Background
Methods
Protocol and registration
Search strategy
Inclusion criteria
Exclusion criteria
Study selection
Data extraction
Assessment of methodological quality
Results synthesis
Assessment of treatment adequacy
Results
Study selection
Study characteristics
Authors (Year) | Participants | Interventions (No. Participants) | Co-intervention | Outcome Measures | Measured Time Points | Conclusions | Comments | Funding Resources |
---|---|---|---|---|---|---|---|---|
Ridner et al. (2013) [49] | 46 women, unilateral BCRL | (1) LLLT (n = 15) (2) Manual lymphatic drainage (n = 16) (3) LLLT + manual lymphatic drainage (n = 15) | Compression bandaging after each Tx | I: Limb circumference | i: Baseline ii: Daily and weekly in Tx iii: Post-Tx | LLLT with bandaging may offer a time saving therapeutic option that provides similar results as those with conventional manual lymphatic drainage. | Small sample size; unaffected limb not assessed | ONS Foundation, National Center for Research Resources, the National Institutes of Health |
Omar et al. (2011) [48] | 50 women, unilateral BCRL | (1) LLLT (n = 25) (2) Sham laser (n = 25) | 1) Limb exercise 2) Skin care instructions 3) Pressure garment | I: Limb circumference II: Range of motion | i: Baseline ii: 4 wk. iii: 8 wk. iv: 12 wk. v: 16 wk | LLLT was found to be effective in reducing the limb volume, increase shoulder mobility, and hand grip strength in approximately 93% of patients with post-mastectomy lymphedema. | Not with intention-to-treat analysis | NR |
Lau and Cheing (2009) [52] | 21 women, unilateral BCRL | (1) LLLT (n = 11) (2) Waiting list (n = 10) | Education | I: Limb volume | i: Baseline ii: Post-Tx iii: 4 wks post-Tx | LLLT was effective in the management of post-mastectomy lymphedema, and the effects were maintained to the 4wk follow-up. | Small sample size; assessor not blinded | NR |
Kozanoglu et al. (2009) [50] | 47 women, unilateral BCRL | (1) LLLT (n = 23) (2) Pneumatic compression therapy (n = 24) | 1) Limb exercises 2) Hygiene 3) Skin care | I: Limb circumference II: Pain | i: Baseline ii: Post-Tx iii: 3 mo iv: 6 mo v: 12 mo | Both Tx modalities have positive effects in the treatment of post-mastectomy lymphedema, it seems that LLLT has better results at long term. | Small sample size; not with intention-to-treat analysis | NR |
Maiya et al. (2008) [51] | 20 women, unilateral BCRL | (1) LLLT (n = 10) (2) Compression bandage (n = 10) | Upper extremity exercise program | I: Limb circumference II: Pain | i: Baseline ii: Post-Tx | LLLT significantly reduces post-mastectomy lymphedema and pain compared to conventional group. | Lacked demographics; small sample size; lacked intragroup differences | NR |
Kaviani et al. (2006) [47] | 11 women, unilateral BCRL | (1) LLLT (n = 6) (2) Sham laser (n = 5) | NR | I: Limb circumference II: Pain III: Range of motion | i: Baseline ii: 3 wk. iii: 9 wk. iv: 12 wk. v: 18 wk. vi: 22 wk | LLLT may be effective in reducing arm circumference and pain, and in increasing the desire to continue Tx in patients with post-mastectomy lymphedema. | Very small sample size; not with intention-to-treat analysis | NR |
