NCT05660005

Brief Summary

Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 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

March 8, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

3.2 years

First QC Date

December 5, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

Piriformis syndromePainhiprange of motionsciatica

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    The severity of sciatic pain extending along the hip and leg was questioned with the Visual Analog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)

    4 weeks

Secondary Outcomes (6)

  • Extension Range of motion of the hip angle

    4 weeks

  • Flexion Range of motion of the hip angle

    4 weeks

  • Adduction Range of motion of the hip angle

    4 weeks

  • Abduction Range of motion of the hip angle

    4 weeks

  • External Rotation Range of motion of the hip angle

    4 weeks

  • +1 more secondary outcomes

Study Arms (3)

Piriformis Muscle Stretching

ACTIVE COMPARATOR

Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.

Other: Muscle Stretching

Piriformis Muscle Self Myofascial Release

ACTIVE COMPARATOR

The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).

Other: Self Myofascial Release

Control Group

EXPERIMENTAL

The individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening

Other: home exercises

Interventions

Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants. With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position. Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.

Also known as: Piriformis Muscle Stretching
Piriformis Muscle Stretching

The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body. They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball. Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight. There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).

Piriformis Muscle Self Myofascial Release

The exercise brochure consists of 5 different exercises that include isometric and isotonic strengthening of the hip and surrounding muscles. Isometric contraction of gluteus maximus, hip march, external/internal rotation of hips with theraband, 4 sided straight leg raises were the exercises and prescribed 5 days a week, 10 repetitions, 3 sets. All participants were advised to use analgesics determined by the physician in case of unbearable pain and to apply a hot pack for 10-20 minutes before sessions.

Control Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants
  • Aged 20 to 40 years
  • Presented leg or hip posterior compartment pain
  • Diagnosed with chronic PS and without any other source of pain

You may not qualify if:

  • Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;
  • Limb length discrepancy,
  • Recent buttock trauma,
  • Deep gluteal syndrome,
  • Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,
  • Fibromyalgia, myofascial pain syndrome
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Ergezen

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Piriformis Muscle SyndromePainSciatica

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gizem Ergezen, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Mustafa Sahin, PhD

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 21, 2022

Study Start

March 8, 2019

Primary Completion

May 7, 2022

Study Completion

December 3, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations