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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04170816
Other study ID # 80576354-050-99/167
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 1, 2020

Study information

Verified date November 2019
Source Kars State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).


Description:

A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- having no abnormal results in routine blood tests

- having no known acute or chronic inflammatory disease

- an education level required for understanding the applied treatment, interventions

Exclusion Criteria:

- malignancies

- active infection

- history of common inflammatory rheumatic disease

- trauma in spinal area, skin lesion, presence of infection or open wounds

- radiculopathy

- peripheral circulation disorder

- use of warfarin due to coagulopathy

- arthropathy

- congenital or acquired spinal pathology

- pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dry needling
DN and KT therapy will be applied 3 sessions in 1-week intervals

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kars State Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Pain pressure threshold Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported 3 week
Primary Pain by visual analog scale (VAS) Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain. 3 week
Primary Oswestry disability Index (ODI) Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5. 3 week
Primary Beck Depression Inventory This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression. 3 week