Treatment of osteoarthritis of the knee with a topical doxepin: A randomised controlled trial

Evaluation of Analgesic Effects of Doxepin Cream in patients with knee osteoarthritis

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 60 patients. Random allocation concealment was used for randomization.

This study is a double-blind, placebo-controlled, single-center clinical trial in which Randomization concealmen was performed on 60 patients with osteoarthritis referred to Rasool Akram orthopedic clinic. Patients with osteoarthritis are divided into three groups of 20 people. The first group uses placebo cream 3 times a day, the second group uses 5% topical Doxepin cream 3 times a day and the third group uses 1% diclofenac topical gel 3 times a day. All three groups take 250-500 mg of naproxen tablets orally daily. The Western Ontario and McMaster (WOMAC) and Visual Analogue Scale (VAS) questionnaires are checked at the beginning of the study and six weeks after the start of treatment. Improving physical function and reducing pain is the answer to treatment.

Inclusion criteria: 45_75 years old; a definitive diagnosis of osteoarthritis disease with specialist Exclusion criteria: severe diseases such as metabolic disorders and digestive at the same time; severe infection, sensitivity to thyme extract daenensis, pregnancy, lactation, impaired liver function tests; history of fracture or knee surgery; rheumatoid arthritis

Patients with osteoarthritis are divided into three groups of 20 people. The first group uses placebo cream twice a day, the second group consumes 5% doxepin cream 2 times a day for half a fingertip, and the third group consumes 1% diclofenac topical gel the same amount as doxepin group 2 times a day. All three groups take 250-500 mg of naproxen tablets orally daily.

Improving physical Function; Pain relief

In the present study, the simple randomization method will be used. The randomization sequence will be determined by the researchers first and then we will proceed to sampling. In this way, we will have 2 pots, in pot number 1 will be numbers from 1 to 63, and in pot number 2, 63, the number of envelopes will be opaque, in which the desired type of treatment is listed. First we will randomly select a number from the first pot and from the second pot we will randomly select an envelope and place them in a designed box. The number from pot number 1 will receive the treatment that came out of pot number 2. We will do this for every 63 issues. In fact, the type of intervention inside each envelope is unclear, which is the randomization concealment method. In fact, the treatment assigned to the numbers is not known until the person comes and the envelope is opened for him, and secondly, the names of the treatments will not be known inside the envelopes, and the names of the treatments will be A, B and C, and only the designer The study will know the type of treatment A and B, C.

In this study, the patient and the interventionist or physician are blind and the drug group and placebo are used for blinding. After selecting the samples, the patient and the intervener or physician will have no information about randomization and the allocation process. Physicians are pre-coded (A, B, C) and patients are admitted to the study, respectively.