NCT06755125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 24, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

sacroiliac joint painpiriformis muscle syndromeacupunture

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale (NPRS):

    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:

    The UG which has a transparent plastic 360° face, two movable arms, and a 1° gradation was used.

    2 weeks

  • Functional Gait Assessment (FGA)

    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):

    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

Study Arms (2)

Kinesio taping treatment group

EXPERIMENTAL

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.

Other: Kinesio Taping

Dry Needling treatment group

EXPERIMENTAL

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.

Other: Dry Needling

Interventions

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.

Kinesio taping treatment group

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.

Dry Needling treatment group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 34272605BACKGROUND
  • 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.

    PMID: 32123652BACKGROUND

Related Links

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Fatima Baddar Dr., DPT

    Sehat Medical Complex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

January 10, 2025

Primary Completion

March 18, 2025

Study Completion

March 24, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations