The Short-Term Effects of Dry Cupping the Lumbar Paraspinal Muscles in Individuals With Non-specific Low Back Pain
NCT Number: NCT06469762
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-specific Low Back Pain
Interventions: OTHER: Dry Cupping
Sponsor: Lakehead University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12

Summary:
This pilot study will investigate the effects of dry cupping the lumbar paraspinal muscles on lumbar spine on range of motion, blood flow as indicated by skin temperature, subjective pain, pressure pain threshold, perceived treatment effect and overall function in individuals experiencing Non-specific low back pain. The intervention will occur across three treatment sessions, scheduled approximately 48 hours apart. Both an intervention and placebo group will be used an a pre-/post- comparison will be conducted.

Primary Outcome Measures: The Numeric Pain Rating Scale, A self-administered pain questionnaire that requires individuals to reflect on their current level of pain on a scale from 0 (no pain) to 10 (the worst possible pain). This is one of the most common methods of assessing patient subjective pain perception as it is easily understood and simple to interpret. This tool has demonstrated excellent reliability (r=.99) for assessing musculoskeletal pain and a very high intraclass correlation coefficient (ICC=.95). The MDC for this tool is 1.33 points. This score indicates the minimal change in NPRS score needed to assume a true change., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3|Algometry, A Wagner Force One™ Digital Force Gage will be used to measure the pressure pain threshold. It is considered the gold standard for measuring subjective pain. The pressure pain threshold will first be measured in a non-painful area identified by the participant (e.g. deltoid) to establish a baseline, which will be recorded. Next, it will be measured at P1 and P2 and the two measurements will be taken and recorded, both pre- and post-intervention. This tool has demonstrated good to excellent intra-rater (r=.75-.99) and good to excellent interrater (r=.81-.99) reliability in measuring low back pain. The MDC for this tool is 47.2 kPa., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
Secondary Outcome Measures: The Sit and Reach Test, A method for assessing lumbar spine ROM and will be used to make comparisons between pre- and post-intervention. This test requires the participant to sit on the floor with their feet pressed against the pedals on the Sit and Reach Device. They must then reach forward as far as possible while pushing a metal measuring piece with their fingertips. This tool has demonstrated a moderate interclass correlation coefficient (r=.57-.74) and an excellent intraclass correlation coefficient (r=.92), indicating its high reliability. The minimum detectable change (MDC) for the Sit and Reach Test is between 1.13 cm and 1.74 cm. This value indicates the minimal change in the Sit and Reach score needed to assume a true change., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3|Lumbar flexion inclinometry, A method of measuring lumbar spine flexion ROM. The use of dual inclinometers allows for one to be placed at both L1 and L5 and an average measurement to be taken. For this measure, the participant will be required to bend forward as far as comfortably possible, and the mean value will be recorded. This will be completed for both the right and left sides at the locations of the cups. This tool has demonstrated excellent interrater (r=.88-.94), excellent intra-rater (r=.90-.91) and excellent test-retest (r=.91-.93) reliability for measuring thoracolumbar spine ROM in individuals with LBP. The MDC for inclinometry is between 1.50° and 3.41°. This score indicates the minimal change in the inclinometry value needed to assume a true change., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3|Skin Temperature, The Maximum™ (Model N08064) Laser Thermometer will be used to measure lumbar spine skin temperature pre- and post-treatment. This will be measured in degrees Celsius (ºC) before and immediately after the cupping treatment at P1 and P2. The mean of the measurements will be taken and recorded., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3|The Patient Global Impression of Change Scale, A self-report questionnaire that requires individuals to reflect on their overall perception of a treatment or intervention. It allows individuals to make a comparison between their condition pre- and post-intervention and rate it from 1 (very much improved) to 7 (very much worse). It is a standardized method of measure patient report outcomes with a high test-retest reliability (ICC=.84) in patients with LBP., Immediately after intervention #1, immediately after intervention #2, immediately after intervention #3|Roland-Morris Questionnaire, A validated measure commonly used by practitioners to assess physical disability caused by low back pain. It is a self-report questionnaire that is scored to obtain a functional score. The patient is asked to indicate when a statement applies to that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability). This tool has demonstrated excellent intra-rater reliability (ICC=.91), with moderate internal (r=.71) and external (r=.54) responsiveness. The MDC for this tool is 5 points., Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3