Clinical trial NCT06469762: The Short-Term Effects of Dry Cupping the Lumbar Paraspinal Muscles in Individuals with Non-specific Low Back Pain
Official title: The Short-Term Effects of Dry Cupping the Lumbar Paraspinal Muscles in Individuals with Non-specific Low Back Pain: a Single-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-specific Low Back Pain
Keywords: Dry Cupping
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Once the ethics approval has been provisionally granted, the pilot study will be registered as a randomized clinical trial with finalized and approved protocol. After the registration has been completed, prospective participant recruitment will begin. The study recruitment will occur through the use of recruitment posters around Lakehead University and posted on the investigator's Instagram© and Facebook© pages. In addition, local chiropractic and physiotherapy clinics will be contacted to inquire about recruiting within their clinics and through their social media platforms. The investigators are targeting at least 60 participants to be recruited who are experiencing NSLBP, are otherwise healthy, are within 18-55 years of age, and consent to be a participant. Should the participant be currently receiving treatment for NSLBP or another musculoskeletal condition, a wash out period of 2 days (48 hours) will be ensured between their treatment and study participation. Exclusion criteria will include any individual with a previous or scheduled surgery to the lower body which may affect their hip and/or knee ROM, previously experienced trauma to the low back area, are diagnosed with a specific low back or lower body condition (i.e., spondylolisthesis, spinal stenosis, osteoporosis, or intervertebral disk derangement), are diagnosed with cancer, are experiencing referred leg symptoms, are confirmed or suspected to be pregnant, or with a confirmed or suspected blood/blood clotting disorder (i.e., hemophiliac).

After potential participants contact the investigator regarding their interest in the pilot study, a detailed information letter will be provided to them. The information letter will include details pertaining to the pilot study including the purpose, procedures, duration, potential session availabilities, and the location at which the research will take place. If the prospective participant is still interested in engaging in the pilot study, they will arrange an appropriate time to meet with the investigator for data collection. Three sessions will be scheduled, each approximately 48 hours apart (e.g., Monday, Wednesday and Friday). Each session will last about 60 minutes and will take place at Lakehead University in the School of Kinesiology Sanders Building in room SB-1025.

Participants will be randomly assigned to either a placebo or intervention group, which will be decided prior to the first session. Should the participant be in the placebo group and wish to receive treatment, they will be offered this opportunity upon the completion of the data collection session. In the first session, the potential participant will review and sign the provided consent form. The investigator will also explain the ability to withdraw from the pilot study at any time without penalty. After informed consent has been given, the participant will then complete the Get Active Questionnaire (GAQ) and a Participant Demographic form which will include information related to their gender, sex, age, height, and body mass. Should the participant respond "Yes" to any question on the GAQ, they must be cleared by their medical provider prior to participation.

At this point the intervention will begin, the participant will be asked to lay prone on the examination table, with their lumbar spine exposed. The investigator will landmark the L1 and L5 vertebrae and mark this location with a washable, skin safe marker. This will be located by palpating for the iliac crests and following them directly inward to landmark the spinous processes of L4. From there, L5 will be marked one thumb-width downward from the spinous process of L4, and L1 will be marked three thumb-widths up the spine after palpating the spinous processes of the respective vertebral bodies. From there, the investigator will measure 3 centimeters (cm) on each side of the landmarked spinous processes of L1 and L5, using the measuring tape. This will be done to standardize the location of the inclinometers, and all four locations will be marked using a marker. Next, the participant will be asked to identify their primary location of LBP (by pointing to the area; e.g., right side of L3), this area will be marked using a marker and will represent problem area one (P1). The participant will then be asked to name their secondary location of LBP (by pointing to the area; e.g., left side of L4), this area will be marked using a marker and will represent problem area two (P2). After the locations have been marked, baseline measurements will be taken. The skin temperature of the lumbar spine will be taken using the Maximum™ Laser Thermometer at P1 and P2 and the mean skin temperature will be calculated and recorded to the nearest tenth of a degree. Following that, the pressure pain threshold will be measured using the Wagner Force One™ Digital Force Gauge. Firstly, the participant will be asked to identify an area of no pain (e.g., the deltoid, triceps, or gastrocnemius), the pressure pain threshold will be measured at the indicated location, and the result will be recorded. This will be done by applying the tip of the Wagner Force One™ Digital Force Gauge perpendicular to the indicated area and applying a gradually increasing amount of pressure. The participant will be asked to indicate when the pressure sensation on the area transitions to a sensation of pain. At this point, the value indicated on the algometer will be recorded and the pressure will be removed. This will be used to establish a baseline in an area of no pain, and to familiarize the participant with the measurement tool. Next, measurements will be taken at P1 and P2, and the two measurements will be recorded to the nearest tenth of a Newton (N). Next, the participant will be asked to stand, and two inclinometers will be placed on the L1 and L5 landmarks on the ride side of the spine. The participant will be instructed to bend forward as far as comfortably possible. The mean of the two values measured by the inclinometers will be recorded to the nearest tenth of a degree. This will be completed again with the inclinometers on the left side and the mean of both the L1 and L5 values will be recorded. Following the measurements on both sides, the average of the right and left side measurements will be recorded. Finally, the participant will complete the Sit and Reach Test using the Sit and Reach Device. The Sit and Reach Test will be conducted by instructing the participant to remove their shoes and sitting on the floor with their back against a wall and legs out straight in long sitting. The feet will be placed into the foot pedals and their hands will be clasped together and resting on the metal measuring piece. The participant will be asked to keep their legs flat, and feet pressed against the pedals. They will then be asked to reach forward as far as possible, pushing the metal measuring piece with their fingertips. After 3 warm-up tries, the participant will hold the fourth trial for 3 seconds and the measurement will be recorded to the nearest tenth of a cm. The participant will also complete the Numeric Pain Rating Scale (NPRS) and be asked to indicate their current low back pain on a scale from 0 (no pain) to 10 (worst possible pain). Finally, the participant will complete the Roland-Morris Questionnaire, to assess their overall function. The questionnaire will be scored by the investigator and the result will be recorded. Further information regarding psychometric properties of this tool will be provided in the Outcome Measures section.

