NCT04588779

Brief Summary

The objective of our study is to compare the effects of Graston and manual myofascial release technique on pain, muscle length and functional status in patients with Piriformis syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 11, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Keywords

Graston techniqueMyofascial releaseLower extremity functional scalePiriformis syndrome

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    Changes from baseline and after 1st session, Numeric pain rating scale is a scale from 0 to 10. 0 indicating no pain and 10 indicating worse pain.

    9th day

  • Piriformis muscle length

    Changes from baseline and after 1st session, in prone lying range of internal rotation is measured for piriformis muscle length

    9th day

  • Lower extremity functional scale

    Changes from baseline and after 1st session, lower extremity functional scale is used to measure the functional status of patients with piriformis syndrome.

    9th day

Secondary Outcomes (1)

  • Straight leg raise

    9th day

Study Arms (2)

Graston

EXPERIMENTAL

Ultrasound, Graston technique, piriformis stretching, home plan (hip abductor and extensor strengthening)

Other: Graston

Manual myofascial release

ACTIVE COMPARATOR

Ultrasound, Manual myofascial release, piriformis stretching, home plan (hip abductor and extensor strengthening)

Other: Manual myofascial release

Interventions

GrastonOTHER

Ultrasound for 10 mins/1 set/ (3 sessions/week), Graston for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks), A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.

Graston

Ultrasound for 10 mins/1 set/ (3 sessions/week), Manual myofascial release for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks), A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.

Manual myofascial release

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAccording to the feasibility of patients and examiner for assessment, only female patients were included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain more than 1 month.
  • Piriformis syndrome diagnosed through screening test (FAIR test, Beatty test, Freiberg test, Sign of Pace)

You may not qualify if:

  • Leg pain due to causes other than piriformis syndrome.
  • Congenital spinal deformity.
  • History of fracture.
  • History of back or hip surgery.
  • Any systemic illness like metastatic or infective disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal government polyclinic hospital

Islamabad, Fedral, 46000, Pakistan

Location

Related Publications (5)

  • Kukadia HA, Malshikare A, Palekar TJ. Effect of Passive Stretching v/s Myofascial Release in Improving Piriformis Flexibility in Females-A Comparative Study. Indian Journal of Physiotherapy and Occupational Therapy-An International Journal. 2019;13(4):57-61.

    BACKGROUND
  • Stanek J, Sullivan T, Davis S. Comparison of Compressive Myofascial Release and the Graston Technique for Improving Ankle-Dorsiflexion Range of Motion. J Athl Train. 2018 Feb;53(2):160-167. doi: 10.4085/1062-6050-386-16. Epub 2018 Jan 26.

    PMID: 29373060BACKGROUND
  • Lee JH, Lee DK, Oh JS. The effect of Graston technique on the pain and range of motion in patients with chronic low back pain. J Phys Ther Sci. 2016 Jun;28(6):1852-5. doi: 10.1589/jpts.28.1852. Epub 2016 Jun 28.

    PMID: 27390432BACKGROUND
  • Kim D-H, Ms T-HK, Jung D-Y, Weon J-H. Effects of the graston technique and self-myofascial release on the range of motion of a knee joint. Journal of Korean Society of Physical Medicine. 2014;9(4):455-63.

    BACKGROUND
  • Awan WA, Babur MN. EFFECTIVENESS OF DEEP FRICTION MASSAGE & STRETCHING EXERCISES IN PIRIFORMIS SYNDROME. IJCRB. 2011:378.

    BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Asghar Khan, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know which treatment techniques are given in the specified groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both groups were treated simultaneously with their specified treatment techniques within given duration.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

January 11, 2020

Primary Completion

September 17, 2020

Study Completion

September 24, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations