- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06672744
Superior Cluneal Nerve Entrapment Syndrome, Kinesiotaping and Myofascial Release Techniques
November 1, 2024 updated by: Savaş Karpuz
Comparison of the Efficacy of Kinesiotaping and Myofascial Release Techniques in the Treatment of Superior Cluneal Nerve Entrapment Syndrome: A Randomised Single Blind Controlled Trial
Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Selçuklu
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Konya, Selçuklu, Turkey, 42060
- Konya Beyhekim Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients diagnosed with superior cluneal nerve entrapment syndrome
Exclusion Criteria:
- those with communication problems
- those who also described pain in the mid-lumbar region
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: exercise
Lumbar muscles (especially quadratus lumborum) and thoracolumbar fascia stretching exercises and strengthening exercises for the lumbar and abdominal muscles were described by the physiotherapist.
Participants were asked to perform the exercises three times a day, five days a week.
|
Lumbar muscles (especially quadratus lumborum) and thoracolumbar fascia stretching exercises and strengthening exercises for the lumbar and abdominal muscles were described by the physiotherapist.
Participants were asked to perform the exercises three times a day, five days a week
Other Names:
|
|
Experimental: kinesiotaping
Kinesiotaping was performed by the same researcher (XX) for two sessions per week for four weeks with fascia correction technique.
The procedure was performed with the participant lying in the prone position.
The tape was glued just below the beginning of the iliac crista without stretching.
Submaximal tension was continued on the skin in line with the lower fibres of the quadratus lumborum muscle and thorocolumbar fascia.
It was terminated without tension at the lower costal fold.
I band was applied perpendicular to the line of insertion of the quadratus lumborum and thorocolumbar fascia to the crista iliaca with 50% tension in the middle section without tension at the beginning and end.
|
Kinesiotaping was performed by the same researcher (XX) for two sessions per week for four weeks with fascia correction technique
|
|
Experimental: Myofascial release technique
Myofascial release technique was applied by the same researcher (YY) twice a week for four weeks.
Ischaemic compression was applied to palpable trigger points on the quadratus lumborum muscle.
One hand was placed on the inferior crista iliaca and the other hand on the superior inferior costal fold and waited for 3 minutes with minimal tension.
The hand was made into a fist and minimal pressure was applied with the proximal phalanges over the quadratus lumborum and the participant was asked to contract and release the muscle for 3 minutes.
|
Myofascial release technique was applied by the same researcher (YY) twice a week for four weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analoque Scale
Time Frame: Before treatment, immediately after treatment, 1 month after the end of treatment
|
Visual Analoque Scale is a scale consisting of a single 10 cm line and assesses the intensity of pain.
Patients were asked to rate the level of pain after being informed that the beginning point on the scale represented no pain and the end point represented the most excruciating pain they had ever experienced
|
Before treatment, immediately after treatment, 1 month after the end of treatment
|
|
The Roland-Morris Disability Questionnaire
Time Frame: Before treatment, immediately after treatment, 1 month after the end of treatment
|
The Roland-Morris Disability Questionnaire is a questionnaire developed to assess functional disabilities in patients with low back pain [15].
In the questionnaire consisting of 24 sentences about functional disabilities, patients are asked to answer each sentence as yes if it fits their situation and no if it does not.
Yes answers are calculated as '1' and no answers as '0' points, resulting in a total score between 0-24, with a higher score indicating more disability.
|
Before treatment, immediately after treatment, 1 month after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36 Quality of Life Scale
Time Frame: Before treatment, immediately after treatment, 1 month after the end of treatment
|
SF-36 Quality of Life Scale is a general quality of life scale frequently used in clinical research.
The scale consists of 36 items, which measure 8 different dimensions: physical functions, social functions, role inhibition due to physical problems, physical pain, mental health, role inhibition due to emotional problems, life energy, general health perception.
The subscales assess health on a scale of 0 to 100, with higher scores indicating good health quality.
|
Before treatment, immediately after treatment, 1 month after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2022
Primary Completion (Actual)
August 15, 2024
Study Completion (Actual)
August 16, 2024
Study Registration Dates
First Submitted
October 31, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Genetic Diseases, Inborn
- Peripheral Nervous System Diseases
- Neurodegenerative Diseases
- Congenital Abnormalities
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Charcot-Marie-Tooth Disease
- Nerve Compression Syndromes
- Hereditary Sensory and Motor Neuropathy
Other Study ID Numbers
- 2024 (Other Grant/Funding Number: Rome Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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