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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Selçuklu
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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
Other Names:
  • stretching exercises
  • strengthening exercises
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.
Other: Kinesiotaping
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.
Other: Myofascial release technique
Myofascial release technique was applied by the same researcher (YY) twice a week for four weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Savaş Karpuz

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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