Loma Linda University Health
Loma Linda, California, 92350, United States
Location status: Recruiting
NCT Number: NCT05023005
The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Loma Linda, California, 92350, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Objective improvement in pressure/pain threshold
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
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
Contact information is provided by the study sponsor or research team.
Mickey Lui, DO
CONTACT
Roya Vahdatinia, DO
CONTACT
Loma Linda University
Other
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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