The Short-Term Effects of Dry Cupping the Lumbar Paraspinal Muscles in Individuals With Non-specific Low Back Pain

NCT06469762 | Completed

• 1 other identifier: LakeheadU-Scavarelli
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will investigate the effects of dry cupping the lumbar paraspinal muscles on lumbar spine on range of motion (ROM), 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 (NSLBP). 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.

Conditions

Non-specific Low Back Pain

Keywords

Dry Cupping

Outcome Measures

Primary Outcomes (2)

• The Numeric Pain Rating Scale (NPRS)

  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 minimal detectable change (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 kilopascals (kPa).

  Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3

Secondary Outcomes (5)

• The Sit and Reach Test

  Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3

• Lumbar flexion inclinometry

  Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3

• Skin Temperature

  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 (PGICS)

  Immediately after intervention #1, immediately after intervention #2, immediately after intervention #3

• Roland-Morris Questionnaire

  Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Individuals in this condition will receive treatment using plastic cups with two 2 mm holes drilled in either side of them, for all three treatment sessions.

Other: Placebo Dry Cupping

Intervention

EXPERIMENTAL

Individuals in this condition will receive treatment using regular plastic cups, for all three treatment sessions.

Other: Dry Cupping

Interventions

Dry Cupping OTHER

Dry cupping treatment session, using 4 regular plastic cups on the lumbar spine for 10 minutes.

Intervention

Placebo Dry Cupping OTHER

Dry cupping treatment session, using 4 plastic cups with two 2 mm holes drilled in either side of them, on the lumbar spine for 10 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females;
• Between the ages of 18 - 55 years;
• Experiencing NSLBP; and
• Otherwise healthy, and successful completion of the GAQ (Should the participant be currently receiving treatment for NSLBP for another musculoskeletal condition, a wash out period of 2 days (48 hours) will be ensured between their treatment and study participation).

You may not qualify if:

• Any individual with a specific low back or lower body condition (e.g., i.e., spondylolisthesis, spinal stenosis, osteoporosis, intervertebral disk derangement);
• Any individual with a previous or scheduled surgery to the lower body, which may affect their hip and/or knee ROM;
• Any individual with previous trauma to the lower back area;
• Any individual who is diagnosed with cancer;
• Any individual experiencing referred leg symptoms;
• Any individual who is confirmed or suspected to be pregnant; and
• Any individual with a confirmed or suspected blood/blood clotting disorder (i.e., hemophiliac).

Sponsors & Collaborators

• Lakehead University: lead

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B5E1, Canada

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their treatment condition.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial with an intervention and placebo group. 2 x 2 x 3 mixed design, measures will be taken pre- and post-treatment in all 3 treatment sessions.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: June 24, 2024
• Study Start: November 1, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)