see Table 3)
    • 4.7.1.. Post-operative nausea and vomiting
    • 4.7.2.. Smoking cessation
    • 4.7.3.. Nocturnal enuresis
    • 4.7.4.. Interstitial cystitis
    • 4.7.5.. Headache
• 5.. Discussion
• 6.. Summary and Implications for Future Research
• References
• Copyright

Abstract 

The use of laser light as an alternative to needles to stimulate acupuncture points has been promoted for almost three decades. However, there has been no systematic assessment of the evidence to support the effectiveness of this form of acupuncture to date. A systematic review was therefore undertaken of RCTs evaluating laser acupuncture as a primary intervention. Relevant studies (n = 18) were identified using computer-based literature searches and selected hand searches. Evidence was found to support the use of laser acupuncture in the treatment of myofascial pain, postoperative nausea and vomiting and for the relief of chronic tension headache. Laser acupuncture would appear to represent an effective form of acupuncture for the management of these conditions and could be considered as a viable alternative to more traditional forms of acupuncture point stimulation.

Key words:  acupuncture , laser , review systematic

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1. Introduction 

Low intensity laser therapy (LILT) is a form of phototherapy which has been employed as a treatment for a variety of conditions, including musculoskeletal and soft tissue injuries and chronic ulceration [1, 2, 3, 4, 5, 6]. Such lasers have also been recommended as an effective alternative to metal needles for the stimulation of acupuncture or musculoskeletal trigger points; this form of therapy is commonly termed “Laser Acupuncture” to distinguish it from the wider therapeutic applications of such laser devices [7, 8]. Laser acupuncture is promoted as inherently safer than needle acupuncture due to the non-invasive nature of treatment (e.g., in cases of HIV infection) and as a method which is more appropriate for the stimulation of difficult points such as auricular acupuncture points (e.g., for smoking cessation) or points around the perineum or genitals (e.g., for sexual dysfunction) [7].

Despite a long history of laser acupuncture as a therapeutic approach [9] and its apparent popularity, there has been no systematic approach to the development of research in this area. Furthermore, the lack of an obvious mechanism of action (particularly given lack of any sensation during laser treatment), coupled with inconsistent reports of clinical effectiveness, has resulted in skepticism [10].

To date, there have been no systematic reviews of the evidence in this area; the current study was therefore undertaken with the aim of determining the evidence base for the clinical effectiveness of laser acupuncture. Specific objectives for this systematic review were:

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2. Methods 

A systematic review was undertaken of the evidence to support the clinical effectiveness of laser acupuncture from Randomized Controlled Trials (RCTs) in keeping with good practice guidelines produced by the World Association for Laser Therapy (WALT) [11].

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3. Selection Criteria 

3.1. Types of study 

Only RCTs published in the English language were included in this review; studies employing a randomized cross over design were excluded, as this was considered an inappropriate design for the assessment of effectiveness of laser acupuncture.

3.2. Types of participants 

Studies based upon treatment of adults (> 18 years) with soft tissue injury, an acute or chronic pain condition or any systemic illness were included.

3.3. Types of intervention 

Articles evaluating laser acupuncture as the primary intervention were included. Laser acupuncture was defined as the application of low intensity laser radiation (i.e., non-thermal intensities) to classical meridian points or trigger points. Studies in which the primary treatment involved needling, acupressure, Sham laser acupuncture or non-acupuncture application of low intensity laser therapy were excluded. Acceptable control interventions were: no treatment, placebo or sham laser, other sham procedure, or other therapeutic intervention.

3.4. Types of outcome 

RCTs were included that used at least one of the following outcomes: pain intensity (visual analogue scale; VAS), or a global measure of patient improvement (overall improvement, proportion of patients recovered, subjective improvement of symptoms). For those trials including subjects with non-painful illnesses, the primary outcome measure was considered for its appropriateness to the presenting condition.

3.5. Search strategy and selection of studies 

Relevant studies were identified with a computer-based literature search using seven key words/phrases (laser, laser therapy, laser acupuncture, LLLT, pain, soft tissue, injury) on the following databases on OVID: Sports discus (1960-2005), Medline (1966-September 2005), EMBASE (1980-September 2005), CINAHL (1982-September 2005), British Nursing Index (1985-September 2005), AMED (1985-September 2005). In addition, a series of 31 small searches were performed on PubMed (1966-September 2005), by combining 13 key words (low level laser, laser acupuncture, LLLT acupuncture, laser, LLLT, laser therapy, injury, pain, soft tissue, strain, sprain, musculoskeletal, rheumatic) using Boolean logic (AND).

More limited searches were undertaken on the Physiotherapy Evidence Database (PEDro; 1966-April 2005) and Acubriefs (www.acubriefs.com) using one key word (laser). This was supplemented with a related articles search on PubMed and citation tracking of relevant primary and review articles (n = 35), and all incoming full text papers (n = 134). In addition a convenience search of one key journal was performed (Laser Surgery Medicine 1994-2005).

In the first stage of selection, titles and abstracts of all studies were assessed for the above eligibility criteria. If it was clear from information provided in the title and/or abstract that the study was not relevant it was excluded; if it was unclear from the available abstract and/or title, the full text article was retrieved. Full text articles were also retrieved for studies with a relevant title, but no available online abstract. There was no blinding to study author, place of publication or results. One author (CB) assessed the content of all full text articles, making the final inclusion/exclusion decisions.

3.6. Assessment of methodological quality 

Methodological quality of each RCT was independently assessed by two authors (CB, SMcD). Review authors were not blinded with respect to authors, institution or journal. Consensus was used to resolve disagreements and the third author was consulted if disagreements persisted (GDB). The methodological quality of the RCTs was assessed by using the van Tulder scale [12]. Each item was scored ‘yes’, ‘no’ or ‘don't know’ according to the definitions of the criteria (see Table 1).

Table 1. Summary of quality ratings: van Tulder scores

Higher quality studies (≥ 6) represented in bold.

Key: van Tulder Internal Validity Criteria

A. Was the method of randomization adequate?

B. Was the treatment allocation concealed?

C. Were the groups similar at baseline regarding the most important prognostic indicators?

D. Was the patient blinded to the intervention?

E. Was the care provider blinded to the intervention?

F. Was the outcome assessor blinded to the intervention?

G. Were co-interventions avoided or similar?

H. Was the compliance acceptable in all groups?

I. Was the dropout rate described and acceptable?

J. Was the timing of the outcome assessment in all groups similar?

K. Did the analysis include an intention to treat analysis?

Studies were classified into low or high quality: high quality was defined as a trial fulfilling six or more of the 11 methodological criteria; and this classification was used to grade the strength of the evidence.

3.7. Data extraction and analysis 

One author (CB) extracted data on the study characteristics: study population, interventions, analyses and outcome. Studies were first assessed for clinical homogeneity with respect to the nature of the disorder, control group and the type and timing of outcomes. Studies were divided and analyzed as follows:

The primary focus of this review was musculoskeletal pain; this included myofascial pain and soft tissue injuries (including laser applied to trigger points, as well as to traditional acupuncture points). In addition, relevant papers detailing laser acupuncture treatment of other conditions were included as a secondary focus for the current review.

Acceptable control or comparison groups included: no treatment, placebo/sham laser acupuncture; needle acupuncture; acupressure; other interventions not including laser treatment.

Acceptable outcome measures included: pain, global function or (for ‘other conditions’) a relevant primary outcome measure.

Relevant details on any follow ups were noted.

Means and standard deviations for outcome measures were extracted and (where possible) individual study-effect estimates were calculated using RevMan software. This took the form of standardized mean differences (SMD) for continuous data [13] or risk ratios (RR) for dichotomous data, each with 95% confidence intervals (95% CI) [14]. When effect size could not be calculated (for example: no information about standard deviation was provided) a qualitative analysis was performed.

In addition, for the purposes of interpretation of results, the following levels of evidence were used [12, 15]:

3.8. Adequacy of treatment/clinical appropriateness 

Two authors (GDB, CB) independently extracted the following details concerning the laser dosage parameters: wavelength, area of treatment, power, dosage per treatment point (where necessary derived from time of application) and, where possible, total dosage. The accuracy and clinical appropriateness of the treatment dose was assessed by one author who has researched and published widely in the area of laser therapy (GDB), using the recommendations of the WALT as a guideline (www.walt.nu) [16]. The adequacy of the choice of acupuncture point, relative to each condition, was assessed by an experienced acupuncturist (SMcD) based upon established guidelines [17].

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4. Results 

4.1. Study selection 

Figure shows the Quality of Reporting of Meta-Analysis (QUOROM) statement flow diagram [18] summarizing the process of study selection and the number and reason for exclusion of studies at each stage. From the initial examination of citations yielded through the literature search, 133 studies were included. After review of the complete texts, 115 studies were excluded, leaving 18 eligible randomized controlled trials for inclusion in the current review; of these trials, of which 12 investigated the effectiveness of laser acupuncture in relieving pain.

4.2. Study quality (Table 1) 

There were five ‘high quality’ studies in the included trials [19, 20, 21, 22, 23]; the remaining thirteen studies scored less than 6/11 on the van Tulder scale and were categorized as ‘low quality’. There were several criteria which consistently limited the quality of studies: none of the included 18 studies carried out allocation concealment or intention-to-treat analysis adequately; only three [23, 24, 25] were considered to have performed a sufficient randomization procedure.

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• Figure. 

  QUOROM flow diagram.

4.3. Study characteristics 

Study characteristics are summarized in Table 2, Table 3.

Table 2. Summary of study characteristics: laser acupuncture for painful conditions

Table 3. Summary of study characteristics: laser acupuncture for other conditions

4.4. Outcome measures 

Four studies [21, 26, 27, 28] failed to provide sufficient data for any of the key outcome measures and it was not possible to calculate individual study effect estimates (either SMD or RR).

4.5. Clinical appropriateness of laser acupuncture treatments 

Assessment of the clinical appropriateness of treatments employed within the reviewed trials was confounded by the lack of detail in some published papers. Beyond this, it is noteworthy that those studies reporting negative results (no significant benefit of laser acupuncture compared with control or sham conditions) were all associated with lack of detail on treatments employed or the use of inappropriate treatment parameters, including insufficient laser power outputs or dosages (for detail see Table 2, Table 3).

4.6. Clinical effectiveness of laser acupuncture: musculoskeletal pain (see Table 2) 

The effectiveness of laser acupuncture in the treatment of myofascial pain or musculoskeletal trigger points affecting the neck, shoulder, thoracic or lumbar spine was investigated in the majority of studies reviewed (n = 9); seven of these reported positive outcomes in favor of laser acupuncture [19, 20, 21, 28, 29, 30, 31]. The number of treatment sessions in the studies ranged from 10 to 12 and all incorporated at least one measurement of pain at the end of the treatment period. The majority of studies also included some form of follow up assessment, although the longest period for such review was only 3 months. Irradiation parameters used in these studies varied markedly: power outputs ranged from 0.95 mW to 25 mW and doses from 0.57 J to 5 J per point. In the two studies which reported negative results (no significant differences between active and placebo irradiation) [32], it was not possible to determine the actual laser irradiation parameters used by researchers. However, it was estimated that both of these groups failed to employ appropriate power outputs and dosages per point: for Waylonis et al [25] dosage was estimated at < 0.075 J point and in the case of Altan et al [32], the clinical appropriateness of dosages employed by this research group have been challenged previously [33].

It was therefore concluded that there is moderate evidence that laser acupuncture, is effective at reducing myofascial pain—at least when applied at certain irradiation parameters.

Haker and colleagues completed three early placebo-controlled studies on the potential effectiveness of laser acupuncture in lateral epicondylitis (tennis elbow) [20, 21, 34], the latter two of which were rated as ‘high quality’ [21, 22]. The first of these studies used a combination of laser systems (632.4 nm and 904nm; 0.042 J and 0.0936 J, respectively) to 10 points and failed to find any clinical benefits at the end of the treatment period in any of the outcome measures used (including VAS for pain) [34]. This group also monitored nerve conduction in treated subjects and found a small but significant increase in latencies 15 minutes after irradiation, which they attributed to immobilization of the subjects’ limbs during the investigation. However, this finding of increased latencies has been reported by other groups investigating the physiological effects of laser irradiation in healthy human volunteers [35, 36, 37]. In the second study by this group, laser was applied to five acupuncture points using a 904 nm infrared system to deliver a higher dose of 0.36 J per point [20]. After 10 treatment sessions, there were no significant differences between groups in terms of pain (RR 3.09; 0.88 to 10.38); in addition, no significant differences were reported at follow ups recorded at 3 months (RR 0.9; 0.29 to 2.85) and 1 year (RR 1.63; 0.36 to 7.33). Furthermore, no significant changes were seen between groups in terms of the functional outcome measure used (grip strength). In a further study by this group [21], a combination of visible and infrared laser in a multisource array unit was used to treat the tender area of the elbow, in addition to a pen probe laser applied to two acupuncture points (LI11, 12). This treatment combination again failed to show any improvement in terms of pain or function when compared with the placebo group after a series of 10 treatments (RR 0.55; 0.15 to 1.93) and at 3 months follow up (RR 0.85; 0.28 to 2.52).

