Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653920
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Clinical Correlates of Pressure Pain Thresholds in Back and Leg Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Correlates of Pressure Pain Thresholds in 98 Patients with Uncomplicated Back and Leg Pain a Consecutive Case Series Chart Review
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
Detailed Description:
Across manual therapy professionals there is at present little agreement regarding how to quantitatively measure painful spinal lesions associated with uncomplicated back andor leg painWaddell 1996 564Hegmann KT 2019 16740Himelfarb 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 chiropractorsServices 2019 16731 Medicare guidelines for chiropractors specifically list use of algometry as an acceptable way to record paraspinal tendernessCMS 2019 16198 However research regarding paraspinal algometry to measure tenderness has to date yielded conflicting resultsJung 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 CMTCMS 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 CMTLeach 1993 15773Jung 2023 16196Nim 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 andor leg pain are reported Complaint of back pain only suggests facet syndrome while complaint of leg pain suggests disc syndromeCMS 2019 16198Hawk 2020 16139Editors 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 CMTEditors 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 operationalizedFairbank 2000 16739Hawk 2020 16139 Yet even this dependent variable has only rarely been correlated with paraspinal tendernessLeach 1993 15773 Only NRS pain and Oswestry measures have been used extensively in reportage of outcomes after CMTClohesy NC 2018 16743Hawk 2020 16139Himelfarb 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 andor 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 painWaddell 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 practiceJung 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 wellHaas 2004 4710Haas 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
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 practiceJung 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 wellHaas 2004 4710Haas 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None