Clinical Correlates of Pressure Pain Thresholds in Back and Leg Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-10-09

Brief Summary

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Objectives: The purpose of this study was to determine whether tenderness and other commonly used chiropractic measures, when operationalized, improve after lumbar chiropractic manipulative therapy (CMT) in patients with lower back and/or leg pain. A secondary aim was to determine whether changes in tenderness as measured using algometry, correlate with other commonly used measures before and after care.

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Detailed Description

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Across manual therapy professionals there is at present little agreement regarding how to quantitatively measure painful spinal lesions associated with uncomplicated back and/or leg pain.{Waddell, 1996 #564;Hegmann KT, 2019 #16740;Himelfarb I, 2020 #16733} In the United States, the Medicare program requires "pain and tenderness" reportage as a metric to diagnose spinal lesions (segmental dysfunction, or SDF) associated with uncomplicated back pain, prior to reimbursement of treatment by chiropractors.{Services, 2019 #16731} Medicare guidelines for chiropractors specifically list use of algometry as an acceptable way to record paraspinal tenderness.{CMS, 2019 #16198} However, research regarding paraspinal algometry to measure tenderness has to date yielded conflicting results.{Jung, 2023 #16196} Medicare suggests use of pain scales such as the Numeric Rating Scale (NRS) for reporting pain levels before, during, and after chiropractic care to determine when patients have achieved maximum improvement, are pain free, and therefore no longer eligible for reimbursement of spinal manipulation (SM), the primary component of chiropractic manipulative therapy (CMT).{CMS, 2019 #16198} While there is some prior research that correlates pain with paraspinal tenderness measured using algometry, there is no body of literature correlating these findings with other commonly used clinical variables required by Medicare for documentation, either before or after CMT.{Leach, 1993 #15773;Jung, 2023 #16196;Nim, 2022 #16201} For example, both Medicare and chiropractic practice guidelines advocate for clinicians to distinguish uncomplicated back pain associated with facet joint lesions (also considered SDF), from back and leg pain that may be caused by disc lesions. One of the clinical tests for this is a pain provocation measure known as the Kemp Test (or Kemp; the patient extends their trunk backwards and to the right or left, to see if back and/or leg pain are reported. Complaint of back pain only suggests "facet syndrome" while complaint of leg pain suggests "disc syndrome.").{CMS, 2019 #16198;Hawk, 2020 #16139;Editors, 2024 #16738} As presently used there is only weak clinical evidence for use of pain provocation tests such as Kemp Test, and we found no prior research comparing Kemp Test results with other outcome variables after CMT.{Editors, 2024 #16738} Among clinical variables validated by research, reported extensively in manual therapy literature, and advocated in the Medicare guidelines for documentation by chiropractors, aside from NRS pain scores, only use of self-reported measures such as the Oswestry Lower Back Pain Disability Questionnaire are fully validated and operationalized.{Fairbank, 2000 #16739;Hawk, 2020 #16139} Yet even this dependent variable has only rarely been correlated with paraspinal tenderness.{Leach, 1993 #15773} Only NRS pain and Oswestry measures have been used extensively in reportage of outcomes after CMT.{Clohesy NC, 2018 #16743;Hawk, 2020 #16139;Himelfarb I, 2020 #16733} Neither algometry nor the Kemp Test have been previously compared with Oswestry and NRS scores both before and after CMT, to determine whether these reported measures of SDF improve after chiropractic, or even whether they correlate with one another. This lack of research regarding promising and/or commonly used chiropractic dependent variables may factor into our inability to clinically define the Medicare diagnosis SDF, and may instead serve to perpetuate the "enigma of back pain."{Waddell, 1996 #564}

Differences between instruments and protocols used in clinical trials, performed only on pain free subjects, using only one or a few sessions of SM, and with small sample sizes may have contributed to prior conflicting reports regarding the ability of algometry to distinguish pain free from painful lower back muscles; also, studies conducted in university or controlled environments may lack generalizability to clinical practice.{Jung, 2023 #16196} When an examiner measures paraspinal tenderness by using an algometer asking the patient to say "yes" when discomfort is first noted, the corresponding value read from the instrument is termed the pressure pain threshold (PPT). Emerging evidence that the number and frequency of CMT sessions may impact both short and long term outcomes gives rise to the question as to whether paraspinal tenderness is affected by the number and frequency of treatments as well.{Haas, 2004 #4710;Haas, 2014 #15996} For example, would SM twice a week for 4 weeks increase paraspinal PPTs and reduce PPT asymmetry (the difference between paraspinal tenderness on the right versus the left) more significantly than SM provided only once a week for 2 weeks? Extending the prior PPT work by reporting tenderness quantified by algometry along with other commonly reported and operationalized clinical measures, determining whether the variables improved as expected after care, and correlating the measures before and after chiropractic may help inform future prospective research of their validity with regard to measurement of SDF within the Medicare program.

