Chronic Pain Clinical Trial
Official title:
Comparison of the Effectiveness of Conventional Physiotherapy and Traditional Methods ın the Treatment of Chronic Back Pain
NCT number | NCT06407492 |
Other study ID # | Uskudar3 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2024 |
Est. completion date | August 1, 2024 |
To compare the effectiveness of classical physiotherapy and leech therapy in patients with chronic low back pain.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - By a specialist physician (orthopedics, neurology, algology) for more than three months - low back pain confirmed throughout - Complaint of lower back pain at least three days a week in the three months before treatment - Those who do not have any blood disease - Those who do not use blood thinners Exclusion Criteria: - Regular intake of opioid analgesics - Presence of hemophilia - Presence of anemia or known erythropoietic disorder - Presence of erosive gastritis, gastrointestinal bleeding or stomach ulcer in the last three months - Immunosuppressive drugs - Wound healing disorder - Pregnancy, breastfeeding status - Presence of rheumatoid arthritis, spondyloarthropathy or other inflammatory joint disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Uskudar university | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Uskudar University |
Turkey,
Barzegar A, Azizi A, Faridi P, Mohagheghzadeh A. Leech therapy in Iranian traditional medicine. Forsch Komplementmed. 2015;22(1):50-3. doi: 10.1159/000377690. Epub 2015 Feb 20. No abstract available. — View Citation
Koeppen D, Aurich M, Rampp T. Medicinal leech therapy in pain syndromes: a narrative review. Wien Med Wochenschr. 2014 Mar;164(5-6):95-102. doi: 10.1007/s10354-013-0236-y. Epub 2013 Oct 1. — View Citation
Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27. — View Citation
Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000. — View Citation
Yantis MA, O'Toole KN, Ring P. Leech therapy. Am J Nurs. 2009 Apr;109(4):36-42; quiz 43. doi: 10.1097/01.NAJ.0000348601.01489.77. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Form McGill Pain Questionnaire | The Short Form McGill Pain Questionnaire (SF-MAA) is a questionnaire developed to assess pain. It contains a total of 15 items examining different aspects of pain, with two sub-questions: sensory pain (11 items) and affective pain (4 items). Each item is evaluated with a 4-point Likert-type survey, scoring between 0-3 (0: not at all, 3: severe), and the sum of the item scores gives the pain score. The total pain score takes a value between 0 and 45 (0: no pain, 45: severe pain). The Short Form McGill Pain Questionnaire is widely used in studies on chronic pain and is stated to have strong psychometric properties. | 8 weeks | |
Primary | Oswestry Disability Index | It was developed to evaluate the degree of loss of function in low back pain. Items question pain severity, self-care, lifting and carrying loads, walking, sitting, standing, sleeping, degree of pain change, travel and social life. Under each item there are six statements in which the patient ticks the one appropriate to his/her situation. The first statement is scored as "0" and the sixth statement is scored as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100" and the minimum score is "0". As the total score increases, the disability level also increases. | 8 weeks | |
Primary | Pittsburgh Sleep Quality Scale (PSQI) | Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality". | 8 weeks | |
Primary | Roland Morris Disability Questionnaire | It is a questionnaire developed to evaluate functional disabilities in patients with low back pain. In the survey consisting of 24 sentences about functional disabilities, patients are asked to answer each sentence with yes if it applies to their situation, or no if it does not. Yes answers are calculated as "1" and no answers are calculated as "0" points, resulting in a total score between 0-24, with a higher score indicating more apology. | 8 weeks |
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