Carati et al. (2003) [46] | 61 women, unilateral BCRL | (1) LLLT (n = 33) (2) Sham laser (n = 28) | NR | I: Limb volume II: Range of motion | i: Baseline ii: Pre-Txs in C1 iii: End of C1 iv: Start of C2 v: End of C2 vi: 1 mo after C2 vii: 3 mo after C2 | Two cycles of LLLT were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately 33% of patients with post-mastectomy lymphedema at 3 months after Tx. | Two-component crossover study, only 1st phase was included for analysis | AUSIndustry grant to RIAN Corp & Flinders University |
Authors (Year) | Participants | Interventions (No. Participants) | Co-intervention | Outcome Measures | Measured Time Points | Conclusions | Comments | Funding Sources |
---|---|---|---|---|---|---|---|---|
Mayrovitz and Davey (2011) [54] | 38 women, unilateral BCRL; 38 subjects (19 M/19 F), secondary leg lymphedema | (1) LLLT (n = 76) (2) Sham laser (n = 17 secondary ley lymphedema) | Manual lymphatic drainage: following (1) and (2) | Limb circumference | i: Baseline ii: Post-Tx iii: Post a manual lymphatic drainage | LLLT would reduce the skin water and tissue indentation resistance in patients with arm or leg lymphedema. | Observational study in Phase 1- LLLT (n = 76), sham laser in Phase 2- secondary leg lymphedema only | NR |
Dirican et al. (2011) [55] | 17 women, unilateral BCRL limited responsive to current therapy | LLLT (n = 17) | Conventional Tx | I: Limb circumference II: Pain III: Range of motion | i: Baseline ii: End of Cycle 1 iii: End of Cycle 2 | Patients with BCRL received additional benefits from LLLT when used in conjunction with standard treatment. Two cycles were found to be superior. | Small sample size; statistical methods not clear | NR |
Piller and Thelander (1995/ | 10 women, unilateral BCRL | LLLT (n = 10) | Skin care instructions | I: Limb circumference II: Limb volume | i: Baseline, ii: Biweekly in Tx iii: 1 mo post-Tx iv: 3 mo post-Tx v: 6 mo post-Tx vi: 36 mo post-Tx* | LLLT, at least initially, improved most objective and subjective parameters of arm lymphedema. | Small sample size; lacked demographics; statistical significance unknown | Flinders 2000 & Flinders University |
Methodological quality assessment of RCTs
Reference | 1. Eligibility criteria | 2. Random allocation | 3. Concealed allocation | 4. Baseline comparability | 5. Blinded subjects | 6. Blinded therapists | 7. Blinded assessors | 8. Adequate follow-up | 9. Intention-to-treat analysis | 10. Between-group comparisons | 11. Point measures and variability | Total score (_/10)¶ (criteria 1 not included) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Ridner et al. 2013 [49] | Yes | Yes | No | Yes | No | No | No | Yes | Yes | Yes | Yes |
6
|
Omar et al. 2011 [48] | Yes | Yes | No | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
7
|
Lau and Cheing 2009 [52] | Yes | Yes | No | Yes | No | No | No | No | No | Yes | Yes | 4 |
Kozanoglu et al. 2009 [50] | Yes | No | Yes | Yes | No | No | No | Yes | No | Yes | Yes |
5
|
Maiya et al. 2008 [51] | Yes | Yes | No | No | No | No | No | Yes | Yes | Yes | Yes |
5
|
Kaviani et al. 2006 [47] | Yes | Yes | No | Yes | Yes | Yes | No | No | No | Yes | No |
5
|
Carati et al. 2003* [46] | Yes | Yes | No | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
8
|
Sub-item total score (_/7) | 7 | 6 | 1 | 6 | 3 | 2 | 1 | 5 | 3 | 7 | 6 |
Effectiveness of LLLT (PBM)
Studies | Limb circumference/volume | Pain intensity | Range of motion | |||
---|---|---|---|---|---|---|