None of these studies demonstrated any significant effect of laser acupuncture compared with placebo, which would suggest no benefit from laser acupuncture in the treatment of this condition. However, and notwithstanding the high methodological quality of two of these studies, the combinations of irradiation parameters used by these investigators were considered to be inadequate to provide any clinical benefit: power outputs ranged from 0.7–12 mW, while dosages per point ranged from 0.0936–0.6 J. Beyond this, this group typically used non-contact treatment (with the laser held 1 mm from the target tissue) which was also considered inappropriate as it would limit penetration of light into the tissue. There was therefore insufficient evidence upon which to make a decision as to the effectiveness of laser acupuncture in the treatment of lateral epicondylitis.

4.7. Clinical effectiveness of laser acupuncture: other conditions (see Table 3) 

One low quality [38] and one high quality RCT [22] studied the effectiveness of laser acupuncture in comparison to placebo in reducing post-surgical nausea and vomiting in children. Both studies applied laser to the P6 acupuncture point. Schlager et al [22] found that a dose of 0.3 J point applied bilaterally 15 minutes prior to, and repeated 15 minutes after, surgery was significantly more effective than placebo at reducing the incidence of vomiting (RR. 0.06; 0.01–0.29). In a similar study, Butkovic et al [38] found that a dose of 1 J applied 15 minutes before surgery significantly reduced the incidence of nausea and vomiting during the first 2 hours post-operatively, when compared with placebo laser (RR 0.21; 0.07–0.66). It was therefore concluded that there is moderate evidence that the use of laser acupuncture is more effective than placebo in reducing post-operative nausea and vomiting.

A single high quality study by Yiming [19], using a follow up time of 3 months, found that 12 sessions of laser acupuncture to five auricular acupuncture points made no difference to the smoking habits of a group of adolescent smokers, when compared with those receiving placebo treatment (RR. 1.03; 0.57–1.84). The laser parameters used in this study were not specified, and therefore it was not possible to estimate the actual dosage employed. There was therefore insufficient evidence upon which to make a decision as to the effectiveness of laser acupuncture in smoking cessation.

Radmayr et al [39] compared the effectiveness of laser acupuncture to medication intervention in preventing nocturnal enuresis. Both groups had a significant reduction in bedwetting and although comparison between groups slightly favored the desmopressin group (RR: 1.62; 0.41–6.34), there was no significant difference between groups. These authors provided insufficient data on the laser parameters used to stimulate the acupuncture point treated in this study; there was therefore insufficient evidence upon which to make a decision as to the effectiveness of laser acupuncture in the management of nocturnal enuresis.

O'Reilly et al [40] undertook a double blind study using a sample of female patients with interstitial cystitis. It was found that 12 weeks of laser acupuncture applied to the SP6 acupuncture point was no more effective than placebo intervention in easing symptoms of interstitial cystitis (SMD: −1.00; −3.11–1.11) at 3 months, or in reducing urinary output (SMD: 1.48; −21.8–24.9) at 1 month or 3 months (SMD: 9.07; −13.15–31.3). The laser device used in this study was specifically produced for daily home use by patients (stimulation of the SP6 acupuncture point for 30 seconds). However, once again the irradiation parameters used were not specified; there was therefore insufficient evidence upon which to make a decision as to the effectiveness of laser acupuncture in the management of interstitial cystitis.

Ebneshahidi et al [26] compared the effectiveness of ten sessions of laser acupuncture to placebo in the treatment of patients (n = 50) with chronic tension headaches. Laser acupuncture, applied bilaterally at eight points, using a dose of 1.3 J point, was found to be significantly more effective than placebo in reducing the intensity, duration and number of headaches suffered. There is therefore limited evidence that laser acupuncture applied at appropriate irradiation parameters is effective in the treatment of chronic tension headaches.

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5. Discussion 

This systematic review assessed the evidence to support the clinical effectiveness of laser acupuncture, principally focusing on pain management. The key finding from this review is that there is moderate evidence to support the use of this therapy in the treatment of myofascial pain when clinically appropriate irradíation parameters (i.e., power outputs of at least 10 mW and dosages of at least 0.5 J point) are applied. Beyond this, there is a moderate level of evidence (one high and one low quality trial) to support the use of laser acupuncture to manage post-operative nausea and vomiting and limited evidence of effectiveness (one low quality study) for laser acupuncture in the relief of chronic tension headache. Because of the lack of RCTs employing clinically appropriate laser irradiation parameters, it is not possible to come to any definitive conclusion about the effectiveness of laser acupuncture in the treatment of lateral epicondylalgia, nocturnal enuresis, or interstitial cystitis, nor for smoking cessation.

For the purposes of this review, clinical appropriateness of the intervention was used as an additional means of assessing evidence of the effectiveness of laser acupuncture. This included assessments of the appropriateness of the laser treatment parameters employed, as well as of the acupuncture points stimulated. The latter was undertaken by an experienced acupuncturist, and acupuncture points selected for the studies reviewed were deemed appropriate for the condition treated. However, the difficulties in making such a determination—given the range of possible combinations which would be considered acceptable—and in prescribing acupuncture points on a formulaic basis as part of a clinical trial to standardize treatment for all subjects, should be noted [41]. Determination of appropriateness of laser irradiation parameters was undertaken by one of the authors with extensive experience in laser therapy as a researcher and clinician and based upon recent recommendations by the World Association of Laser Therapy (WALT) [16]. Given the potential permutations of combinations of laser irradiation parameters (see Table 2, Table 3), we focused on setting thresholds for two of the most important parameters: radiant power output (specified average power output in mW) and dosage (specified here in Joules per point). In the case of the former, 10 mW was considered to represent a clinically appropriate threshold value for average power output, while for the latter 0.5 J per point was derived from the minimum dosage recommended by WALT (i.e., 1 J per point ± 50%).

While the results of the current review would support the use of such thresholds (i.e., positive studies were associated with the use of higher power outputs and dosages), there are limitations to such an approach which need to be recognized. In the first instance, the quality of reporting of laser irradiation parameters in the studies reviewed was highly variable: in some cases it was not possible to accurately determine the power output of the laser device used, or to estimate the dosage applied to stimulate acupuncture or trigger points. For example, in one of the earlier (and most cited) studies in this area, the research group simply indicated that Helium-Neon laser was applied for 15 seconds per point [27]. Secondly, and perhaps more importantly, while the mechanisms of action underpinning laser therapy for stimulation of tissue repair have been extensively investigated and are largely well known and accepted [42], those underpinning laser acupuncture remain occult [7, 43]. Thus while determination of appropriate or optimal treatment parameters for other types of laser therapy treatment can be informed by experimental findings which provide a scientific rationale for parameter selection [44], this is currently not possible for laser acupuncture. Therefore, although the current review provides some evidence of effectiveness which depends upon power output and dosage, it does not elucidate the likely mechanisms of action. Additionally, the current findings do not provide any clear evidence as to the potential relevance of other irradiation parameters such as wavelength and pulse repetition rate.

In keeping with findings from systematic reviews in other areas of physical medicine and rehabilitation, and in complementary and alternative medicine, the quality of the studies identified for the current review was variable; only five of the 18 papers reviewed were rated as ‘high quality’ based upon van Tulder scores. Of these higher quality studies, only two were deemed to have used clinically appropriate laser irradiation parameters [19, 22]; thus high internal validity (determined here by a well-accepted means of assessing study quality) [12], does not necessarily ensure the external validity of a study. Equally, it is important to recognize that the majority of papers underpinning the current recommendations are based upon ‘lower quality’ research trials.

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6. Summary and Implications for Future Research 

Based upon the current review, laser acupuncture can be recommended as an effective treatment (moderate level of evidence) for the reduction of myofascial pain, at least when irradiation is applied at power of at least 10 mW and a dosage of at least 0.5 J per point. For the treatment of post-operative nausea and vomiting, there is moderate evidence to support the use of laser acupuncture, applied to the P6 acupuncture point at an intensity of at least 10 mW and a dosage of at least 0.3 J per point. There is limited evidence (one positive clinical trial) [24] of the clinical effectiveness of laser acupuncture in the treatment of chronic tension headache. Findings in other areas are less conclusive (insufficient evidence), due to the limited numbers of published studies available, and (particularly in the case of lateral epicondylitis) the application of inappropriate laser treatment parameters. Beyond this, the wide heterogeneity of laser parameters employed in the studies reviewed precludes further more definitive recommendations in terms of treatment parameters. However, these results high-light the critical importance of threshold intensities and dosages to the clinical effectiveness of laser used as an alternative to needles for acupuncture treatment.

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