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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Comparison of the Effectiveness of Conventional Physiotherapy and Traditional Methods ın the Treatment of Chronic Back Pain

Conditions

Back Pain, Leeches, Chronic Pain

Being tested

Leech, Conventional Physiotherapy, Kinesiotape

Medical subject headings

Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• LeechOther

  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 PhysiotherapyOther

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

• KinesiotapeOther

  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%.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 8 weeks

2. 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.

   Measured: 8 weeks

3. 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".

   Measured: 8 weeks

4. 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.

   Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 May 2024
2. Study start9 May 2024
3. Primary completion19 Jul 2024
4. Study completion19 Jul 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (5)Papers the sponsor has linked to this study.
• Other trials for Back PainStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.