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Strain-Counterstrain Treatment of Piriformis Pain

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ClinicalTrials.gov Identifier: NCT05023005
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Piriformis Syndrome Somatic Dysfunction of Sacral Region (Finding) Other: Strain-Counterstrain treatment of piriformis muscle Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking Description: Participant will not know the true positioning for strain counterstrain treatment of piriformis muscle versus hamstring muscle.
Primary Purpose: Treatment
Official Title: Strain-Counterstrain Treatment of Piriformis Pain
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Piriformis Strain-Counterstrain
The treatment group will receive strain-counterstrain for the piriformis muscle.
 Other: Strain-Counterstrain treatment of piriformis muscle
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.
Sham Comparator: Hamstring Strain-Counterstrain
The sham group will receive strain-counterstrain treatment for the hamstring muscle.
 Other: Strain-Counterstrain treatment of piriformis muscle
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.


Outcome Measures
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Primary Outcome Measures :
  1. Algometer - Change in pressure pain threshold [ Time Frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another. ]
    Objective improvement in pressure/pain threshold


Secondary Outcome Measures :
  1. Change in Visual Analog Scale [ Time Frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another. ]
    Subjective improvement in low back/leg pain

  2. Change in Oswestry Disability Index [ Time Frame: Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated). ]
    Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023005


Contacts
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Contact: Roya Vahdatinia, DO 9095586202 rvahdatinia@llu.edu
Contact: Mickey Lui, DO 9095586202 mlui@llu.edu

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92350
Contact: Mickey Lui, MD    909-558-1000      
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Mickey Lui Loma Linda University Health
More Information
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT05023005    
Other Study ID Numbers: 5210286
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Piriformis Muscle Syndrome
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Sciatic Neuropathy
Mononeuropathies
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Neuralgia
Pelvic Pain