Immediately after end of all sessions | Short-term follow-up (< 6 months) | Immediately after end of all sessions | Short-term follow-up (< 6 months) | Immediately after end of all sessions | Short-term follow-up (< 6 months) | |
LLLT (PBM) vs. sham laser | ||||||
Omar et al. 2011 [48] | + | + | NR | NR | + | NR |
Kaviani et al. 2006 [47] | NR | +* | NR | + | NR | – |
Carati et al. 2003 [46] | – | +* | NR | NR | – | – |
LLLT (PBM) vs. conventional therapy | ||||||
Ridner et al. 2013 [49] | – | NR | NR | NR | NR | NR |
Kozanoglu et al. 2009 [50] | + | – | – | – | NR | NR |
Maiya et al. 2008 [51] | + | NR | + | NR | NR | NR |
LLLT (PBM) vs. a waiting list control | ||||||
Lau and Cheing 2009 [52] | – | + | NR | NR | NR | NR |
LLLT (PBM) versus sham laser (n = 3)
LLLT (PBM) versus conventional therapy (n = 3)
LLLT (PBM) versus a waiting list control (n = 1)
Application of LLLT (PBM)
Study | Laser type/model | Treatment Area | Treatment Parameters | Laser parameters (output/power density/dose, when available) |
---|---|---|---|---|
Ridner et al. (2013) [49] | RianCorp LTU 904 | Limb region | 20–30 s/point; 20 min session | NR |
Mayrovitz and Davey (2011) [54] | RianCorp LTU 904H | Limb region, 5 points | 1 min/point; 5 min/session | 5 mW output; 904 nm wavelength; in pulsed mode [Calculated: 0.3 J per point, 1.5 J total energy] |
Dirican et al. (2011) [55] | RianCorp LTU-904 | Axillary region, 17 points | 1 min/point; two Tx cycles of 3 times/wk. for 3 weeks | 0.3 J per point; 904 nm |
Omar et al. (2011) [48] | Pagani IR27/4, GaAs | Antecubital fossa, 3 points; Axillary region, 7 points | 2 min/point; 20 min/session, 3 times/wk. for 12 weeks | 5 mW output; 904 nm; (maximum frequency of 2800 Hz, pulse duration of 50 ns); average dosage of 1.5 J/cm2
|
Lau and Cheing (2009) [52] | Comby 3 Terza Serie, Model D | Axillary region | Estimated Tx area of 144 cm2; 20 min/session, 3 times/wk. for 4 weeks | Three sources: 808 nm and ×2 905 nm, with outputs 24 mW–500 mW maximum. Combined emission mode with average dosage of 2 J/cm2
|
Kozanoglu et al. (2009) [50] | Electronica Pagani IR27/4, GaAs 904 nm | Antecubital fossa; Axillary region | 20 min/session, 3 times/wk. for 4 weeks | 904 nm wavelength in pulsed mode (frequency of 2800 Hz); dosage of 1.5 J/cm2
|
Maiya et al. (2008) [51] | He-Ne 632.8 nm laser device and Diode 850 nm laser | Axillary region | 34 min/session, daily for 10 days | 632.8 nm and 850 nm; dosage of 2.4 J/cm2
|
Kaviani et al. (2006) [47] | Mustang-024, GaAs diode laser device | Axillary region, 5 points | Two LLLT blocks (3 times/wk. for 3 weeks) with an 8-wk. interval (18 sessions in total) | 10 W maximum output power, 890 nm wavelength in pulsed mode (frequency of 3000 Hz, pulse width of 130 ns, emission power of 4 mJ/s); dosage of 1.5 J/cm2
|
Carati et al. (2003) [46] | RianCorp LTU 904H | Axillary region, 17 points | 1 min/point; 17 min/session; two LLLT blocks (3 times/wk. for 3 weeks) with an 8-wk. interval | 5 mW average output; 904 nm wavelength in pulsed mode; dosage of 1.5 J/cm2
|
Space Mid M3-UP Helium Neon laser device | Axillary region; forearm; upper arm | 30 min/session; 16 sessions (2 times/wk. for 6 weeks followed by 1 time/wk. for 4 weeks) | 6.5 mw output power per course; 632.8 nm wavelength (Helium Neon laser); 14 mW average output power; 904 nm wavelength (semiconductor diode infrared lasers); treatment dosage ranged 2–4 J/cm2
|