Evaluation of the effect of topical application of the combination of Arnica, Aconitum, Atropa belladonn, Calendula officinalis, Hypericum perforatum, Ruta graveolens and Hamamelis in relieving chronic occupational low back pain

Determining the effect of topical application of the combination of Arnica, Aconitum, Atropa belladonn, Calendula officinalis, Hypericum perforatum, Ruta graveolens and Hamamelis in relieving chronic occupational low back pain

Clinical trial with control group, with parallel groups, triple blind, randomized, phase 2-3, 20 patients in each group, randomization with random prescription of one of the packages containing the compounds or placebo.

Patients referred to the orthopedic clinic of Shahid Ghazi hospital in Sanandaj, Kurdistan province, will be included in the study according to the inclusion and exclusion criteria. In both groups, patients' demographic information will be recorded and measured by pain intensity using the Visual Analogue Pain Index and disability will be assessed using the Million Visual Analogue Scale and Oswestry questionnaire. In the case group, a combination containing the plants will be prescribed. A placebo will also be prescribed in the control group. The packaging of the compounds in the two groups is coded as A and B and researchers, patients and statistical consultants will not know the contents of the tubes until the end of the study. Patients will be followed up for two months, during which time they will be visited every 14 days.

Patients referred to orthopedic clinic. Inclusion criteria: Diagnosis of chronic occupational low back pain over 18 years of age Exclusion criteria: pregnancy, lactation, taking any analgesic and anti-inflammatory drugs except the studied compounds.

Including case and control groups: in the case group, 5.2 grams of the herbal combination will be used once every 8 hours, and in the control group, placebo will be prescribed in the same way.

Pain intensity; Pain frequency; Disability intensity; Side effects

Simple random, Individual, Random administration of medication / placebo Random allocation: First, 20 envelopes containing the letter A and the same number containing the letter B are prepared, and then without the researcher knowing the contents of each envelope, he will give one envelope to each patient and based on what letter is inside the envelope, they are placed in the case group (letter A) or control group (letter B).

Packaging of the compounds in the two groups is coded as A and B, and researchers and patients will not know the contents of the cream tubes

All information is provided upon request by qualified persons

After the publication of the study report

Relevant organizations

It is not possible to reuse data in studies. These data will be provided only to verify the results by relevant organizations such as ethics committees.

Correspondence with the authors of the article

The requester writes a letter to the corresponding author of the study and mentions his purpose of using of the documents and sends it to the email address mentioned in the article, and then the request will be seen by the authors and the ethics committee, and if approved, the documents will be sent to him in the shortest possible time (At least two weeks).