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NCT Number: NCT05023005

Strain-Counterstrain Treatment of Piriformis Pain

The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health

Loma Linda, California, 92350, United States

Location status: Recruiting

Location contact

Mickey Lui, MD

CONTACT

909-558-1000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strain-Counterstrain treatment of piriformis muscle

Other

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Mickey Lui, DO

CONTACT

[email protected]

9095586202

Roya Vahdatinia, DO

CONTACT

[email protected]

9095586202

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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