Following the baseline measurements, the cupping treatment will begin. Once again, the participant will be asked to lay prone on the examination table. The investigator will apply a light layer of skin adhesive spray to the participant's lumbar spine at the 4 cupping locations. This will be used to improve suction. Four medium sized Hansol© plastic cups will be placed superior and inferior to P1 and P2 (i.e., superior to P1, inferior to P1, superior to P2, and inferior to P2). Those in the placebo group will receive cups with holes punctured in them, so that the suction is immediately released, while the adhesive spray will ensure the cups remain in place and do not change the sensation for the participant. Each cup will be pumped three times using the hand pump for consistent suction (465 mmHg of pressure). The cups will be left in a static position for a total of 10 minutes. After the treatment is concluded, the suction will be released, and the cups will be removed and placed into a bin to be later disinfected by the hydrogen peroxide solution as per the manufacturer's instructions.

Immediately following the cupping intervention, the skin temperature of P1 and P2 will be taken again using the Maximum™ (Model N08064) Laser Thermometer and the mean will be recorded. The pressure pain threshold will once again be measured using the Wagner Force One™ Digital Force Gauge at P1 and P2 as well as the non-painful site, and the dual inclinometry lumbar flexion and Sit and Reach Test will also be repeated, and the post intervention results will be recorded as described previously. The participant will also complete the NPRS once again and be asked to rate their current low back pain on a scale from 0 to 10. Next, they will complete the Roland-Morris Questionnaire, to assess their overall function, and finally, they will complete the Patient Global Impression of Change Scale (PGICS) and be asked to reflect on their treatment experience and indicate if their condition is "very much improved" (1) to "very much worse" (7). Further information regarding psychometric properties of this tool will be provided in the Outcome Measures section.

The participant will be thanked for their involvement and offered to receive a copy of the results at the completion of the pilot study. If the participant wishes, their email will be recorded to forward the results at a later date. Once the participant has left, the investigator will disinfect the table, inclinometer, and Sit and Reach Device using a disinfectant spray. The cups will be washed in a bin of warm water with dish detergent. After they are rinsed, they will be dried with paper towel, and taken and placed into the pre-mixed 3% hydrogen peroxide solution for 10 minutes as per the manufacturer's instructions. The solution will be made by combining one part 35% hydrogen peroxide with 11 parts water. After 10 minutes, the cups will be removed and set aside to dry before being used on the next participant.

The procedures will remain the same for both the individuals in the intervention and placebo condition, however, those in the placebo condition will receive cups with two 2 millimeter (mm) holes drilled in either side of them, so that the suction is immediately released upon application.

In the second and third sessions, the procedures will be repeated as previously described, with the exclusion of the consent form, GAQ, and Patient Demographic Form.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
measure: Algometry
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
Secondary outcomes:
measure: The Sit and Reach Test
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
measure: Lumbar flexion inclinometry
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
measure: Skin Temperature
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
measure: The Patient Global Impression of Change Scale (PGICS)
timeFrame: Immediately after intervention #1, immediately after intervention #2, immediately after intervention #3
measure: Roland-Morris Questionnaire
timeFrame: Pre-intervention #1, immediately after intervention #1, pre-intervention #2, immediately after intervention #2, pre-intervention #3, immediately after intervention #3
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
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