Conditions

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Segmental Dysfunction of the Lumbar Spine Back Pain Leg Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pressure Pain Thresholds in 98 Patients with Uncomplicated Back and Leg Pain

A computer search (EZ Biz software) for patients diagnosed with sciatica (i.e., ICD10 codes M54.31, M54.32, M54.41, and M54.42) or uncomplicated low back pain (ICD10 M54.4 or M54.50) identified 492 electronic charts. Of these 394 either failed to meet inclusion criteria (n = 62) or met exclusion criteria (n = 332) and were eliminated from the study, leaving pre-and post-treatment data from 98 new patients eligible for statistical reduction. Charts of patients seen consecutively who had been treated between January 1, 2018 and August 25, 2021 who met inclusion and exclusion criteria were included.

Chiropractic

Intervention Type OTHER

SM used by the practitioner was the chiropractic side posture pisiform contact push move with a P-A thrust isolated to the lumbosacral joints and applied to the side of primary back and/or leg pain. Patients presenting with spondylolisthesis received a side posture distraction type maneuver instead of a P-A thrust. As pain began to subside during subsequent visits patients were transitioned to bilateral application of SM, rather than continuing treatment only on the side of back pain or radiculopathy.

Exercise

Intervention Type OTHER

Core spine stretch and strength training throughout the course of care.

Cryotherapy

Intervention Type OTHER

Therefore, during each treatment session when patients reported pain they received pretreatment with cryotherapy using a reusable ice pack (Polar Ice, Pelton/Shepherd Industries, Stockton, California) wrapped in 2 layers of headrest paper, but otherwise applied directly to the skin vertically along the lumbosacral spine, for 5 minutes.

Spinalator

Intervention Type DEVICE

When patients no longer reported leg pain, spinalator intersegmental traction at \~10 lb/F, while the patient was lying supine with an ice pack between the traction table and the lumbar spine, was permitted as a pretreatment to side posture lumbar manipulation.

Interventions

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Chiropractic

SM used by the practitioner was the chiropractic side posture pisiform contact push move with a P-A thrust isolated to the lumbosacral joints and applied to the side of primary back and/or leg pain. Patients presenting with spondylolisthesis received a side posture distraction type maneuver instead of a P-A thrust. As pain began to subside during subsequent visits patients were transitioned to bilateral application of SM, rather than continuing treatment only on the side of back pain or radiculopathy.

Intervention Type OTHER

Exercise

Core spine stretch and strength training throughout the course of care.

Intervention Type OTHER

Cryotherapy

Therefore, during each treatment session when patients reported pain they received pretreatment with cryotherapy using a reusable ice pack (Polar Ice, Pelton/Shepherd Industries, Stockton, California) wrapped in 2 layers of headrest paper, but otherwise applied directly to the skin vertically along the lumbosacral spine, for 5 minutes.

Intervention Type OTHER

Spinalator

When patients no longer reported leg pain, spinalator intersegmental traction at \~10 lb/F, while the patient was lying supine with an ice pack between the traction table and the lumbar spine, was permitted as a pretreatment to side posture lumbar manipulation.

Intervention Type DEVICE

Other Intervention Names

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Spinal Manipulation Intersegmental Traction

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Inclusion criteria included patients diagnosed with uncomplicated low back and/or unilateral leg pain regardless of severity or length of pain prior to presentation.

Exclusion Criteria:

* Exclusion criteria included: Patient with missing data on preliminary or follow up exam, initial OSWESTRY score \<20%, initial NRS LS/leg pain score \< 2/10, patient referred for exclusive care elsewhere, patient age \<18 and \>75, pregnancy, significant neurologic loss (more than numbness), MVA/litigation, patient with bilateral leg pain or diagnosis of central HNP, and patient seeing a staff doctor other than the principal investigator for this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No