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

NCT ID: NCT06407492

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2024-07-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Back Pain Leeches Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Physiotherapy

transcutaneous electrical nerve stimulation, Hotpack, US.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type OTHER

Conventional physiotherapy applications were performed. Physiotherapy applications were performed with transcutaneous electrical nerve stimulation, hotpack and ultrasound.

Leech Therapy

Leech Therapy

Group Type EXPERIMENTAL

Leech

Intervention Type OTHER

The leeches used in the treatment were obtained from people producing in culture media. Leech therapy was applied to the patients once a week. Before coming to treatment, patients were warned not to use perfume or apply any chemicals on the skin. While no skin preparation was made before the treatment, in patients with cold legs, the area where the leech would be applied was heated to ensure easy adhesion of the leech. The leeches left on their own after approximately 40 to 38 minutes, but the leeches that did not release on their own until 60 minutes were removed by scraping them from the skin with the help of a gauze. The leeches used in the treatment were used only once and the used ones were disposed of by throwing them into medical waste bags. After the leeches were removed from the patient, the wound was covered with a printed bandage. Patients were instructed to remove the bandage after 10-12 hours.

Conventional Physiotherapy

Intervention Type OTHER

Conventional physiotherapy applications were performed. Physiotherapy applications were performed with transcutaneous electrical nerve stimulation, hotpack and ultrasound.

Kinesiotape

Kinesiotape Practice

Group Type EXPERIMENTAL

Conventional Physiotherapy

Intervention Type OTHER

Conventional physiotherapy applications were performed. Physiotherapy applications were performed with transcutaneous electrical nerve stimulation, hotpack and ultrasound.

Kinesiotape

Intervention Type OTHER

In this taping technique, skin color, 5cmX5m kinesio tape material was used. Again, the patient standing upright will be prepared in terms of clothing and skin. The standing patient will then be asked to lean forward. Taping will be done using a special "muscle technique" for this group. When applying tape to the right paravertebral region, first the lower end of the tape will be adhered 7 cm below the sacroiliac joint, at the level of the paravertebral muscles. When applying tape to the left paravertebral region, the same procedure will be done in reverse as on the right, and the tape will not be stretched at all. The third tape will be applied to the patient who is standing upright and bending slightly forward, passing over the sacroiliac joints and parallel to the ground, with the tape stretched by 25%.

Interventions

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Leech

The leeches used in the treatment were obtained from people producing in culture media. Leech therapy was applied to the patients once a week. Before coming to treatment, patients were warned not to use perfume or apply any chemicals on the skin. While no skin preparation was made before the treatment, in patients with cold legs, the area where the leech would be applied was heated to ensure easy adhesion of the leech. The leeches left on their own after approximately 40 to 38 minutes, but the leeches that did not release on their own until 60 minutes were removed by scraping them from the skin with the help of a gauze. The leeches used in the treatment were used only once and the used ones were disposed of by throwing them into medical waste bags. After the leeches were removed from the patient, the wound was covered with a printed bandage. Patients were instructed to remove the bandage after 10-12 hours.

Intervention Type OTHER

Conventional Physiotherapy

Conventional physiotherapy applications were performed. Physiotherapy applications were performed with transcutaneous electrical nerve stimulation, hotpack and ultrasound.

Intervention Type OTHER

Kinesiotape

In this taping technique, skin color, 5cmX5m kinesio tape material was used. Again, the patient standing upright will be prepared in terms of clothing and skin. The standing patient will then be asked to lean forward. Taping will be done using a special "muscle technique" for this group. When applying tape to the right paravertebral region, first the lower end of the tape will be adhered 7 cm below the sacroiliac joint, at the level of the paravertebral muscles. When applying tape to the left paravertebral region, the same procedure will be done in reverse as on the right, and the tape will not be stretched at all. The third tape will be applied to the patient who is standing upright and bending slightly forward, passing over the sacroiliac joints and parallel to the ground, with the tape stretched by 25%.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve TOLMAÇ

Role: STUDY_CHAIR

Uskudar University

Locations

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Uskudar university

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27634093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25824405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24081747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22124445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19325315 (View on PubMed)

Other Identifiers

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Uskudar3

Identifier Type: -

Identifier Source: org_study_id

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