Complementary Medicine Practices in Chronic Low Back Pain: Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Back Pain; Leeches; Chronic Pain
• Interventions: Other: Conventional Physiotherapy; Other: Leech; Other: Kinesiotape

• Registration Number: NCT06407492
• Lead Sponsor: Uskudar University

Brief Summary

To compare the effectiveness of classical physiotherapy and leech therapy in patients with chronic low back pain.

Detailed Description

investigators research will last 6 weeks in total. There will be a total of 60 participants in three groups, 20 people in each group. Participation will be on a voluntary basis. There will be no control group in our study. Physiotherapy treatments will be applied two days a week for a total of 6 weeks. In the group where leeches will be applied together with classical physiotherapy, leech application will be done every two weeks. However, in the group where leeches will be applied, the classical physiotherapy method will continue to be applied two days a week for a total of 6 weeks. Roland Morris Disability Questionnaire, Oswestry Disability Index, Short Form McGill Pain Questionnaire, Pittsburgh Sleep Quality Inventory (PSQI) will be administered before and after our study.

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study Start: 2024-05-09
• Study First Posted: 2024-05-09
• Status Verified: 2024-07
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Physiotherapy	Conventional Physiotherapy	transcutaneous electrical nerve stimulation, Hotpack, US.
Leech Therapy	Conventional Physiotherapy	Leech Therapy
Kinesiotape	Conventional Physiotherapy	Kinesiotape Practice
Leech Therapy	Leech	Leech Therapy
Kinesiotape	Kinesiotape	Kinesiotape Practice

Primary Outcome Measures

Name	Time	Method
Short Form McGill Pain Questionnaire	8 weeks	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.
Pittsburgh Sleep Quality Scale (PSQI)	8 weeks	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".
Oswestry Disability Index	8 weeks	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.
Roland Morris Disability Questionnaire	8 weeks	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.

Trial Locations

Locations (1)

Uskudar university; 🇹🇷 Istanbul, Turkey