- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755125
Effects of KinesioTaping Versus Dry Needling in the Treatment of Sacroiliac Joint Pain Among Females.
The goal of this randomized controlled trial was to investigate the effects of kinesio taping and dry needling on sacroiliac joint (SIJ) pain due to piriformis muscle tightness among females aged 20 to 50 years.
The main research questions it aimed to answer were:
Null Hypothesis (H₀):
There was no significant difference in the effectiveness of kinesio taping and dry needling on SIJ pain caused by piriformis muscle tightness.
Alternate Hypothesis (H₁):
There was a significant difference in the effectiveness of kinesio taping and dry needling on SIJ pain caused by piriformis muscle tightness.
All study participants provided both written and verbal consent. The research was prospective and randomized. The investigation was conducted on individuals between the ages of 20 and 50 during follow-up visits. According to the inclusion and exclusion criteria, a total of 45 participants were selected. Subjects who agreed to participate were randomly assigned to two groups.
Group A received a hot pack, TENS, piriformis simple stretching and isometric exercises, along with kinesio taping.
Group B received a hot pack, TENS, simple stretching and isometric exercises, along with dry needling.
Piriformis tightness was diagnosed using the Piriformis test, and by assessing hip internal rotation and adduction. Sacroiliac joint pain was detected using the Posterior Pain Provocation Test, Gaenslen's Test, and Patrick's Test. At the beginning of the treatment, all participants underwent pretest measurements using the Numeric Pain Rating Scale, Goniometer, Functional Gait Assessment, and Oswestry Disability Index.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All research participants were fully informed about the goals, duration, treatment protocols used within the boundaries of the study, any potential side effects, and concerns that could arise. All study participants provided both written and verbal consent. The research was prospective and randomized. The investigation was conducted on individuals between the ages of 20 and 50 during follow-up visits. According to the inclusion and exclusion criteria, a total of 45 participants were selected. Subjects who intended to participate were randomly assigned to two groups.
Group A received hot packs, TENS, piriformis simple stretching and isometrics, along with the use of kinesio taping.
Group B received hot packs, TENS, simple stretching and isometrics, along with the use of dry needling.
Piriformis tightness was diagnosed using the Piriformis test, and by assessing hip internal rotation and adduction, whereas sacroiliac joint pain was detected using the Posterior Pain Provocation Test, Gaenslen's Test, and Patrick's Test. At the beginning of the treatment, all participants underwent pretest measurements using the Numeric Pain Rating Scale, Goniometer, Functional Gait Assessment, and Oswestry Disability Index.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Sehat Medical Complex
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Only females were selected for the study.
- NPRS Score was between 5 to 10.
- Patients who were not have undergone surgery for SIJD.
- Patients with pain in the lower back, gluteal and groin area, and lower extremity lasting for more than 4 weeks but less than 1 year were selected.
- Patients with pain in the lower back, gluteal and groin areas, and lower extremities lasting for more than 4 weeks but less than 1 year were selected.
Exclusion Criteria:
- Musculoskeletal and neurological conditions; lumbar canal stenosis,lumbar spine surgery,vertebral fracture,neurological conditions.
- Inflammatory, autoimmune, and gynecological conditions, Active pelvic inflammatory disease,rheumatological diseases,endometriosis.
- Systemic conditions; Cancer,diabetes mellitus,intermittent vascular claudication,skin allergies.
- Phobia of needles.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio taping treatment group
Patients in Group A were treated with a hot pack, TENS, simple piriformis stretching, and isometric exercises, along with kinesio taping.
Kinesio tape was applied directly to the muscle with 50% stretch.
During the treatment, kinesio tape was applied to the patients twice a week, for a total of eight applications.
|
Patients in Group A was treated with a hot pack, TENS, simple piriformis stretch, and isometrics, along with kinesio taping.
Kinesio tape was applied directly to the muscle with 50% stretching.During the treatment, kinesio tape will be applied to the patients twice a week, eight times in total.
|
|
Experimental: Dry Needling treatment group
Patients in Group B was treated with a hot pack, TENS, simple piriformis stretch, and isometrics, along with Dry Needling of piriformis muscle.
During the treatment, Dry Needling was applied to the patients twice a week, eight times in total.
|
Patients in Group B was treated with a hot pack, TENS, simple piriformis stretch, and isometrics, along with dry needling.During the treatment, dry needling was applied to the patients twice a week, eight times in total.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Gait Assessment (FGA)
Time Frame: 2 weeks
|
The instrument consists of 10-items: gait level surface, changes in gait speed, gait with horizontal head turns, gait with vertical head turns, gait and pivot turn, step over obstacles, gait with narrow base of support, gait with eyes closed, ambulating backwards, and steps.
Each item was demonstrated to the participants by one of the raters to facilitate understanding and will graded on a four-point ordinal scale ranging from 0 (severe impairment), 1 (moderate impairment), 2 (mild impairment), to 3 (normal), with a maximum score of 30 points.
The higher the score, the better the participant's postural stability during gait.
|
2 weeks
|
|
Oswestry Disability Index (ODI):
Time Frame: 2 weeks
|
The ODI is a questionnaire containing 10 items covering disability caused by low back pain.
Each item was assessed on a six-level ordinal scale with '0' describing 'no limitation' and '5' describing 'extreme limitation or an inability to function'.
The total score is a percentage calculated by the sum of all answers divided by 50 (the maximum possible number of points) and multiplied by 100 as follows: 'Total score = (∑item scores/50) x 100'.
|
2 weeks
|
|
Numeric Pain Rating Scale (NPRS):
Time Frame: 2 Weeks
|
The NPRS was used to quantify pain intensity through an 11-point numeric continuum.
Individuals are prompted to assess their pain levels within a range from 0 (indicating an absence of pain) to 10 (representing the most extreme imaginable pain)
|
2 Weeks
|
|
Goniometer:
Time Frame: 2 weeks
|
The UG which has a transparent plastic 360° face, two movable arms, and a 1° gradation was used.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatima Baddar Dr., DPT, Sehat Medical Complex
Publications and helpful links
General Publications
- Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
- Gartenberg A, Nessim A, Cho W. Sacroiliac joint dysfunction: pathophysiology, diagnosis, and treatment. Eur Spine J. 2021 Oct;30(10):2936-2943. doi: 10.1007/s00586-021-06927-9. Epub 2021 Jul 16.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-SMC/001-31/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Sacroiliac Joint Pain
-
PainTEQ, LLCNot yet recruitingSacroiliac Joint Pain | Sacroiliac Joint Dysfunction
-
SI-BONE, Inc.Active, not recruitingSacroiliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac Disorder | Sacroiliac; FusionUnited States
-
SI-BONE, Inc.Not yet recruitingSacroiliac Joint Disruption | Degenerative Sacroiliitis | Sacro Iliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac Disorder | Sacro-iliac Joints
-
Elite College of Management Sciences, Gujranwala...CompletedSacro Iliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac DisorderPakistan
-
PainTEQ, LLCNot yet recruitingSacroiliac Joint Pain
-
Cairo UniversityNot yet recruiting
-
SI-BONE, Inc.Active, not recruitingSacroiliac Joint Pain | Sacroiliac Joint DysfunctionUnited States
-
Tri-Service General HospitalNot yet recruitingSacroiliac Joint Pain | Sacroiliac Joint Dysfunction
-
Gaziler Physical Medicine and Rehabilitation Education...CompletedSacroiliac Joint Somatic Dysfunction | Sacroiliac Joint PainTurkey (Türkiye)
-
University Health Network, TorontoCompletedSacroiliac Joint Arthritis Causing Low Back PainCanada
Clinical Trials on Kinesio Taping
-
University of BeykentRecruiting
-
Cardenal Herrera UniversityCompletedMobility Limitation | Myofascial Trigger Point Pain
-
Ataturk Training and Research HospitalUnknown
-
Istanbul Medipol University HospitalCompleted
-
Istinye UniversityCompleted
-
Cardenal Herrera UniversityCompletedMobility Limitation | Myofascial Trigger Point PainSpain
-
Norwegian School of Sport SciencesCompletedMuscle Weakness | Anterior Knee Pain | Knee SymptomsNorway
-
University of JazanCompletedMeniscus TearSaudi Arabia
-
Pamukkale UniversityNot yet recruitingTendon Injuries | Extensor Tendons of Finger AnomaliesTurkey (Türkiye)
-
Istinye UniversityNot yet recruitingHealthy Volunteers | Motor Performance | Upper Extremity Function | Perceived FunctionTurkey (Türkiye)