NCT04603703

Brief Summary

The objective of the study was to determine the effects of sacroiliac joint thrust manipulation on pain, pain pressure threshold, piriformis length and straight leg raise, in chronic 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 May 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

May 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 13, 2020

Last Update Submit

October 26, 2020

Conditions

Keywords

High Velocity Low Amplitude ThrustPiriformis SyndromeSacroiliac joint manipulation

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    Changes from baseline, Numeric Pain Rating Scale is a scale for pain starting from 0 to 10 where 0 indicates no pain and 10 indicates severe pain.

    6th Day

Secondary Outcomes (3)

  • Pressure Pain Threshold

    6th Day

  • Piriformis Length

    6th Day

  • Straight Leg Raise

    6th Day

Study Arms (2)

HVLAT Manipulation

EXPERIMENTAL

Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics, HVLAT

Other: HVLAT Manipulation

Conventional physical therapy

ACTIVE COMPARATOR

Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics

Other: Conventional Physical Therapy

Interventions

Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), HVLAT manipulation/ 1 rep/ 1set/ (3 days/ week), A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins.

HVLAT Manipulation

Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins.

Conventional physical therapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having alteast 3 months chronic Piriformis syndrome
  • FAIR test positive
  • Unilateral or bilateral Piriformis Syndrome

You may not qualify if:

  • Lumber Prolapsed Intervertebral Disc (PIVD)
  • Patients having hip osteoarthritis
  • Sacroiliatis (FABER test, Mennell's test, Sacral Thrust Test, Compression test, Distraction test, thigh thrust test)
  • Lumbosacral instability
  • Patients having any joint replacement in lumbosacral and hip regions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Rehab & Physical Therapy Centre G-8 Markaz

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (5)

  • Al-Subahi M, Alayat M, Alshehri MA, Helal O, Alhasan H, Alalawi A, Takrouni A, Alfaqeh A. The effectiveness of physiotherapy interventions for sacroiliac joint dysfunction: a systematic review. J Phys Ther Sci. 2017 Sep;29(9):1689-1694. doi: 10.1589/jpts.29.1689. Epub 2017 Sep 15.

    PMID: 28932014BACKGROUND
  • Kutty RK, Gebrekidan HG, Lerebo WT, Gebretsadik MA. Neural mobilization a therapeutic efficacy in a piriformis syndrome model: an experimental study. International journal of physiotherapy and research. 2014;2(3):577-83.

    BACKGROUND
  • Ellythy MA. Efficacy of muscle energy technique versus strain counter strain on low back dysfunction. Bulletin of Faculty of Physical Therapy. 2012;17(2).

    BACKGROUND
  • Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.

    PMID: 11525209BACKGROUND
  • Bose GNSC, Dusad G. EFFECT OF RECIPROCAL INHIBITION AND POST ISOMETRIC RELAXATION; TYPES OF MUSCLE ENERGY TECHNIQUE IN PIRIFORMIS SYNDROME-A COMPARATIVE STUDY.

    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 13, 2020

First Posted

October 27, 2020

Study Start

May 9, 2020

Primary Completion

September 8, 2020

Study Completion

September 18, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations