NCT06672744

Brief Summary

Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

October 31, 2024

Last Update Submit

November 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Before treatment, immediately after treatment, 1 month after the end of treatment

Secondary Outcomes (1)

  • SF-36 Quality of Life Scale

    Before treatment, immediately after treatment, 1 month after the end of treatment

Study Arms (3)

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.

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.

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.

Other: Myofascial release technique

Interventions

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

Also known as: stretching exercises, strengthening exercises
exercise

Myofascial release technique was applied by the same researcher (YY) twice a week for four weeks.

Myofascial release technique

Kinesiotaping was performed by the same researcher (XX) for two sessions per week for four weeks with fascia correction technique

kinesiotaping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with superior cluneal nerve entrapment syndrome

You may not qualify if:

  • those with communication problems
  • those who also described pain in the mid-lumbar region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

ExerciseMuscle Stretching ExercisesMyofascial Release Therapy

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

August 15, 2022

Primary Completion

August 15, 2024

Study Completion

August 16, 2024

Last Updated

November 4, 2024

Record last verified: 2024-11

Locations