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Strain-Counterstrain Treatment of Piriformis Pain

Primary Purpose

Low Back Pain, Mechanical, Piriformis Syndrome, Somatic Dysfunction of Sacral Region (Finding)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strain-Counterstrain treatment of piriformis muscle
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 to 65 years of age
  • Tender point (or trigger point) in piriformis muscle determined by physical exam

Exclusion criteria:

  • Less than 45 degrees of active hip flexion, less than 5 degrees of active hip internal rotation or less than 30 degrees of active hip external rotation, on side of affected piriformis
  • Unable to lay prone
  • Non-English speaker
  • Inability to attend 2 sessions within the same month
  • Active cancer
  • Pregnant
  • Diagnosis of lumbar radiculopathy
  • Greater than grade 1 lumbar spondylolisthesis
  • Presence of lumbar region Pars Defect
  • Receiving massage, acupuncture, chiropractic treatments, osteopathic treatments during study period.

Sites / Locations

  • Loma Linda University HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Piriformis Strain-Counterstrain

Hamstring Strain-Counterstrain

Arm Description

The treatment group will receive strain-counterstrain for the piriformis muscle.

The sham group will receive strain-counterstrain treatment for the hamstring muscle.

Outcomes

Primary Outcome Measures

Algometer - Change in pressure pain threshold
Objective improvement in pressure/pain threshold

Secondary Outcome Measures

Change in Visual Analog Scale
Subjective improvement in low back/leg pain
Change in Oswestry Disability Index
Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living

Full Information

First Posted
August 11, 2021
Last Updated
February 16, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05023005
Brief Title
Strain-Counterstrain Treatment of Piriformis Pain
Official Title
Strain-Counterstrain Treatment of Piriformis Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.
Detailed Description
There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle. There will be two treatments, 1-2 weeks apart ideally. Participants will fill out the Oswestry Disability Index Questionnaire before the first treatment and after the second treatment (which is 1-2 weeks after the first treatment). Participants will also identify pain using the Visual Analog Scale (VAS) before and after each treatment. Participants will identify pain at rest prior to treatment using VAS. Participant will then identify pain at the start of treatment while pressure is applied to the piriformis muscle (4.5kg/cm2) and post treatment while pressure is applied to the piriformis muscle (4.5 kg/cm2). An algometer will be used pre and post each treatment (2 treatments that are 1-2 weeks apart) to objectively measure any change in pain pressure threshold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical, Piriformis Syndrome, Somatic Dysfunction of Sacral Region (Finding)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle.
Masking
ParticipantOutcomes Assessor
Masking Description
Participant will not know the true positioning for strain counterstrain treatment of piriformis muscle versus hamstring muscle.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piriformis Strain-Counterstrain
Arm Type
Experimental
Arm Description
The treatment group will receive strain-counterstrain for the piriformis muscle.
Arm Title
Hamstring Strain-Counterstrain
Arm Type
Sham Comparator
Arm Description
The sham group will receive strain-counterstrain treatment for the hamstring muscle.
Intervention Type
Other
Intervention Name(s)
Strain-Counterstrain treatment of piriformis muscle
Intervention Description
Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.
Primary Outcome Measure Information:
Title
Algometer - Change in pressure pain threshold
Description
Objective improvement in pressure/pain threshold
Time Frame
Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Secondary Outcome Measure Information:
Title
Change in Visual Analog Scale
Description
Subjective improvement in low back/leg pain
Time Frame
Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Title
Change in Oswestry Disability Index
Description
Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living
Time Frame
Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 to 65 years of age Tender point (or trigger point) in piriformis muscle determined by physical exam Exclusion criteria: Less than 45 degrees of active hip flexion, less than 5 degrees of active hip internal rotation or less than 30 degrees of active hip external rotation, on side of affected piriformis Unable to lay prone Non-English speaker Inability to attend 2 sessions within the same month Active cancer Pregnant Diagnosis of lumbar radiculopathy Greater than grade 1 lumbar spondylolisthesis Presence of lumbar region Pars Defect Receiving massage, acupuncture, chiropractic treatments, osteopathic treatments during study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roya Vahdatinia, DO
Phone
9095586202
Email
rvahdatinia@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mickey Lui, DO
Phone
9095586202
Email
mlui@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mickey Lui
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickey Lui, MD
Phone
909-558-1000

12. IPD Sharing Statement

Plan to Share IPD
No

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Strain-Counterstrain Treatment of Piriformis Pain

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