Clinical Correlates of Pressure Pain Thresholds in Back and Leg Pain

NCT06653920 | Completed

• 1 other identifier: Life2022-24
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Segmental Dysfunction of the Lumbar Spine; Back Pain; Leg Pain

Keywords

case series; back pain; pain threshold; chiropractic manipulative therapy

Outcome Measures

Primary Outcomes (1)

• Measurement of Pressure Pain Threshold and Paraspinal Asymmetry by algometry.

  The algometer used in this study was obtained from Wagner Instruments (Greenwich, CT, Model FPK 20) and we followed the Fischer{Fischer, 1986 #16187;Fischer, 1987 #16211} method of standardized application (1 kg/cm2/sec) of rate of force that was followed for all exams by the principal investigator, applied 3 cm bilateral to the L5 spinous (Figure 1). Reliability and validity studies for use of an earlier version of this same instrument have been published previously.{Fischer, 1987 #16211;Fischer, 1986 #16187;Waller R, 2015 #16748}

  From enrollment to the end of treatment at 6 weeks.

Secondary Outcomes (3)

• Modified Oswestry Lower Back Pain Questionnaire

  From enrollment to the end of treatment at 6 weeks.

• NRS Lower Back and Leg Pain Scores

  From enrollment to the end of treatment at 6 weeks.

• Pain Provocation Operationalized Kemp Test

  From enrollment to the end of treatment at 6 weeks.

Study Arms (1)

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.

Other: Chiropractic; Other: Exercise; Other: Cryotherapy; Device: Spinalator

Interventions

Chiropractic 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.

Also known as: Spinal Manipulation

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

Exercise OTHER

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

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

Cryotherapy 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.

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

Spinalator 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.

Also known as: Intersegmental Traction

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The setting was a rural practice with patients diagnosed with lower back and/or leg pain, typically seen by a solo chiropractic practitioner in Mississippi. Treatment included both manual diversified side posture chiropractic manual thrust procedures and pretreatment typically used in Mississippi including ice if back and leg pain, or ice plus SpinalatorTM if not obese and without leg pain (due to practitioner experience that SpinalatorTM may aggravate patients with leg pain and obese). Ancillary advice and counseling may not have been typical of other practices since the chiropractor also holds certification as a Master Certified Health Education Specialist; training included practicing a set of core exercise strength and stretch exercises and instruction to stay active, as well as advice regarding in home/at work use of 5 minutes of ice 5x per day followed by walking and stretching to tolerance.

Sponsors & Collaborators

• Leach Chiropractic Clinic: lead

Study Sites (1)

Leach Chiropractic Clinic, LLC

Starkville, Mississippi, 39759, United States

Location

Related Publications (1)

• Leach RA, Hayes K, Sullivan S. Correlates of Pressure Pain Thresholds in 98 Consecutive Patients with Uncomplicated Back and Leg Pain: A Retrospective Private Practice Cohort. Abstract presentation at the 2024 Association for Chiropractic Colleges Research Agenda Conference. March 23, 2024.

  BACKGROUND

Related Links

• abstract presentation

MeSH Terms

Conditions

Back Pain

Interventions

Manipulation, Chiropractic; Manipulation, Spinal; Exercise; Cryotherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robert Leach, DC, MS, RMCHES

  Leach Chiropractic Clinic LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2018
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual participant data collected will be shared at 1 year after article publication for a period of 5 subsequent years.
• Access Criteria: IPD demographic and outcomes data will be made available upon request.

Locations

US (1)