Clinical trial NCT06407492: Complementary Medicine Practices in Chronic Low Back Pain: Randomized Controlled Trial
Official title: Comparison of the Effectiveness of Conventional Physiotherapy and Traditional Methods ın the Treatment of Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Leeches
Chronic Pain
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form McGill Pain Questionnaire
timeFrame: 8 weeks
measure: Oswestry Disability Index
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Scale (PSQI)
timeFrame: 8 weeks
measure: Roland Morris Disability Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar university
Study officials:
affiliation: Uskudar University
name: Merve TOLMAÇ
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
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.