Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)
Клучни зборови
Апстракт
Опис
To achieve the proposed objective, it will be performed a randomized, triple-blind (patients, therapists, and outcome assessors), placebo-controlled trial.
Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT.
In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist.
The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor.
Statistical analyzis:
- The Fischer's Exact Test will be conducted to compare the proportion of successes between groups.
- The Unpaired t-test will be used for demographic data.
- Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p<0.05.
Датуми
| Последен пат проверено: | 06/30/2020 |
| Прво доставено: | 07/08/2020 |
| Поднесено е проценето запишување: | 07/12/2020 |
| Прво објавено: | 07/16/2020 |
| Последното ажурирање е доставено: | 07/12/2020 |
| Последно ажурирање објавено: | 07/16/2020 |
| Крај на датумот на започнување на студијата: | 07/14/2020 |
| Проценет датум на примарно завршување: | 09/01/2020 |
| Проценет датум на завршување на студијата: | 09/29/2020 |
Состојба или болест
Интервенција / третман
Device: Active PBMT
Device: Placebo PBMT
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: Active PBMT Active PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions). | Device: Active PBMT Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region. |
| Placebo Comparator: Placebo PBMT Placebo PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions). | Device: Placebo PBMT The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: - Patients with chronic non-specific low back pain, with symptoms present for at least three months; - Patients with a pain intensity of at least 50mm (measured by a 0-100 mm Visual Analog Scale); Exclusion Criteria: - Serious spinal pathologies (such as fractures, tumors, inflammatory, and infectious diseases); - Patients who used local corticosteroids and/or botulin toxin injection for pain relief within the prior 30 days of the beginning of the study; - Chronic pain diseases as fibromyalgia and diabetic type 1; - Neuropathic pain; - Previous spinal surgery in the past 12 months; - Cancer patients; - Pregnancy or breast feeding. |
Исход
Мерки на примарниот исход
1. Pain intensity [3 weeks (end of treatment)]
Секундарни мерки на исходот
1. Subject satisfaction [3 weeks (end of treatment).]
2. Control of concomitant medication intake [3 weeks (end of treatment).]
3. Pain intensity [24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.]
