Superior Cluneal Nerve EntrapmentNCT06672744
Superior Cluneal Nerve Entrapment Syndrome, Kinesiotaping and Myofascial Release Techniques
A study testing Exercise, Myofascial release technique and Kinesiotaping in people with Superior Cluneal Nerve Entrapment, run by Savaş Karpuz at 1 site in Turkey (Türkiye).
Trial summary
Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Cluneal Nerve Entrapment
- What is being tested?
- Exercise, Myofascial release technique and Kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with superior cluneal nerve entrapment syndrome
Who cannot join
- those with communication problems
- those who also described pain in the mid-lumbar region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Training and Research Hospital
Konya, Selçuklu, 42060
About this study
Official title: 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 ?
- Conditions
- Superior Cluneal Nerve Entrapment
- Being tested
- Exercise, Myofascial release technique, Kinesiotaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called stretching exercises, strengthening exercises
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
Myofascial release techniqueOther
Myofascial release technique was applied by the same researcher (YY) twice a week for four weeks.
KinesiotapingOther
Kinesiotaping was performed by the same researcher (XX) for two sessions per week for four weeks with fascia correction technique
| Study group | Role | What they receive |
|---|---|---|
| exercise | Active comparator | 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. Receives: Other: Exercise |
| kinesiotaping | Experimental | 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. Receives: Other: Kinesiotaping |
| Myofascial release technique | Experimental | 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. Receives: Other: Myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoque Scale
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
Measured: Before treatment, immediately after treatment, 1 month after the end of treatment
The Roland-Morris Disability Questionnaire
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.
Measured: Before treatment, immediately after treatment, 1 month after the end of treatment
Secondary outcomes (1)
SF-36 Quality of Life Scale
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.
Measured: Before treatment, immediately after treatment, 1 month after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Aug 2022
- Primary completion15 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superior Cluneal Nerve EntrapmentStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savaş Karpuz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672744
- Sponsor's protocol ID
- 2024
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Draghici NC, Bolchis R, Popa LL, Vacaras V, Ilut S, Bashimov A, Domnita DM, Dragos HM, Vlad I, Muresanu DF. Rare entrapment neuropathies of the lower extremity: A narrative review. Medicine (Baltimore). 2024 Aug 30;103(35):e39486. doi: 10.1097/MD.0000000000039486.
PubMed 39213217
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06672744
- Acronym / sponsor ID
- 2024
- Conditions
- Superior Cluneal Nerve Entrapment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Savaş KarpuzOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise | Active comparator | Other: ExerciseLumbar 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. |
| kinesiotaping | Experimental | Other: KinesiotapingKinesiotaping 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. |
| Myofascial release technique | Experimental | Other: Myofascial release techniqueMyofascial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with superior cluneal nerve entrapment syndrome
Key exclusion criteria (2 listed)
- those with communication problems
- those who also described pain in the mid-lumbar region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: stretching exercises, strengthening exercisesLumbar 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 |
| Myofascial release techniqueMyofascial release technique was applied by the same researcher (YY) twice a week for four weeks. | Other | Myofascial release technique |
| KinesiotapingKinesiotaping was performed by the same researcher (XX) for two sessions per week for four weeks with fascia correction technique | Other | kinesiotaping |
Primary outcome
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
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.
1 secondary outcome
SF-36 Quality of Life Scale
Time frame: Before treatment, immediately after treatment, 1 month after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Results publication: PubMed 39213217Draghici NC, Bolchis R, Popa LL, Vacaras V, Ilut S, Bashimov A, Domnita DM, Dragos HM, Vlad I, Muresanu DF. Rare entrapment neuropathies of the lower extremity: A narrative review. Medicine (Baltimore). 2024 Aug 30;103(35):e39486. doi: 10.1097/MD.0000000000039486.
- Individual participant dataSharing planned: Undecided
Related trials for Superior Cluneal Nerve Entrapment
RecruitingObservational study
Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment
Superior Cluneal Nerve Entrapment, Chronic Low Back Pain
RecruitingObservational study
Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy
Cluneal Syndrome
Enrolling by invitation
Peng's "Fenjin Tuina" for Superior Cluneal Nerve Entrapment Syndrome: A Prospective, Randomized, Single-center Trial
SCNES, Superior Cluneal Nerve Entrapment Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Myofascial release technique and Kinesiotaping in people with Superior Cluneal Nerve Entrapment, run by Savaş Karpuz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analoque Scale (time frame: Before treatment, immediately after treatment, 1 month after the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.